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2021 Annual Global Meeting: Virtual
Plenary III: Presidential Plenary
Plenary III: Presidential Plenary
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Well, hello, everyone. So glad that you could join us today for day two. I hope you had a fantastic day one. And if you're new to the platform today, welcome. Please check it out. We have lots of cool things in the platform. And it's my pleasure to address you today as the current president of IGCS. Let me go ahead and share my slides here. Well, as I open this address, all I can say is, wow, what a year. In many parts of the world where baseball is popular, you probably won't have any difficulty in understanding the analogy of this year's trajectory to that of a professionally thrown breaking ball, arguably one of the most difficult pitches to not only throw well, but also address properly at the plate. This year, gave us no shortage of Lance McCullough style curveballs, including the one we had addressed not more than four weeks ago. But we are resilient organization, and one that was truly professional talent to navigate the changes in events. In this case, to carry the analogy forward to knock it out of the park. Remember last year when we went through the same exercise, where we onboarded a completely new technology largely unproven and for an international meeting with international attendees. Well, this solution melded live streaming research educational programs as well as provided access on demand to surgical films. We also provided content from our sponsors within a digital ecosystem leverage across the globe in multiple time zones. It was a huge success, particularly in light of the unknowns, and the stumbles that others had experienced. In the absence of the lift it would take to repeat this effort, we were somewhat confident. Maybe I should say, hopeful, expecting that we wouldn't have to wholly repeat this exercise in 2021. And although there were many distractions over the last year such as well being a US President, converting to a more permanent work from home setting and trying to understand why there's any controversy in the coronavirus vaccination story. We were still hopeful that we would be together in Rome in 2021. Unfortunately, the coronavirus pandemic proved too difficult to navigate in time to allow us to reach our room destination, and once again, we had to pivot. While we had hopes to see the sites of historical Rome and visit this incredible convention center in person as well see each of you in person. We set course to keep the meeting whole from a content perspective, while providing new enhancements to the digital platform to help bring us together to share our knowledge, our experience, and our research findings. The digital interface in this year's program is more engaging more robust and stable, and I encourage you to not only visit the many components of the website, but also take advantage of the social media opportunities promote the meeting and its findings, and many of you have already done so. Following the first day session. I'm so honored to serve this organization which has for almost 35 years, brought together an international audience to share educate collaborate and advocate for the betterment of women affected with gynecologic cancers. This is the current global footprint of the attendees to the 2021 meeting. I mean look at this is amazing from all over the world. I joined I GCS the year after my fellowship ended and attended my first meeting in Philadelphia 1995. I became inspired with the organization's internationally aligned mission and vision, particularly as it not only focused on problems shared globally, but also the recognition that solutions would entail creative, but likely different likely different tactics and strategies. It was also a unique opportunity to explore international collaboration where I was fortunate to make a number of contacts that have grown its robust collaborations and deep friendships that are persistent. Being part of the organization's governance provided unique opportunities for mentorship and strategic thinking inclusivity and collaboration. I'm truly grateful for the leadership of our past and current organizational staff, the council members, the all who have set the organization on a path to more nimbly address and support initiatives that are impactful and relevant to our ever growing constituency. From the bottom of my heart. Thank you. Thank you. Thank you for this opportunity. So aligned with the sentiment, we felt it was necessary to provide a North Star if you will, to help galvanize our mission which is to enhance the care of women with gynecologic cancer worldwide through education, training, and public awareness. In this manner we want to double down on our commitment to foster global health equity so in January this year we published the I GCS global health equity statement, which you can find its entirety on the I GCS website. The statement was released to leave no doubt regarding our position on the topic, and to guide current and future programs with clear intention to emphasize the importance and the importance of and the commitment to this mindset we begin each of our I GCS council meetings, reading the statement to ensure that the intention is at the forefront of everything we do organizationally. I'll read