The recording of this workshop will be available for IGCS members to view through the IGCS education portal. Today, we are excited to have two wonderful speakers who will be sharing their expertise with us. Our first speaker is Dr. Allison Brand, the Director of the Department of Gynecological Oncology at Westmead Hospital and Associate Professor at the University of Sydney in Australia. Then we have Dr. Rachel Sisodia, Senior Medical Director for Specialty Care and Patient Reported Outcomes at the MassGen Brigham where she's an attending surgeon in the Division of Gynecologic Oncology at Massachusetts General Hospital in the United States. During the course of this workshop, we encourage all of you to submit questions via the Q&A feature at the bottom of your screen, and we will do our best to address as many questions as possible. And last but not least, I would like to introduce my co-moderator for this workshop, Dr. Rhonda Farrell from the Department of Gynecological Oncology at Lifehouse Hospital and Associate Professor at University of Sydney, Australia. Rhonda. Thank you, Navia, and good morning, everyone. It's great to be part of this workshop. I'm really pleased to present our first speaker, Dr. Allison Brand. Allison has extensive experience in the design and development and conduct of clinical trials. She was the previous chair of ANZCOG, our Australian New Zealand trials group, and she's the chair elect of GCIG. So I'm sure she's going to be fantastic, give a fantastic talk this morning. We thank Allison for her giving up her time and for participating in this session. Thank you, Allison. Thanks very much, Rhonda. It's great to be here and to contribute to this workshop. So I'm looking forward to a very interactive session. So the plan is to show two relatively short videos. The first is a video presentation by Dr. Keiichi Fujiwara, who's the president elect of IGCS and the immediate past president of GCIG. And the second is a video presentation by Dr. Keiichi Fujiwara, who's the president elect of IGCS and the immediate past president of GCIG. So he really does have a bit of an insight into both organizations. And he will talk about the GCIG mandate and vision and how that marries in with the CCRN as well. After that, there'll be a second short video on trial types and designs for studies. So I think we should probably start the first video. All right, thank you for joining the Yami University at the symposium. So I'd like to send you some message before I open my slide discussion. So in this symposium, you have been learning so many important technical aspects for the clinical trials. So now I'd like to tell you why you have been invited here in the Gynecological Cancer Intergroup Education Session. So the gynecological cancer research has been unique situation worldwide. So our predecessors have tried and sought to overcome the issues for the clinical trials for gynecological cancer patients all over the world. So in the next 15 minutes, I'd like to talk about who we are, why we are here and what we have done and what we will do in the future. So next slide, please. So this is the kind of the brief definition of the GCIG and CCRN. So GCIG is Gynecological Cancer Intergroup, CCRN is Surgical Cancer Research Network. So both GCIG and CCRN promote clinical trials in global scale. And CCRN, however, focuses on the surgical cancer only and also CCRN allows the members are based on sites, members are based on sites, although the GCIG are based on the trial groups. Next slide. So this is a kind of a schema of a structure of the GCIG and CCRN. So please take a look at it later for the details. Next slide, please. So I'd like to mention the very, very basic question. Why do we need clinical trials? Because we want to change the practice to better serve for the patients. And we need the better evidences that we have been created before. So we need to conduct a clinical trial. It's very clear. Next slide. So next question is why do we need international collaborations? And the answer is that instance of gynecologic cancers, malignancies is relatively rare compared with other more common tumors such as colon, lung or breast cancer. So accomplishing a large scale phase three trials speedily is often difficult by single country. So that's just a short distillation about what GCIG and CCRN is all about for those of you who might not know about that. And so I'm just gonna do a little short presentation now about clinical trials. And I wasn't 100% sure what the level of knowledge about clinical research and clinical trials was. So apologies if I've dumbed this down too far, but I think it's always important for all of us to remember why we're doing clinical trials and what we really need to have as requirements before doing clinical trials. So I always think that the first thing that we need for when we're thinking about a research project or a clinical trial is we need a great idea. And years ago, someone told me that scientific research is seeing what everyone else has seen, but thinking about what we can do to improve it. And I think that's why clinical research is so important is that we need to start thinking about different things. We'll go back to the previous slide, please. We need to think about what we could change, how we can do things differently. It's not just about new drugs, although obviously that's a really important part of clinical trials. But as a surgeon, I'm less interested in new drugs and more interested in how can we change the way things we do in our lives. How do we change the way we do things? Are there any new surgical techniques that we can do? Are there different ways of administrating radiotherapy? There's lots of different ways of thinking about what sort of trial you might want to do. And all it starts with is a great idea about something new and different. Next slide, please. So the next thing you need is you need infrastructure. And obviously, first and foremost, whenever we're considering a clinical trial is that we need to have patient protection requirements in place. And that's really all came about as a result of the Nuremberg Code of Ethics and the requirements about patient protection, patient consent, the ability for patients to withdraw at any time from a clinical trial, the fact that the consent has to be voluntary. And so an appropriate governance and ethics platform needs to be in place at the hospital or site where you're conducting your clinical trial. You obviously need an appropriate database. The most important thing, I think, is you need trial coordinators who are conversant in good clinical practice and who are going to be thorough in their collection of data and the documentation of what's going on with the patients. And I know in many low resource countries that the data collection and trial coordination is often run via doctors and junior medical staff. And that's great. And if that's necessary, then that's fine. But still, no matter who is doing the data collection and running the trial, they really need to be conversant in good clinical practice. The other thing is that trials cost money, and especially if there's drugs involved and they are not paid for by a drug company, there's also additional tests and additional time that's required. So money is needed. There's no doubt about that. And finally, and perhaps most importantly, there is a requirement for data and safety monitoring. And that's not only for patient safety, but it's also for data integrity. And as you will know, there have been not infrequently reports in journals as high up as the New England Journal of Medicine where the data has subsequently been interrogated and found to be lacking. And that's obviously not something that we want to have in our clinical trials environment. Next slide, please. So the other thing you need is collaborators. You cannot do a clinical trial by yourself. So you need to get buy-in from your colleagues at your site, which is the first big step. You also, depending on how many patients you need, will need to get collaborators from outside your site. And if you can get several people who are interested in your clinical trial from outside your site, and it's a clinical trial that involves cervix cancer, then you could potentially, after going through a number of hoops, be involved in a CCRN trial. The requirements for GCIG are different. The member groups are national clinical trial groups. And so if you want to be involved or you think your study is good enough to be a GCIG study, then you need to put that forth to your national clinical trials group and see if they will take that on. But no matter how big or small your trial is, you need to have collaborators. And next slide, please. So the fourth thing, which is probably the most important thing, is you need to have what I'd like to call PEPC, which is enthusiasm, perseverance, patience, and the ability to compromise. So as with everything in medicine, nothing happens quickly, nothing happens easily, and no one has exactly the same vision as you do about what you want to do in your trial. There'll always be people saying, we don't quite do it this way in our study or in our center. Let's just modify this a little bit. So another mentor of mine said many years ago, Alison, if you wait for the perfect trial, you'll