some excerpts from it now. As a core principle, the concept of global health equity is embedded in the I GCS mission, and is reflected in the breadth of our membership and the design and implementation of our programs with over 3000 members from low middle and high income countries around the globe, I GCS has purposefully developed an inclusive membership framework that encourages interaction and growth across diverse political, social, and healthcare systems. Through this framework I just connect members with specific needs to those with corresponding resources and programs forums partnerships enhances benefits to women affected by gynecologic cancer is not only an optimal, but also in the most challenging circumstances and environments and educate trains and mentors clinicians and survivor patients and caregivers. With that in mind, I'd like to present you to use some of the I GCS programs and partnerships that especially embody our commitment to address disparities in education mentorship and care around the world. Now I know I don't have to convince the attendees of this conference that the global burden of cancer is significant and increasing new cases are expected to nearly double in the next two decades. For instance rates are shared and consistent within countries, the impact of premature death due to cancer is disproportionately carried by under resourced settings and is expected to continue to fall off initiative based targets over the next decade, ever increasing the accentuating health disparity. For instance cervix cancer is diagnosed all over the world, just obey it at heterogeneous rates. However, the burden of mortality disproportionately affects low resource settings, a stigma that is truly tragic, given this disease has the potential of being completely preventable. One of the things that I'm passionate about and so glad that we're beginning to address in society is disparity and inequity of care for variant cancer patients particularly surgical management, and separately the need for genetic testing globally. As we know there have been multiple reports demonstrating glaring local and regional variations on the standard of cytoreductive surgery for advanced ovarian cancer patients. I guess believes that there is an important opportunity to bring global, the global oncology and surgical oncology community together to implement change for women with ovarian cancer globally. With respect to our proposed genetics project. We now, we, we know in recent years the clinical implications of genetic testing ovarian cancer has gained in significance not only for surveillance and surgical prevention but also for therapeutic decision making. Many of which have been highlighted at this year's meeting. However, despite technological advances, low income countries still lack quality screening tools, genetic counseling, and public policies to address this testing, which has significantly impacted treatment decisions and outcomes. For this reason, reason, and in concert with our health equity statement IGCS has chosen to do a patient centered demonstration project, aiming to improve the risk assessment and low income countries by providing access to VRCA and HRD testing, counseling, and treatment options for ovarian cancer patients. Now as far as education, and as being witnessed this week and disseminated widely in social media education is our passion and a key pillar of our mission. We have initiated two robust certificate programs that provide discipline specific content in a condensed format. Our certificate programs have the goal to fill gaps in existing knowledge, and to keep our members current. One is palliative medicine, and the other is pre invasive cervical disease management, which provides the framework for basic training in a pre invasive disease to those clinicians and providers in LMICs that do not have such training programs. However, in recognition of knowledge gaps and heterogeneous practices patterns in radiation oncology, we expanded the content of our popular tumor boards to include a focus on radiation oncology. This effort is provided to be an efficient mechanism to establish new collaborations, as well as addressing the knowledge deficits via clinically relevant case based tumor boards. This slide shows our mentoring and training programs at work. One very impactful way to help with care inequities and address gaps in global health is training physicians in regions around the world that do not have formal training in gynecologic oncology. The aim is to help develop gynecologic expertise locally and to meet the specific needs of each site and region. Truly a capacity building initiative over the last four years IGCS is investing in the effectiveness and future sustainability of each of these individual training programs. Our international team of volunteer mentors work with the local faculty and fellows at each participation institution to adapt the basic toolkit and build the capacity to provide surgical and medical care, participate in research and provide education related to gynecologic cancers. As of today we have 16 fellows who have successfully completed the program from all over the globe, Ethiopia, Guatemala, Kenya, Mozambique, Nepal, Qatar, Uganda, Vietnam. We are continually working on improving the programs to meet the needs on the ground. In this slide you'll note the logo from the International Society of Gynecologic Pathologists or ISGIP. We partnered with ISGIP to help develop a framework to standardize assessment and documentation of pathology reports. The intent of this affiliation is to harmonize key decision making information across the spectrum of resource settings. And finally advocacy. Organizationally we have been known for years for our collaboration with various advocacy groups around the world, and have recently enhanced our own internal resources to continue this mission. In this way we have recently joined with the World Ovarian Cancer Coalition as a strategic advocacy partner to launch a number of specific initiatives to improve survival and quality of life for women with diagnosed with ovarian cancer. An exciting effort called the Every Woman Study Low and Middle Income Edition will launch during the inaugural global partner meeting at the end of next month. This study is designed to evaluate and compare outcomes between other low and middle income countries at a regional and national level. And we are super excited about partnering with this mission initiative. We also have formed an alliance to continue the great work of Globathon. Some of you may still have your Globathon towels. We are taking this on, which we hope will continue to build a powerful global network. We will also host annual patient summits and roundtables to discuss issues and find solutions in health disparities. So let me please extend my warm thank you to all who have been involved in these programs. It's an incredible labor of love, and we're seeing the fruits of this tremendous effort. But as you can see, it's been a busy year. And I would be remiss if I didn't acknowledge and thank my amazing and, as you can see, expanding family. Intolerating all the closed doors like I'm having right now, late night, early morning conference calls and support that has enabled my participation in this aggressive agenda. Now, to those of you who have heard me give a talk on research, you'll recognize this slide. I use it a lot, and I believe it wholeheartedly. It is really what drives me and my passion for gynecologic oncology. Research is truly how we make a difference in care. Establish the new standards, and move the needle. In fact, I believe it's our responsibility. Here are just a few of the publications that have helped to shape our current clinical environment. These have come from strategic development, execution of clinical trials, and testing new approaches to care to include patients from all over the world in many different resource settings. Many of the authors of these trials are actually listening in right now. These practice-changing efforts could only be accomplished in the context of true collaboration. So it is with this context that I am so excited to moderate a discussion of four international clinical trial organizations that are at the forefront of developing these future standards of care. These groups operate through global partnerships and emulate so much of how IGCS operates today, day in and day out, through the success of partnerships and international collaboration. The leaders of these organizations today will share their viewpoints on successful collaboration and highlight clinical research that has transformed standard of care. I'm honored and humbled to moderate this session, which includes my friends and dear colleagues, such as Professor Marie Blant, a gynecologic oncologist in Quebec. She serves as chair and is representing the CCRN, which is the Clinical Cervical Cancer Research Network. Professor Alison Brand, who is director of the Department of Gynecologic Oncology in the University of Sydney in Australia. She joins us locally from there in her role as chair-elect of the GCIG, which is the Gynecologic Cancer Intergroup. Professor Tom Herzog from the University of Cincinnati, who is deputy director of the University of Cincinnati Conference of Cancer Center and vice chair of quality and safety for the Department of Obstetrics and Gynecology. And Tom today is representing GOG Foundation, where he serves as treasurer and the Gynecologic Oncology Group partners, where he is an associate director. And Professor Mencer Mirza, who is the chief oncologist and of the Department of Oncology in Riggs Hospitalet in Copenhagen. He is also the director of the Nordic Society of Gynecologic Oncology, the NSGO. And he is representing today as chair of the European Network of Gynecologic Oncology Trialist Groups, or NGOT. So thanks to you all for joining me today and for sharing your thoughts on how international collaboration has and can be a key to success in clinical trial conduct. So let me bring everybody back to the table here, virtual table, and I'll start off. Make sure you guys unmute because I don't hear any other noise. Let's get you guys together. Okay, so let me start out with you, Marie. Maybe you could tell us a little about the mission and vision of the CCRN. Yes. Well, first, Rob, thank you for inviting me to be part of this panel discussion. It's really an awesome situation. I happen to be the chair of the Cervical Cancer Research Network, and as you alluded to in your presentation, well over 90% of cervical cancer occur in LMICs and yet very little research is conducted there, which frankly is an aberration. So it's to address this particular disparity between where cancer