never do clinical research. And that's because compromise is a really important part of getting a clinical trial up and running. Next slide, please. So the other thing I want to say is that trial design is important, and there's no point in wasting your time and effort spending years getting a clinical trial up and running, doing the clinical trial, and then finding that your trial design was not suitable for answering the question that you asked. And I think this segues very nicely into the next presentation, which talks about trial design. Hello, everyone. Thank you for your participation in 2020 GCIG Young Investigator Program. Clinical trials are run in multiple steps that build on one another, and each phase is designed to answer specific questions. For example, phase one clinical trial is designed to test a question regarding the safety and recommend a phase two dose. Phase two study is designed to assess the clinical activity, and phase three study is designed to evaluate efficacy. Let's look at more details. Phase one clinical trials test the safety, side effects, tolerability, best dose of the investigation new drug for further studies. Phase one clinical trials also look at what the drug does to the body, known as pharmacodynamics, and what the body does with a drug known as pharmacokinetics. It is usually conducted in a three plus three dose escalation design. And here is a three plus three dose escalation design. Three patients are initially ignored in a given dose level. If there is no dose-limiting toxicity in any of these three patients, the trial proceeds to ignore additional three patients into the next higher dose level. If one patient develops a dose-limiting toxicity, the trial proceeds to ignore additional three patients into the same dose level. If more than one patients develop dose-limiting toxicity in a specific dose level, it determines a maximum tolerated dose, and no further dose escalation will be done. Phase two clinical trials use a predefined and consistent dosing and scheduling of the investigation new drug based on the findings from phase one trials. Phase two clinical trials are usually conducted in the homogeneous population, and the sample size is usually determined by the power calculations. And the primary endpoint is the clinical activity, and phase two clinical trials may be randomized between the treatment regimens or with the placebo controls, or it can be single arm phase two clinical trials. Phase three clinical trials randomize a patient between the new treatment and a standard of care therapy to test a question regarding whether the new treatment is better or equal to the standard of care therapy with the same type of cancer. It may use blinded treatments and placebo controls, or it can be open-label study depending on the characteristics of the drug. Let's look at the NRGGI05 as an example. This is a randomized phase two and three study conducted in the platinum-resistant recurrent ovarian cancer. The primary endpoint of the phase two study is a clinical activity as measured by the response rate for rhesus criteria. Patients are randomized into one of four arms, including standard of care chemotherapy and investigational drugs. After evaluation of the phase two study findings, it was determined the drug will occur in the single laser arm for the phase three study evaluation. Phase three study tests the efficacy of investigational drugs compared to standard of care chemotherapy, and co-primary endpoints are proliferation-free survival and over-survival. This study recently concluded a co-op as of October 2nd, 2020. And this is NCIC-sponsored international trial. There is randomization between the investigation drugs and standard of care therapy, and this is open-level, and there is no placebo control, and it was designed to test superiority over standard of care chemotherapy. Besides this regular drug development approach, there is a mechanism in the United States for expediting drug approval. When investigational new drug provides meaningful therapeutic benefit over available standard of care therapy in a serious or life-threatening condition, such as recurrent cancer or tremor-respective cancer, FDA grants approval to the new investigational drug based on the phase two clinical data under the condition of pending phase three clinical trials. And recently, SES2 Smeglovitikin was approved for metastatic triple-negative breast cancer. And last year, Pembrolizumab plus Lambartanib was approved for the advanced endometrial cancer with a condition of pending phase three confirmatory trial data. It is important to keep in mind, even after the drugs enter the market, if other trials fail to show the predictive clinical benefit, FDA will withdraw the approval. In 2011, U.S. FDA announced a withdrawal of Bevacizumab for breast cancer because subsequent phase three clinical trials failed to show the predictive clinical benefit. Having said that, international collaboration is an invaluable mechanism to advance the knowledge of the investigational new drugs in a timely fashion. It can provide early access to the potentially promising drugs in many countries where there may be no access to these drugs. By doing a collaborative work, we can complete the trials more rapidly and even randomized clinical trials are feasible for rare subtypes of tumors. The findings from these international clinical trials can be more generalizable across the countries. Moreover, a focus is made where global interest exists. International collaboration also bring the challenges. There are differences in the culture, clinical practice, ethical frameworks, and research experience and available resource in many different countries. There are also cultural biases of patients and their family members, sometimes even in the research teams, bringing another barrier. In most cases, no news is not good news. A lack of a clear communication and suboptimal education for the patients may lead to the early stopping of the drugs and poor compliance. Moreover, the investigators may feel loss of autonomy during the collaboration. Considering these challenges, it is necessary to have a solid safety and tolerability data from the phase one clinical trial before launching the international studies. For the international trials, the mid-size randomized phase two or randomized phase two and three would be more applicable for the rare tumor types to assess the possible clinical activity in a timely fashion. There are published GCIG consensus review as to the rare gynecologic cancers and clinical trial disease as shown here. In terms of drugs, available resources and cultural background in each country should be considered, especially for drugs requiring close monitoring and follow-ups for the compliance and safety reasons. Also, different regulatory process in different countries should be counted for potential drug registration. More details will be discussed by the next two speakers as to the regulatory process and international collaboration. I'd like to thank the organizers for the GCIG Young Investigator Program and thank you for your attention. So thanks for that. If I could have the next slide, please. So I think the important things in Dr. Lee's presentation, aside from the discussion about trial design, is moving from trial design and what trial you are going to conduct in your country. And I don't think we can underestimate the issues that are involved with having international trials. And one of the very important groups in GCIG is the Operations and Harmonization Committee. And certainly when I started going to GCIG in the very early days, I thought, what is this Harmonization Committee? Is it all just about a committee that tells us how we should all get along well together? Well, no, that's not what it does. What it does is try and harmonize the requirements across multiple countries to try and make sure that the regulatory requirements for each trial, the trial that we do in each country are aligned. And that has proven to be perhaps one of the most challenging things to do with international trials in GCIG. So I just thought I might conclude with some discussion about what the benefits of clinical trials are. And I'm sure many of you know all of this. And when we talk to patients about clinical trials, patients, especially if they're randomized clinical trials, often will be a bit reluctant to consider a clinical trial because they are concerned that it might be an experimental treatment and they think that they don't want to be part of an experiment. But what I do is I emphasize to them the fact that this has gone through multiple checkpoints to make sure that this is safe for patients. It has been reviewed by multiple ethics committees and that at a very minimum, the patients will get access to a standard of care. And at maximum, they might get access to new drugs or new treatments that they might not otherwise be available to them because it hasn't come on to the market. And finally, and this often is a reason that many patients will consider a clinical trial is that they want to contribute to scientific progress. For doctors, we all want to be able to access the best new treatments for our patients. There's no doubt that if you're involved in clinical trials that you have improved quality of