occurs and where research is conducted that Professor Henry Kitchener, back in 2011, wanted to develop the CCRN to address this issue. And he actually wanted to develop a network of centers from LMICs with interest and expertise in research with the idea to engage LMICs in research to raise the standards of research and to also address their own issues with regards to diversity and equity. So that's how the whole story started. So that's been 10 years now. 10 years. Awesome. Awesome. Fantastic. And Allison, maybe you could tell us a little about what is the GCIG? I know we talk about it, we use that acronym frequently, but I'm just curious as, you know, maybe for people who aren't familiar necessarily with what GCIG is, maybe you could explain a little bit about what the structure is and why it was put together. Sorry. Thanks very much for inviting me to come. I'm standing in for Amit Oza, who's the current chair of GCIG, but he's on holiday somewhere in the wilds of Canada having a very nice time, I imagine. So GCIG is the Gynae Cancer Intergroup, and the mission of the group is to promote and facilitate high quality trials in gynecologic cancer. And it really came about in the late 70s with a collaboration between some European groups and the Canadian groups as a way to conduct clinical trials in a more efficient manner, really. And it was the success of those early collaborations that really led to the establishment of the group in the late 90s, early 2000s. And really now it's an umbrella organisation of about 33 national and in some cases international groups like ANZGROG, which is Australia and New Zealand, two separate countries, but mostly national groups that come together to collaborate on clinical trials. There's been an emphasis to some degree on academic and investigator initiated trials, certainly at the very beginning, there was almost a whole, completely emphasis on that. But I think we all recognise that the landscape of clinical trials has changed somewhat in the last few years with targeted therapies and the need to broaden our impact by broadening how we do clinical trials. So there's been a broadening of our scope in that, but still the emphasis is on good quality clinical trials. And whilst some trials are obviously need the impact the input of industry or pharmaceutical companies, there are many trials such as surgical trials or radiotherapy trials or symptom benefit trials or quality of life trials that need to be done that don't have that emphasis. And so GCIG basically takes all comers and has a broad reach in terms of the clinical trials that it wants to do. So it's kind of like a gathering place where different organizations can bring their trials to share what's available, what's going on and potentially engage some participation. Yeah, I think what I like to say is that there's an efficiency with collaboration. You know, if say me in a small country of just 25 million people have a great idea, there's no way in Australia I'm gonna be able to do a study like Outback. We need collaboration from other countries and that's how Outback started and how it became such a successful trial is because we brought it to GCIG and the results speak for themselves. So I think that's the beauty in many ways of GCIG is that any group, no matter how big or how small can bring a great idea to the table and potentially have it adopted as a GCIG trial which then allows it to be completed in a much more efficient and timely manner than would be able to be done if you just kept it in a single country. Right, and that's literally the theme of what we're talking about here is how do we collaborate internationally to increase the throughput of ideas? And Mansur, you know, NGOT has been a part of, I think the GCIG from pretty much the very beginning. Maybe you could just explain to the audience what NGOT is and maybe tell us a little bit about why it was put together and what it does. Oh, thanks, thanks. First of all, thanks, Rob, for inviting. It's an honor and pleasure to be among friends. Well, what we felt was although we were all very much involved in GCIG, actually NSGO together with, as Alison said, the NCIC and other MRC, NURTC, we established GCIG many years ago. We felt that not all the countries were able to be involved within Europe. And we felt that we needed some organizations stronger in Europe, which could bring clinical research to each and every patient and enabling every patient in every European country to access clinical trial. And it's quite interesting. And it is five, the IGCS was established in Berlin. And in 2007, we established in the same city, NGOT. So we are only 14 years and we are now have finished or running or starting 114 clinical trials. And the strength is that we are not alone in Europe. We, as you will hear from my friend, Tom, in a moment and you, Rob, you know, we are involved that we do trials together. I think Alison's put it very nicely that 25 million in Australia, and if you had to do an outback only in Australia, it will take decades. Now, in cases, even we should not do things alone. We can do it much better together. So that's why we have this amazing collaboration within Europe, 21 groups, 25 countries. On top of that, we have great collaboration with GOG, with the Canadians, with others. And then we are very much a solid part of the international society for the rest of the world through the GCIG. So I think together, we have really established and you showed some of the publications, late publications. These trials are being run through the collaboration and that's why we can change the standard of care so fast. Cancer now in endometrial as well, and you saw the IO trials, you will see more coming. So I think we have really, I think we are blessed in gyne oncology. I don't know any other disease group who work so close to each other. On international scale, yeah. Yeah, it didn't take me long to put that slide together. And I just picked the Journal of Medicine, not only because it's a prominent journal, but because those are basically practice changing trials. And the recent years, that's just recently. So, and there are many other practice changing trials that have obviously been published, but yeah, you hit it right on the head. I think we have, this is the fruit of international collaboration because the throughput is high and the impact is high and the relevance is high. So, you know, so NGAT is, you know, kind of a, it looks like a connected group of cooperative groups, a group of groups. And so maybe, yeah. Actually, we are trying to help the countries where they didn't have a group to develop the group. We helped Israel to develop ISGO, we, the Polish group, the East European SIGOG, and now we are mentoring the Rusco, the Russian group to, you know, to work together. And I think this is the strength, working together, being organized, that makes us really strong. And the relationship we have with, the great relationship with GOG, that's really fruitful. Well, let me pivot to Tom and maybe you could bring us together on this. You know, NGAT is a group of groups in GOG, Gynecologic Oncology Group, in its tradition was the collection of multiple sites under a single cooperative group. So a little kind of an opposite approach, but, you know, this group obviously formed out of the legacy Gynecologic Oncology Group and now is called GOG Foundation. Tom, maybe tell us a little bit about, you know, what the GOG Foundation is, what's GOG Partners, and then kind of close up with how that relationship has been fostered with the NGAT-GOG collaboration. Sure, Rob, thank you so much for having me. First of all, I'm sitting in for Larry Copeland who probably isn't on holiday, he's probably in the operating room. True. I'm running to the OR, I hear myself here in a few minutes. So it's all good. Great question, it's interesting, right? Because there's so many external and internal forces that can create the formation of these groups and what the structure actually becomes. And in the fact of GOG Foundation, it really, you know, the GOG, as you said, the legacy group started in 1970, you go all the way back to that time and really grew and was very efficient in fact, of all the cooperative groups through the federal side was actually the most successful, interestingly, in terms of the percent enrollment of active patients that we had. So really amazing group, but the government decided that that wasn't good enough. So they wanted to leverage the cooperative groups together. So early to mid last decade, around 2014, they established GOG Foundation. And GOG Foundation is a program under which GOG partners exist. And I'll explain what that is in a second. And then obviously NRG oncology is there, and that's the G in the NRG portion of it that's under the foundation, needs to be understood. So the N represents the amalgamation of the federal groups that was mandated by the NCI. So the N was the National Surgical Adjuvant Breast and Bowel Project. The R in that acronym is the Radiation Therapy Oncology Group. And then the G is the legacy GOG, if that makes sense. And I know this is confusing as can be, it has to be confusing to people in other parts of the world because people in our own organization don't even know exactly. I had an energy meeting, a GOG partners meeting or what the rest of the foundation. So anyway, yeah, so GOG Foundation is really the organizational umbrella in which the G of NRG sits. So our federal side that does NCI related trials. And then GOG Partners is also a program under that. And the foundation itself is a nonprofit 501C3 with purpose of promoting excellence and quality and integrity of clinical and basic science research in our field. GOG Partners operates outside the federal part of this and really function as a site management organization providing additional platform for clinical trial development, mentorship opportunities, patient accrual, site infrastructure. And a lot of this is working through pharma and bringing drugs to registration. So we've been very successful in the past seven years or so with many, many new approvals. And so we're very proud of that. And I think finally, the thing that's really great that the partners have been set up purposefully to work with pharma, but really with the goal of filling the void of bringing trials to our sites, they're gonna lead to new agents for our patients. That's really been the big goal. And I think we've been very successful with that. And it's been really exciting. One of the things, this is all about collaboration and communication. And that is that we noticed that especially with pharma and especially with clinical trial ideas, our biggest asset, of course, is our patients. And we saw the days of, you know, GOG 