care because there are so many more requirements for oversight with clinical trials than there are for standard of care. But that improved oversight often runs over into your care for your patients who are not on clinical trials. And then all of us as doctors want to contribute to scientific advancements and improved outcomes. And then when your hospital is bulking at the thought of providing a trial coordinator or providing infrastructure for your clinical trials, I think it's really important to remind them that we know that patients who are involved in clinical trials, doctors who are involved in clinical trials and hospitals that are involved in clinical trials will have improvements in care just because of the improved quality of care that undoubtedly results, not only from the patients who are involved in the clinical trial, but those who are not involved in a clinical trial. And what I like to say to everybody is that all advances in cancer treatments have been made on the back of clinical trials. And so if we hadn't had those clinical trials that were done in the 60s and 70s and 80s, then we wouldn't be where we are today with cancer treatments. And that's a powerful message for all levels of people that are involved in clinical trials. So that's all that I have to say right now. And at the end of the sessions, then I'm very more than happy to answer any questions that people might have. Thank you. Thank you so much, Dr. Brand. And to all our panelists, we really apologize if you had trouble hearing the video and we've shared the link to each of the videos and we'll be sending that as an email to you after this workshop as well. Now we'll move on to our next speaker, Dr. Rachel Sisodia, who will be talking to us about assessing patient reported outcomes. After Dr. Sisodia's presentation, we will have time for the Q&A portion. So please feel free to submit questions in the Q&A feature. Dr. Sisodia. Thank you so much, Dr. Mayer. I will share my screen. Can everyone see that? Yes, I'm hoping. Yes, we can see that. Perfect. Thank you so much. So I'm so delighted to come and speak to you all tonight about patient reported outcome measures, which is really a true passion of mine. Just by way of introduction, as we stated, my name is Rachel Sisodia. I'm a GYN oncologist in the United States in Boston. I practice at Massachusetts General Hospital and I'm an associate professor at Harvard Medical School. And currently within our healthcare conglomerate, which includes Mass General Brigham and Women, as well as 13 other area hospitals, I oversee specialty care and patient reported outcomes. And my goal today, I think we were asked to speak not just on patient reported outcomes, but actually just some sort of early career advice for how you find your way and navigate as junior faculty a career in research. And so let me just move the view. One of the single most important things really that I wanted to show in the first couple of slides is that I know when I was a very junior faculty, now I'm in my sixth year of being an attending surgeon, I wasn't sure what I wanted to do research in. I was the first physician in my family. I was from a very rural part of our country and I always knew I wanted to be a doctor, but my background was actually in philosophy and women's studies. And from medical school on, I knew I wanted to be a GYN onc and I completed training in Boston and then stayed on a staff at MassGen. And then in my early career, there was really no area candidly that I was particularly passionate about outside of the concept of how do we know we're doing the right thing for the patient? As you all know, as GYN oncologists, we're constantly balancing morbidity, mortality, risks, benefits, right? And I was always, especially with my background in philosophy, interested in the nidus of that with the patient. But there's not a huge market for that in healthcare and I didn't wanna kind of be pigeonholed into ethics. And I generally wrote things that were sort of in the interest of people senior to me and candidly, it was grueling to write, right? Because I wasn't passionate about it and I was executing other people's passions. And early on, I applied for several grants that didn't get funded regarding actually decisional regret in patients. And I remember when that happened, I was in my second year of being staff and I just had this thought of like, I have no good ideas. And I really resonate with Dr. Brand's comment earlier, which was that you need to see things that other people see that think about them differently. And the picture on the right is my mentor. This is Marcella Del Carmen. She's a GYN oncologist also at Mass General. She's well known. There's probably some people on this call that know her and she was a real mentor of mine and kind of shepherded me through this. And what I wanna say just first and foremost for everyone on the call, that having an amazing mentor was the single most important thing in my professional career. So during that time where I'd been turned down for a couple of grants and was kind of trying to think about what my career should look like, Dr. Del Carmen took the position as Chief Medical Officer at the Massachusetts General. And I like to always tell the story that I was actually on my medical leave after delivering my first baby and Marcella called me and said, hey kid, do you wanna come over and be one of my assistant medical directors in our physician's organization? There's some work that needs to be done and I totally trust you. And I didn't even ask her what that was, I just said, yes. And this led to this series of career advancements and developments that totally changed the trajectory of my life. So currently I'm 50-50 admin and clinical and because of that decision, me saying yes, two weeks postpartum, I oversee the world's largest PRO program now five years later. And my research administrative and clinical career has all nested nicely. I'm the co-chair of the SGO, Society of Gynecologic Oncology Quality Task Force. I sit on several executive or excuse me, advisory panels for National Quality Forum and CMS and lots of advisory boards and recently was promoted. So I bring that up to say, you should always say yes to people you trust and I'm happy to talk more about that later but if you take anything, even if you don't learn anything about patient reported outcomes, that's the single best piece of advice I can give you. But let's move on to why people wanted me to speak tonight which are PROs. So let's talk about PROs and these are PROs basics. So the first thing that I would say is these are definitions that you're gonna hear me throwing around and I'm not sure what people's expertise is in patient reported outcomes but a PRO or a patient reported outcome is any symptom, health behavior, functional or mental status that comes directly from the patient without interpretation of a clinician. Sorry, I didn't just mean to make that small. An example would be depression, right? And or angina. And a PROM is a validated measure that tests that symptom, right? So for depression example be a scale called the PHQ-9 and for angina it would be the Seattle Angina Questionnaire. And what this is, is essentially they're validated measures that ask patients about these symptoms, right? And it doesn't require a doctor to say, hey, how are you feeling? How's your mood been? Have you been a little depressed? We don't interpret it. We just get the data back and it converts subjective experience of disease into an objective parameter. And a PRO performance measure is a quality metric based on a PROM, right? So an example of that is the percentage of patients, for example, in your healthcare system who come in with a depression score of nine, which is bad. And then within six months, you can get them to less than five. And in the United States, we actually wager money with insurers and payers that we will hit certain targets on these. And why are PROs important, right? So what I would say is healthcare, at least in the United States, has tremendous difficulty measuring quality and value. So we always measure what we can, but we don't necessarily measure what's important. So in our hospitals, right, we are excellent at measuring 30 day readmissions and hospital acquired infections and unplanned ICU and renal failure and transfusion rates. But as a GYN oncologist, and I know you all can empathize with this, I have never had a patient say to me, oh, Dr. Sisodia, I am so glad I didn't get admitted to the ICU after that debulking in an unplanned fashion. That would have been terrible. My life would have never recovered, right? They don't care. Patients don't care about that. What they care about is how is my quality of life gonna be after the surgery? Am I gonna need a colostomy? Am I gonna lose functionality? Will I be able to be sexually active? Can I remain independent? Am I gonna feel like I used to, or am I gonna change? And PROs really are the way that we answer those questions, right? And I would argue are a tremendously more meaningful way to measure the quality of care that we provide. Nationally and internationally, PROs growth is explosive and it's an emerging standard of care. It's been used in Europe for a long time. Here on the left is a prospective trial that was published