111 and GOG 158, and then we have to do the exact same study across the pond in Europe. And we realized that by forming an alliance with NGOT, so we actually have a committee that we go through the trials and we try to as much as possible work together where that's politically feasible. And I think that's been very successful. So it's been a great three to five years here in which we've seen tremendous change in the clinical trial landscape and our ability to cooperate globally, which has been really satisfying. Yeah, you make a great point there, Tom, about the efficiency of not having to do repeated trials in different regulatory environments. I think our own FDA and the European societies, as well as through the RTOR project with being able to incorporate multiple countries with simultaneous approvals has really helped with this. But I wanna get back, Marie, maybe talk a little bit about funding because you represent CCRN and funding is, I know has been a struggle there. I will say that the science has started to broaden our ability to do innovative studies in multiple disciplines. It's not all about ovary anymore. So it took us a while to break into the endometrial space. Now we have a robust endometrial program. And then of course, with the identification of immunotherapy, it's now, and antibody drug conjugates, it's now expanding in the cervix cancer, but funding has always been a struggle there, always. And your effort, your mission, is to conduct impactful research in cervical cancer around the world. So I'm curious as to how do you navigate the funding issues there? Because it's oftentimes very difficult. Yeah, it is difficult. As you know, most of CCRN trials and many GCIG trials are investigator initiated trials or academic trials. And by definition, they're not typically funded by the industry or pharma. And so in order to fund those trials and surgical trials, in particular, classic, not academic trials, and to fund those trials, we typically have to run for grants, very competitive, difficult to get. And if you're ever successful to get the grant, the amount of money you get is barely enough to do trial development and trial coordination in such a way that all other centers and groups wanting to participate to that trial also have to find their funding, which takes a lot of time and delays development and approval. And the majority, and that's the problem, the majority of the LMIC centers simply do not have money to fund trials. So they cannot, even if they wanted, they're not able to participate in our research trials, which is really a shame. And it would be helpful if we could find ways to help them being able to participate. And I thought of a few ideas, but one of them is I think if we were more successful in bridging with the pharma or industry or large groups like Partners and NGOT, to do pharma trials in LMIC to generate income and money. And in turn, these centers could use that money to participate in academic trials, I think would be one way to help. Or perhaps pharma or large co-operative groups like NGOT again and Partners could have a proportion of their trials in their portfolio and as their mandate to support investigator. Yeah, that's here initially. That would be also very helpful. And I don't know if I could track back for just a second, but over the last 10 years, we've developed a very rich network of well over 30 sites, LMIC sites, North America, South Africa, South Asia, South America. And these centers to be badged CCRN have to fulfill a great deal of characteristics. They have to have good radiation therapy. They have to have medical oncologists. We now have data on those sites with data banking, tumor banking and immune therapy. They have to have well-trained gynecologic oncologists. They have to have a sponsorship from their institution to support trials. In addition, we used to do site visits to make sure everything's fine and the quality assurance is ensured, which is key quality assurance. And I guess what I wanna say is to the industry, perhaps listening to us into co-operative groups here present is that there is an immense potential, research potential and benefit in linking with LMIC sites to do research and they can do it. And as opposed to taking like six years to do Outback or SHAPE or other trials, it could be two to three years. So I really think that there's gonna be a benefit in working together more effectively. Alison, you had mentioned also investigator-initiated trials and I'll try to get through to Minster and to Tom as well. But I think investigator-initiated trials kind of has been a core principle of the portfolio of GCIG trials, at least in the initial, and obviously it's expanding now with more pharmacies. So you mentioned that the GCIG was kind of a home for where ideas could be brought and developed no matter how big of a group you were, you always had a voice. And I think that's really super important. Maybe you could tell us a little bit about how you navigate the IIT for somebody who's out there listening, who has an idea and doesn't know where to point. Can maybe you could tell us a little about the process of bringing those kind of trials forward? So, I mean, I guess one of the issues is that the process for GCIG is that the members are not individual people, the members are a cooperative trials group. So in many ways, that's the first hurdle