in JAMA in 2017 that looked at overall survival results in a prospective trial where patients with metastatic malignancy at Memorial Sloan Kettering were randomized into one of two cohorts, one of which got routine PROs, the other who didn't, just got routine usual care. And for the PROs, the intervention was simple. You just acted on it in a pragmatic fashion. So if the patient said they had neuropathy, right? You may refer them to neurology. You may titrate their gabapentin. You may do something like that. If they had nausea, you treated that better. And in this study, just the routine use of PROs to augment your care led to a six month overall survival advantage. So when we're talking about clinical trials, I think we all know that in patients with metastatic malignancy, increasing their length of life by six months would be a blockbuster, right? That would be a drug that was worth millions and millions and millions of dollars. And it's just by asking people how they feel in a validated way. You can also look to get to the research point in the literature, right? The exponential growth in PubMed for PRO publications. The program I actually oversee right now is the largest in the world. We've collected over 10 million PROs with our next competitor being University of Utah who has collected about 3 million collections. I bring that up not to brag about that, but just to say we have a lot of experience. And one of the things I'm gonna talk to you today is about starting PRO programs where they are, right? We've stood up about 200 different clinics, people at all different levels of resources from pediatric asthma clinics to neurosurgery clinics. And so I wanna kind of take people where they are. If you're interested in some of that implementation science, that's a paper there that you could pull that will speak to that. But PROs are really only gonna become more prevalent and are increasingly used nationally in the United States in strategy payment marketing. So Center for Medicare and Medicaid, which for those of you who don't live here, they essentially drive everything we do. And over the next five years, they have pledged to increase the number of care models that include PROMs collection by 50%. The insurers are about to start requiring performance metrics on PROs. That's actually like you have to hit a target of patient reported improvement to be paid. We recently piloted that with two separate insurers here, and it's been seen in newer and more recent CMS models and actually National Quality Forum who also guides a lot of the work done here has been convening groups to make formal recommendations on how to do this. Purchasers of insurance, meaning the people that represent the employers, right? Have whole divisions now looking at how to advocate for PROMs for their constituents, essentially for the people that they represent and multiple PCORI grants to try to understand how patients need to view that. And so for the more concrete people, and I always, I gave a talk one time and at the end of it, after an hour, someone said, so what does a PROM look like? And I thought, my God, I have failed, right? In this talk. So I put this up front. This is an example. It's not a GYN oncology example. I chose an easier one. This is an example of a PRO that we use in my healthcare system for spinal fusion or for people that come in with back pain and who are a candidate for a spinal fusion surgery. You can see on the left, the questions, right? There's only 10 and they're pragmatic and they were validated in other patients with back pain, right? So pain intensity, I can tolerate the pain I have without having to use painkillers all the way to painkillers have no effect on my pain and I do not use them. And then you can see all the other constructs. And then here, one of the things we would do with this is we have, these are thousands of patients and we would plot them over time, right? So the vertical line represents surgery, preoperatively, leg pain scores when you have a slipped disc or at about a six, right? Postoperatively, they go down to a two. For spine surgery, that's a very important difference. And you can see also, right? That change is persistent and it perseveres over time. You can imagine what this can do for your counseling, right? For patients to say, this is where you are, this is where you'll end up, right? It's very good for shared decision-making. And in the clinic, what does it look like? Well, almost all PROs can be administered on paper. So again, another reason why I like this is that you don't have to be in a heavily resourced environment like we are to administer PROs. You can give them right on paper. We do it via tablet. This is again, an example in the orthopedics clinic and don't worry, I'll talk about GYN-Arc specifically, but you can see a patient gets a tablet, this patient's there for hip pain, it says for your right hip, do you have a limp? And then you had it on a Likert scale, same thing. Then it goes to how well do you climb stairs? You put them all in and then the system tallies it and it's immediately available for the physician to view in the encounter. This is a fake patient, an epic, don't worry, I'm not violating anyone's HIPAA or privacy. And if they have an abnormality, if you hover over it with your cursor, you can then see why is it abnormal? Well, in this case, in 2017, one month prior, the patient did not have myalgias, but at the time of this visit, that had increased, right? And so the physician can immediately look at this and know, is there a problem or not? I'm gonna take a minute to talk about how is a PROM created? Because I do, I find I often get questions that say, well, where do these come from? Do these really like, are they effective at this? There's a huge science around it called psychometrics. And the following slides are courtesy of Dr. Andrea Pusich, who is a colleague of mine and really, an amazing mind in the field of patient-reported outcomes. She's a plastic surgeon, but she herself has developed, you can see the following questionnaires, many of which focus on reconstructive attempts after the following surgeries. And so how are PROs developed? And again, start thinking about areas in which you'd be interested in research and taking from this. But the first phase is item generation or scale development. Take any individual construct or any individual disease, any individual symptom, what should we measure? What do we wanna measure? Do we wanna measure pain? Do we wanna measure quality of life? Do we wanna measure cognitive function? Or do we wanna measure all of these things? And which questions are most effective? And what are the measurement properties? Is there a ceiling effect? Is there a floor effect? How sensitive is it, right? Is it valid in multiple languages and multiple cultures? And then the third phase is does the instrument work? Does it actually test what we want it to? This early phase is qualitative. It's based on very structured interviews, rigorous qualitative interviewing techniques. But then at the end, it moves to a very highly quantitative process. And I'll go through that very quickly. So an example from her slides is the CLEFT-Q. And so this was a PROM that was developed for children with a CLEFT palate, okay? And it provides meaningful measurement of how they feel about their repair. So this is intended for patients who have undergone a CLEFT palate repair. And you can see that this is the publication, again, these phases, right? What should we measure? How should we measure? How does the instrument work? And you can see all of these systematic reviews, interpretive description, clinician input. They're interviewing patients throughout all this. They took it to a pilot field test, then an international field test throughout all of these countries, right? Testing different patients. And here's sort of the items that you would hear. So this first interview, right, was a Kenyan boy, age nine. When I am eating the food, it comes out through my nose. So I feel embarrassed, like I wanna be away from the people. So this is a really rich comment, right? They're talking about eating. It's a functionality that's a daily activity that he has difficulty with. And then he talks about how he feels about that, embarrassed, right? So these are constructs that, again, you flag, the psychometricians do. And they see, is this repeated with other patients? And then this young woman, age 14. I used to be quite shy because I didn't want to talk as much because I was worried that people would point it out or something. And then it would be upsetting when people asked me to repeat things, right? So worried, again, like embarrassed, similar way of describing the psychological impacts of this disease. And then when she talks about speaking and repeating things, right? It's similar to eating, it's functional difficulty. So when you do all these interviews with multiple people, you start to generate themes, right? And so in this case, for example, there were almost 3000 patients. Most of the themes came from appearance, psychological themes like worry, anxiety, social themes. How do I interact with other people? Maybe I'm embarrassed to have dinner with my friends or physical themes like eating or repeating your language. And then ultimately this led to things in the appearance, such as face, lips, nose, nostrils, cleft scar, speech, social, physical, psychological. And this is how this prong was created, right? All these buckets started to come forth and then were then validated. You can see, and this is my last example here before we dive into how all this relates to GYN oncology and the area I think is most ripe for research is for example, for the appearance here, they talk about how much do you like how your face looks when you look your best, right? You're made up and ready to go to a wedding or a party all the way down to how your face looks up close, right? And it sort of spans. Each one is a little jump, how your face looks in the mirror, when you smile, how well your face matches, how your face looks in photos. And it's on a Likert scale, one to 10, right? And oftentimes you'll get patients that can get a certain way, like they like how their face looks in photos, but if someone's up close, they don't like that. And it gives the surgeon the ability to sort of titrate A, expectations and B, understand if the patient isn't happy with the outcome and they need to revise. So how do PROs relate to GYN oncology in particular? This is sort of, I gave you kind of a basic overview, at least in the United States of PROs and how they're used and why they're becoming increasingly important, as well as some just basic primer on how PROs are developed. So PROs and GYN malignancy are grounded in two systems. The functional assessment of cancer therapy or the FACT scale, which is originates in the United States and the EORTC scale, which comes out of Europe. This is an example of the FACT-O. These are two of our scales for ovarian cancer, right? So this is the FACT-O, that's the American version and the EORTC QLQ of 28 is the European version. These are generalized tools in this example for ovarian cancer to test a variety of constructs. Remember from our cleft Q example, we had appearance, psychosocial, cognitive or physical. Here's something for FACT-O, physical wellbeing, right? I have a lack of energy, I have nausea, I have pain, I feel ill, I'm forced to spend time in bed. Same thing, you can see social family wellbeing and I'm sure a lot of this will resonate with you with your patients. Same thing, QLQ of 28, right? So you have all of these different things, tingling, numbness, weak, aches and pains, all things that a patient could complain of. The FACT and EORTC as I just said are multi-domain tools that assess broad functioning in many areas. And both of these global systems, FACT system and EORTC have a general scale, FACT-G and the EORTC QLQ-C30 and this can be administered to any patient with cancer, but then they have subscales as well. So which is what I just showed you. So the FACT has the FACT endometrial which is uterus, FACT-O for ovary, FACT-CX for cervix and FACT-B for vulva. EORTC has one for uterus, ovary, cervix. There are no scales that are dedicated to vaginal cancer, trophoblastic disease, patients with genetic predispositions or sort of other less common diseases. And there's tons of additional scales that can be used based on what you're trying to tease out. So the PROCTCAE is a very famous one that's used for chemotherapy alone, adverse effects. I don't love that as much in GYN on patients because it was primarily derived in patients who are mainly undergoing chemotherapy. And as you all know, many of our patients are multimodality treatment with surgery, radiation and chemo and the GYN scales are better or the FACT and EORTC scales are better equipped to handle that. PROMIS emotional and instrumental support. Those are two scales I ask in my clinic. They look at actually the amount of support the patient has at home. Do you have someone that can help you if you're confined to bed? Do you have someone to talk to if you need it? There are lots of other PROMIS scales. Say if in your clinic you wanted to focus on abdominal pain or emotional wellbeing or depression, there's a scale for it. Just go to PubMed and you could find it. There's the female sexual function index which is about 50 questions just on that and so on and so on. Any validated tool is okay to use but they all have pros and cons, right? And one of the things I always highlight to people is that you really shouldn't ask a patient more than 40 questions. We have published data that shows that once a patient is more than 40, they're really kind of tapped out and they're gonna stop answering. Currently in the United States, the SGO has really been an early adopter in the push to use PROs. We published two white papers that came out in 2020 that made actually pretty explicit recommendations about the PROs that we currently recommend that GYN oncologists use and that we feel like are the best developed for our patients. But despite that, administration of PROs in GYN oncology is not routine. And this is where I want everyone on the call to start thinking about, hmm, where can I do research on this, right? And GYN-onc specific PROs, the fact in the URTC system have not been updated since the 90s and we're gonna talk about that in a minute. A national survey to all the GYN oncologists in the United States showed that really less than 10% of GYN oncologists use PROs in routine clinical care. And of those who did, up to a quarter of them thought they were using PROs, but really they were just kind of using their own made up questionnaires, right? And as I established before, you can't just make up your own questionnaire. You don't know if they can adequately test what you want. And barriers to clinical use include time, electronic health record integration, figuring out, it's daunting, what's the right PROM to use? And really ensuring that the PROM is useful to patients and physicians. This is a time of culture change and paradigm shift, right? The most common complaint or drawback I hear from physicians is I don't know what to do with the PROM, right? I don't know what to do if they flag positive. And it's hard to convince people that you should just act pragmatically, right? You should do what you would do if someone told you that they had terrible neuropathy or someone told you that they had terrible belly pain. Proposed to be routine in places with electronic medical record, you really need to engage three parties. And I think this is similar to when Dr. Brand earlier was talking about collaborating, right? They have to work for the patients, they have to be useful, they can't be offensive, right? In our field, there's a lot of interest in sort of sexual function, but some patients find that offensive, right? So you have to be thoughtful about that. Are the patients able to get anything out of the PROs? Does their doctor actually reference that they looked at the PROs? Are they able, the highest demand feature, which we still don't have, is can a patient fill out PROs and immediately get some feedback that shows where they are with patients like them on the curve, right? And then, sorry, the PROs have to reach them in ways that are convenient. We do via tablet and patient portal. Again, you could put it on a clipboard with a piece of paper. It doesn't matter, it just needs to be convenient and easy. One of the issues I wanna highlight, and this is my current area of research interest, and I think it's a huge field, it's completely nascent and can use all sorts of bright minds to work in it, is that current PROMs content validity has not been updated since the 1990s. So let's talk a minute about content validity. So content validity refers to the ability of your PROM to test what it wants to test, okay? And culture changes, treatments change, people change, how we talk to each other changes. And so generally, most PROMs need to be updated pretty routinely, right? And how that would work is you take a PROM, a group of psychometricians would go and test that PROM in focus groups to say, if you wanted to say you were tired, is this how you would say it, right? Is this an adequate representation? Is there a way we could say it better? And for all of our PROs and GYN guys, we haven't updated the content validity since the 90s. And as we all know, ovarian cancer itself is the same, right, so some constructs should be fine, like belly pain, but others have changed profoundly. Like this is platinum era sort of stuff, right? It doesn't take into account any of our newer drugs, newer treatment protocols, the effects of IMRT, like a lot of the old radiation questionnaires look like old radiation questionnaires. And it also, they often don't reflect sort of the cultural nuances that now exist. Now, almost 30 years later, you know, one of the things I always highlight is that on the fact of, right, I highlighted this question that says, I am able to feel like a woman. So when we get qualitative interviewing in our own clinic, women consistently highlighted this question as feeling offensive to them. Now, it's obvious that in the 90s, what they were trying to get at was, did your treatment impact your body image, right? Or impact your ability to feel sexually comfortable, right? But many patients today just find, frankly, the way that that's phrased offensive, right? In a more gender fluid sort of sexuality, non-fluid, non-binary sort of world, right? A lot of women say, what does that