that people have to get over is that they have to actually have a clinical trials group that they belong to. And in many ways, that's the way CCRN and GCIG, in many ways, we're hoping to interdigitate because for lower middle income countries, one of their ways to get their runs on a board, which is what they have to do, is to do a trial within CCRN and that's one way to do it. So once you have a cooperative group that you're a member of as an individual, then those groups apply to become members of GCIG. And there's a process to go through and there's a, you're probational for a while, usually just two years while you get the hang of things. And then we have meetings twice a year and really the meetings are working meetings, they're not huge meetings, they're limited to about six members from each group, which seems harsh for everybody that wants to come, but it's because you want to get, you wanna have it a working group where people can get together and talk about individual ideas. And I think that's the real key about these twice yearly meetings that we have is you really get a small group that can get together and there's a chance to network and talk about your ideas and get feedback on your ideas. And one of the benefits of COVID really is that we've had virtual meetings, which meant we haven't had to limit the number of people that come to our meetings. And that's really, I think opened the meetings up to lots of other members to see exactly what's going on. Cause it always sort of seemed a little bit when you were on the outside and hadn't been to a meeting that, oh, it's kind of secret women's or men's business and what's going on there. So I think that's been a real plus of COVID, but they are working meetings and you get to present your ideas and then people get to offer suggestions or critiques or whatever. And it's incredibly helpful to have, really smart people in the audience critique your idea and it can only benefit. And then you get people that then say, well, that's a really good idea. And our group would like to join in with you. And before you know, you've got five or six groups that want to help run the trial. The big thing about, which I think all of the groups would know about is the whole business about every country has different rules and regulations about how clinical trials are run. And one of the biggest and most important groups, committees in GCIG is what we call the harmonization group. And it's an incredibly hardworking group, which is mainly consists of trial coordinators and other and statisticians who really work out how we can run trials across different groups and different jurisdictions. And that's been an incredibly useful thing to do because as clinicians, we often say, well, we've got this great idea. We think this is how you should do the trial. And then we hand it over to our trial coordinators and our HRECs and all that sort of stuff. And you figure it out how we'll do it. So the harmonization group is a really important part of making sure that we can do trials across jurisdictions. Oh, okay. Yeah, I hadn't realized that's what the function of that group was. Now, Tom, the Gynecologic Oncology Group and its legacy format used to be all about IITs, right? We used to, everybody sat in that big room, sat on a committee. You had an idea, you put a proposal in there. It was usually trashed, but at least it was discussed for the most part. And then it got developed into a protocol. It was made it through the way and through the successful committees, et cetera. But now that we're under this new organization, what is the mechanism for people who wanna to provide an investigator initiated idea? I say that only because there are multiple different mechanisms and I don't think people really understand what they're supposed to do or what opportunities they have. So maybe you could maybe clarify a little bit about that. Yeah, I think the first thing is to really understand those two entry ports, right, into studies. So the NRG is sort of that traditional committee approach and now with a layer of a federal committee over that, that often the idea can get fairly well developed and even into a full protocol, and then it doesn't go anywhere after it doesn't clear that committee, which is being addressed, I think, in certain levels. And then on the GOG side, the GOG partner side, it's important to understand that we're opening up the opportunities for investigator initiated trials, but also if you have a great idea and you've already worked with a pharmaceutical company in terms of developing this idea into say an expanded phase 1B, and it looks like it's time to move to a registration type approach, that's the time to bring it to our group. And of course you would still be the shepherd for that. And we would acknowledge that by, in every case we've done so far, you would be the PI and run the steering committee and so forth. We're very inclusive. We want the best ideas to come to us and if you've got a great idea, contact any of us and we'll help develop it. Sounds great. And Mintsuri, you know, the Angad has had a mechanism for this for years in their model A and to some extent model B and C, you know, more focused on pharma based trials or traditional GOG partners types of trials. So tell us a little bit about, you know, how those, what's the process? Because you have multiple groups