mean to feel like a woman? Like, what are you insinuating? And so that's an example that I use it in the 90s might've been very appropriate, but now the last thing you wanna do is offend the patients, right, or not be inclusive of patients. And the other big concern that I have is that current PROs generally do not represent non-white affluent patients. And this is something that is a huge problem in the field. The literature is rife with the fact that the way you would say something from one country to another, for example, is not the same way, right? A classic example is for the promise physical function upper arm. In the United States, there's a line that says, I am able to pass the Thanksgiving turkey around the table, right? Well, we are the only people that celebrate Thanksgiving. That doesn't make sense in other countries. And there are similar sort of ways of asking something that frankly aren't relevant, right, to other people. In addition, we know that there's very clear data that based on self-identified race and ethnicity, things might be said differently. And right now, our current PROs are very exclusionary of anyone but white affluent patients. Most PROs, and here I'm gonna use example of the EORTC OP28, the domains that are in it, the things they wanted to test, belly pain, nausea, anxiety, those were developed within randomized clinical trials that were done in the 90s. Now, work by Scalici et al shows that clinical trials in 2005 and 2014 had observed black patient enrollment 15 fold lower than it should have been based on population levels, right? And so automatically, you know black women as a group, for example, are gonna be underrepresented in this work, right? Furthermore, if you look at this particular scale, which is one of the primary ones used in ovarian cancer, 50 issues were derived and they had relevance testing in five countries, right? And then this list was then administered to 82 cancer patients in the same countries. And if you look at the table one, they do not even comment on race and socioeconomic status as covariates, right? And ideally, it would even be self-reported race. The next validation occurred in Scott Rock trial patients. Again, race and socioeconomic status not included. And finally, international validation occurred and we didn't even track if it was a heterogeneous group of women who represented a wide variety of different race, racial and ethnic and cultural backgrounds. This is another one from the international validation study, the table one. Again, you can see here, right? We looked at cohabitation status and age, didn't look at much else. And we know that people may say things differently and how can you know if you don't check? And so where are the current research opportunities and problems? Well, hopefully I just laid out two, right? The content validity of PROs, as well as the fact that PROs as they currently exist were really built in what I would call an exclusionary way, focusing on clinical trial candidates of a relatively homogenous group. And there are just so many other options to do research with PROs. One of my passions is the content validity and ensuring adequate race, socioeconomic status, gender construction, or excuse me, gender constructs in these. We want our PROs to be inclusive, right? Of everyone, it's really sort of the antithesis of patient reported outcomes to make them exclusionary to subsets of our patients. Clinical trial and PROs for novel therapeutics, we don't have a single PRO that exists for patients with ovarian cancer or any other cancer that reflects drugs past the platinum era, period. What are the long-term PROs as it relates to PARC maintenance therapy, right? This would be an amazing study. As we all know, the quality of life studies and all of the randomized clinical trials with PARP inhibitors were short, right? Quality of life. If we are using a new maintenance drug in a period of time that would otherwise be good, right? It is really important to assess the fact that it doesn't hurt quality of life in those women, right? We don't know the answer to that. What are the long-term PROs on PEMBRU? We don't know the answer to that, have no idea, right? Pragmatic real-world studies, describing PROs in routine clinical populations. That's currently what I'm doing. I've published a few papers and have submitted another one just literally describing what PROs look like in routine, heterogeneous, mixed-race sort of clinical populations as opposed to clinical trial populations. And the answers are really different. Generally, they're a lot lower in my clinic. Implementation science. How do I improve PRO collection, right? What are the barriers to docs? PCORI grants if you're in the United States. How do patients wanna see these? Do they want it shown as one of those lowest regressions I showed or bar charts or pie charts? What's the best way to get them to partner in this? Do PROs show that a particular treatment is valuable, right? And then cross-disciplinary and longitudinal studies. PROMs amongst various treatment modalities, partnering with your radiation oncology colleagues or surgical colleagues, chemo. PROMs in oncology and sexual dysfunction. PROMs in oncology before and after palliative care and so forth and so on. There's so many different opportunities. I put on the end of this, we can disseminate the slides, some of the examples of sort of just different research we've done with these here. This was a qualitative interviewing study that we did. This was our big scale implementation project. These were white papers, right? Where we made recommendations. This was one that's just a basic descriptor paper that I partnered with the orthopedists on. Again, we're not talking about orthopedics here, but just describing how mental health influences outcome. And this is one in just basic clinical statements around vulvar cancer. So there's lots of options and it's a nascent field, which is rare to walk into, but I think that anybody on this call would be well-served to sort of consider a research career in this field. Thank you so much for your time. I'll stop here. I'd like to thank Dr. Sisodia so much for giving that fantastic talk on PROMS. She's given us so many different ideas and ways that the Junior Research Network can be involved in research in this area and also use PROMS on a day-to-day basis in their clinic. It was fantastic. So we'll now open the floor to questions for both Dr. Sisodia and Dr. Brand. So please send your questions through the Q&A feature We have a number of questions already, which is great. I'm going to hand you over to the junior faculty, Navia and Gitu to pass on those questions to our panellists. And again, just to remind you to send through questions for the Q&A. Thank you. Okay, so Gitu or Navia, would you like to ask the first question? Yeah, this question comes from one of the attendees and Dr. Brand, the question is, are clinical trials only about drug and treatment studies or are there other kinds of clinical trials? Absolutely not. They're just about drugs. I'm a surgeon, so I'm really, really interested in surgical trials. And there's no doubt that the emphasis on clinical trials tends to be on drugs, but in Ansgog, our clinical trial group, we've got a number of surgical trials that are up and running. Rhonda is leading a surgical trial on intraperitoneal chemotherapy called Hinova. I'm doing a surgical trial on administration of ERAS protocols and how we might do that in our hospitals. So they're harder to get funded because there's no drug company willing to support a clinical trial. So that's a big issue in terms of funding. But I think the issue with surgery is that new surgical interventions or new ways of doing things surgically should be subjected to the same critical interventions and critical aspects that we do for drugs as well. So I'm really keen on doing surgical trials. Radiation is another area that we don't look at often enough. And again, the same reasons, there's not any drug involved and therefore you've got no drug company funding. But we shouldn't be doing trials just because we have drug company funding. I think it was John F. Kennedy who says, we shouldn't be doing things because they're easy, we should be doing things because they're hard. And I think that if it's really important, then it doesn't matter how hard it is, we should try and do it. Thank you. Thank you, Dr. Brand. I have a few questions for Dr. Rachel. The questions have been asked by Shamanik Bodhi. What validated prompts are available for gyne and gyne-oncology patients after surgery? That's the first question and there are some follow-up questions also. Can you go ahead with the first one? Sure, really the only options are gonna be the URTC and the FACT subscales. Those were all validated in women who had had surgery and then were undergoing subsequent treatment. So those would be your best bet. You could pull like promise physical function or promise abdominal pain, but those are not gonna be specific to patients with GYN-onc cancers. They're gonna just be a general belly pain survey. So if you're interested in the post-surgical course, I would stick with the FACT or the URTC system despite their limitations, which we discussed. Great. The follow-up question to that one is, how do you decide what to evaluate? Whatever you want, right? So whatever makes sense to you. In my questionnaire set that we asked, there was this JCO study, this great JCO study that showed that people that were married lived longer. I don't know if you all have read this. It was like back in 2011. And I always, there's a lot of interesting comments that can be made about that. It makes you wonder who they're married to. But irrespective of that, I wanted to look at how emotional and instrumental support affected our patient. So I asked promise emotional and instrumental support. It's totally fine. Ask whatever you're interested in, as long as there's a validated tool. And you shouldn't feel, you know, actually for that one, sorry, but just to expand on that, instrumental support was predictive. So if you didn't have someone who could take you to the doctor, actually you had a higher risk of having complications in our study. But emotional support turns out didn't matter. So I tested that for two years and then I got it out of our questionnaire set. Didn't matter, but who cares, right? You learn. Another question, Dr. Delvedia, how do you design new and applicable questions? So for example, ovarian cancer patients on PARPS or more inclusive questions that better reflect patients of all ethnic backgrounds and gender identities? Yeah, that's a great question. So it's hard to do. So I would say I'm gonna bucket that into two sets. So the first one, how do you develop like a PRO? It's tough to do. There's a whole field of psychometrics. You saw that example with the cleft Q. Really the standard for these goes up and up and up. And so most of us, speak to some of Dr. Brand's points, don't have the finances to do an international validation. That being said, updating content validity is not hard. And actually the SGO just partnered with a pharmaceutical company, for example, with FACT-N, which is our endometrial cancer scale. We're testing all these item constructs in a series of patients who identify as black and Hispanic, right, to see if they're still relevant and up to date. That can be done actually with relatively little sample size, literally like 20 to 30 people in focus groups. So it's not hard to do, but you do need to partner with a psychometrics group to do it. So we're actually partnering with the originators of the scale. Great, there was one more question. Do you have to get permission to use validated scales like the FSFI or other ones that are going to publish the data? No, there's a couple that you do, like the SF36, which is a general quality of life scale. There's a few others, but they're rare and you should stay away from them. And another great resource is PROMIS, P-R-O-M-I-S. They're validated tools that test over like 200 different constructs. And most of them are translated in up to 20 languages and you can get them online, use them for free. All of the United States is really moving towards PROMIS, but most you don't need to even outside of that. I have a question for Alison. So how do the junior members, so less than five years out, get involved, for example, with GCIG or CCRN if they have an idea? How practically would they then, I know you mentioned some ways before, go through their national trials group, but could you just run through that briefly again? Yep, I can do that. But can I just echo something that Dr. Sessodio said about how you get involved in this at the very basic level? And my involvement in clinical trials and GCIG went all the way back to doing exactly what she said, was she said, yes. And that's the best thing you can ever do is say yes. So I had been working and training in Canada where there was a longstanding clinical trials group. And I think I consented my first patient to a clinical trial when I was a resident in about 1990. And then I moved to Australia. And in 2000, I was shocked to find that there was no clinical trials group in Australia. And people that are well-known to all, I think that are on the webinar right now, Michael Quinn and Michael Freelander decided they were gonna set up ANZCOG. And Michael Freelander called me out of the blue, I don't think I'd even met him because I was very new to the country. And he said, Alison, will you become chair of our quality assurance committee for our new clinical trials group? And I said, Michael, I know nothing about quality assurance. And he said, doesn't matter, no one else does either. And so I said, yes, even though I had nothing, I knew nothing, but I was willing to learn. And it was a passion. That's the other thing you have to say yes, but you can't say yes, if you're not really interested, you have to have a passion about it. So I learned all I could about quality assurance and I became the quality assurance person for ANZCOG. And 12 years later, they asked me to be the chair. And even though I didn't think I was gonna be very good at it, I said, yes, and I put my heart and soul into it. So I think the first thing you do is do exactly what Rachel did is you say yes, and then you put your heart and soul into it and then great things can happen. But from a practical point of view about getting your trial, your great idea that you have thought about up and running is to first get the support from your collaborators in your hospital. And then it's gonna be the next big step is gonna be, do you have a national clinical trials group? And if you have a national clinical trials group, then your way forward is a little bit easier because you then will have to go through whatever that national clinical trials group hoops are to get it up front and going in your national group. And your national group will then decide whether or not they think it's suitable to take to the GCIG. So everything has to come to GCIG through a national group. That's how you get them up. And we have a meeting twice a year where ideas are presented and people are really presenting those ideas because they want support and they want other groups involved because we're going to just do a trial ourselves that it will take so much longer to do that if we don't have collaboration and so much quicker to do it with the results so much quicker if we have international collaboration. The GCIG highly recommends that each clinical trial group, national clinical trial group brings a young investigator to one of the six monthly meetings. And that's just really to expose everybody to what goes on at GCIG, but also to network because that's really, really important. You need to network your idea and you will get great feedback and great information from talking to other people about your idea. And so currently national groups are allowed to bring six participants to each GCIG meeting. And we encourage that one of those six people will be a junior investigator. There's not been an awful lot of good things that we can say about COVID-19 pandemic, but one of the good things about the COVID-19 pandemic is that we have learned how to do meetings with Zoom. And what that has meant for GCIG is that many, many more people can come to the meeting because we're no longer restricted to six people per clinical trials group. So I'm sure that's happened also with IGCS as well, but it's really been able to give everybody a bit of a taste to what GCIG is all about. And it's not the same networking. I mean, the networking is really important at GCIG and that's, I think, important with any group that you are partnered with, that you get involved with networking, but that's a little bit of a taster about how you can get involved. With CCRN, they do a number of workshops in developing countries, and that would be another good way to get involved with CCRN, which is perhaps a little bit easier to get your trial up and running with CCRN than with GCIG, although it has to be cervix related. Okay. Dr. Brand, can I follow up in a question of what you have just said? So from what I know, that if we want to participate in GCIG, we have to be, it has to have published therapeutic trials. So what is the definition of a published clinical trial? If a group has had experience in participating in pharmaceutical trials, but they don't have a PI on the list of authors, do you count that? Yes, and that's my question. Yeah, I'm not on the membership committee currently, although I suspect I will become on the membership committee when I become chair. And so I think there had to be some rules and regulations around who could become a member. And what we're really looking for to become a member is that the group has some experience in doing clinical trials. And obviously the objective assessment of that would be a publication as a result of a clinical trial that you have conducted. But I think that if you've got a group that's been involved in clinical trials, and if you can demonstrate that you've got the infrastructure available to do clinical trials, then I would encourage you to submit an application to the membership committee. It's never gonna be completely black and white. And if there are some areas in which you might be lacking in terms of the requirements for members, the GCIG would be very happy to help you overcome those issues. Because we want people to be involved in clinical trials, and we know that developing countries are hugely unrepresented in clinical trials. Partly that's because they've not got the clinical trials up and running, but part of it also is because the clinical trials that we do in North America and in Europe and in Australia even are not necessarily the clinical trials that you guys might be interested in because you've got perhaps bigger fish to fry than what we do in terms of the treatments available to all your patients. So Australia and New Zealand Gynae Oncology Group are partnering with Asian groups too and have developed APGOT, which is a clinical trials group. And that's part of what we wanna do is we wanna make sure that the clinical trials that we develop and run have relevance to groups that are not necessarily North American, European and Australian. Thank you so much, Dr. Brand. The next question is for Dr. Sisodia. Anisa Maburu first says great presentation. Thank you again. And asks, how would you advise someone in a hospital in a low middle income country to go about establishing PROMs, especially someone in regular clinic practice with high volume and not a lot of time to do additional work outside of their clinical practice? Yeah, I think the best way to do it would be to do paper. And this is what we do in some of our high volume like community outreach centers, right? Where people are strapped for resources, don't have a lot of time. Choose one instrument that matters, do it on paper and just hand it to them on the old fashioned clinic clipboard that I am sure exists in every country in the world. It must, I don't know. And if I were gonna choose one for cancer patients, I would choose actually the FACT-G7 that's in that Society for Gynecologic Oncology white paper. The scales that I use are older ones, but the newer recommendation from SGO is to use this new tool that's distilled down into seven questions. You don't have to score it, you don't have to like do fancy math, you don't have to do anything and it gives you a really robust understanding of where the patient is and how they're doing. You can do it in less than a minute. Dr. Brand, there's a question. Can an individual interested in cervical cancer research and clinical trial join CCRM and how? I'm unmuted now. So what you would need to do is your site would need to want to join. Now, presumably if you're at a hospital, then you've got colleagues at the hospital who might want to look at doing clinical trials. At an absolute minimum, you need to have some infrastructure at your site that will allow you to do clinical trials. And in my presentation, I talked about the sort of stuff that you would need to do because we do need to know that the data that is collected for any clinical trial is valid and accurate and appropriate. So, because otherwise the validity of the trial will be in question and we don't really want that in the end. And then it's a matter of seeing whether or not the trials that are up and running with CCRM are of interest to you. Or conversely, seeing whether or not you have an idea that might be of interest to CCRM. And as we've emphasized, as Rachel and I have both emphasized, is collaboration is the key. You cannot think that your one great idea is necessarily gonna be something that you can run with by yourself. You can't. You'd be exhausted trying to get it up and running. And one of the things that you really need to have is resilience when people reject your fantastic idea and say, well, you could have done this, you could have done that, you could have done the other. So one of the ways to avoid all of that is to actually get a lot of opinions from everybody about your great idea and refine it. And then the idea is to approach CCRM. And the current chair of CCRM is Marie Plant from Canada. And again, I'm not 100% familiar with the requirements for that, but certainly she would be able to, or contacting her through GCIG would be a way of getting interested and seeing how you can get involved with CCRM. Thank you, Dr. Brand. A follow-up question to that from Christophe Millian. What are some valuable ways that you found to finance trials in resource-poor settings? Ah, the issue of money. Oh my goodness. If only we didn't have to worry about money, how easy life would be. And the problem is that whilst getting funding for trials is a hell of a lot of easier in developed countries, it's still not easy in developed countries. So I've just spent about the last two months trying to do a grant application for a clinical trial that I want to run here. And I will have to put that grant application in, and then I will probably have a maybe 5% chance of getting any money because I'm up against all comers, not just cancer patients. So, and I think in low and middle income countries, the obstacles are even greater. So we in ANZCOG, we apply to government funders, which you may or may not have access to at all in low and middle income countries. We then also apply to philanthropic organizations, and that might be a better bet for low and middle income countries. When I first set up the clinical trials unit at my individual hospital, we had received a bequest from a patient, and we used that money to fund a clinical trials coordinator and then from there, we're able to self-fund her on the basis of pharmaceutical trials. And so then that brings up the whole issue of pharmaceutical trials and using them to fund your trials. There's pros and cons to that. So the pros of all of that obviously is the pharmaceutical companies will likely fund at least part, if not all. The other problem with that is you have to do the trials that the pharmaceutical companies want to do. And that is if you want to do surgical trials or if you want to do radiation trials, then of course that's not going to help you at all. If you want to do pharmaceutical trials and you want to test drugs, then it has to be the drugs that they want you to test. And in some ways that can be selling your soul to the devil. On the other hand, it could get you a toe in the door. So funding is a problem, and those are probably the three ways you get it, i.e. pharmaceuticals, philanthropic or government funding or donations. So, hi, Dr. Cecilia, a question from the attendee and from Dr. Kudos-Lawal. Why are there no PROM for GTD? What do you think is the answer? Would you suggest anything for people who are interested in GTD to start a prom? Yeah, it's a great question. So my suspicion is it because there's not a ton of GTD in the United States. I think most PROs are developed here. And hopefully we cure people quickly, right? So there's not like this long latency period where you're following PROs over time. That being said, again, just kind of hammering that point home, just choose something pragmatic from the menu that makes sense for those patients. So having taken care of some GTD patients, right? Like while you're giving them treatment, you might wanna ask about nausea and things like that, but that's not particularly necessarily compelling. I think a really cool research question those patients would be using PROs looking at support at home, like relationships with partners, right? That stuff gets really tricky during this time. Anxiety, depression, concerns about further fertility, that FSFI, the Female Sexual Function Index, any of those things would be fascinating, candidly. So I would recommend that, but there are not any that are dedicated specifically to GTN, but I think it also hits, I saw a question in the regular chat, which is that can a PROM be from a clinical research used to be used apart from a clinical trial? Absolutely, right? Absolutely. So there's PROMs that are dedicated just to a disease site, ovarian cancer, cervical cancer, right? Those can be used anywhere, but have to be used for those diseases. But then the other ones would be ones that are dedicated to a certain problem, anxiety, depression, belly pain, nausea, and you could use those ubiquitously. Thank you so much. And thank you, Drs. Brand and Sisodia for presenting today. And thank you to all of our junior- Thank you so much, Dr. Sisodia. I wanna thank all of our speakers and thank you all for attending. We will, a few notes before we close the meeting for today. Let me share my screen. There we go. Today's session was recorded. So IGCS members will have access to the recording via the education portal early next week. We welcome you to join the IGCS Early Career Network. And we are starting a Facebook group. So we welcome you all to join that private Facebook group where we can continue having these really important discussions. One valuable resource we wanna highlight quickly is the Ask a Pathologist feature that's available to IGCS members. As you all know, oncologists often rely heavily on their pathologist to accurately diagnose their patients but there is a critical shortage of pathologists in many parts of the world. If you are an IGCS member and have a pathology related question, you can email pathology at igcs.org and answers will be provided by members of the IGCS pathology work group. Please visit our education portal for more details. Wishing you all continued health and safety and we're gonna sign off now. Take care. Thank you.

clinical trials

patient reported outcomes

PROs

IGCS education portal

Dr. Allison Brand

Dr. Rachel Sisodia

Dr. Rhonda Farrell

validated PROMs

quality of life

gynecologic oncology

PROMIS

inclusivity