of groups. So how does that get vetted? Yeah, I think that's, and Marie, thanks for bringing it up. This is the most important part of Angad that the most relevant for academic clinical trials is that's where our highest priority, the translational research trials, the research on rare diseases where pharma may not be interested. So I think if you look at the statistics, more than half of the trials, 59 of the 114 trials are model A, as Rob just mentioned, that means that they are IITs. The sponsors are one of the clinical cooperative groups within the 21 countries. I can give you an example. When we started pushing that, now we need to get some more research in endometrial cancer, EN1, EN2, EN3, all their strands of the automotive society, they are IITs. And it's a great that EN2, where there was absolutely no money, we didn't have any funding, that we have 64 sites, even MD Anderson joined us, which is the strength that we started this question of adjuvant chemotherapy was important in endometrial cancer. No pharma would be interested in, but we did it, and we are now chasing the events. So this is, I think, the strength of NGOT, the same as Alison said, what an idea, that's what we do is, what we do is that when a group has an idea, we help them if they don't have contact to get grants, we try to help together to show to the grant providers that here, we are strong, we can do this, this is a great idea, let's get the grant and let's get it done. And that if NSGO was alone for this EN2, for example, as I like the 25 million of Australia, we are 27 or 28 million. We would never finish the trial. And this is the way we do it. So I think the industry also respect us and they respect us that we deliver. We have an idea, we do it, we deliver. And when it comes to the model, A, we can get the grants because we are together and we can deliver. Right. Each one of you has mentioned the words, surgical trials. And I think these are, again, very difficult to do because it's hard to get any kind of sponsorship for those trials actually was, kind of the traditional domain of our government or funded resources. But obviously they're important and they're part of what we do. Obviously it's part of our modalities as gynecological oncologists, we provide those opportunities. Tom, I wanna go back to you just briefly about the efforts that are being done within the partners group specifically with respect to how surgical trials can be done. You mentioned that DOG Partners was largely funded by pharma. So we've got a few trials that are working its way through. So how are we doing that? Yeah, Rob, great question. How are we being so persuasive? Yeah, so part of it's communication, getting the right people to the table, getting a physician champion that really, or two, that really believes in the concept. And as you know, we're embarking on a trial with Intuitive to look at changing a few things from a lack trial and seeing if that makes a difference in terms of the outcome with smaller tumors and some of the techniques that are used. So those are the types of things that we're able to do. And DOG Partners has been forthcoming in financial support for these trials as well. Certainly they've been getting grants from industry to support these as well. They're not doing it all on their own, but there is some underwriting of these trials as well in terms of data management and so forth that we've been providing. So it's very helpful. Yeah, one thing I'll bring up with this just because being part of this exercise as well is that the idea came in and then the next thought was, okay, how do we look at the important aspects of that trial and see if there'll be interested parties who'd want to at least carve out a component of it? So we knew, obviously, in kind of a new adjuvant setting, we would have access to potentially the tissue pre and post exposure. So again, I think Allison and Marie both brought this up is that there's this opportunity to brainstorm and bring and develop new ideas to bring these kinds of ideas forward. So we're gonna get this trial done. That's the high-tech concept there in OVRI, which many people try it. I know Dennis Chee's been trying to get this done for a long time, and it's a wonderful question to be asked in any way. And it's been answered in a very controlled manner with large patient numbers to see if this more arduous and potentially toxic treatment really makes the difference that we've seen in at least one of the even phase three publications. So we need to really study this carefully because this could be a game changer for some of our patients. And I think that it's exactly right. What you said is, again, getting the right stakeholders, but thinking creatively. As you said, there's translational components that some of the diagnostics companies could be very interested in, in terms of validating tests and so forth. So real opportunity. Awesome. Yeah, Alison, please. So Robert, I think one of the things with all trials, but particularly with surgical trials is you really have to have a champion. You have to have somebody who's absolutely willing to spend days and nights and months and months and years to get this off the ground, as Marie knows all too well. And I had a little bit of experience with trying to get static off the ground, which did not succeed. But there has to be interest. And I think it speaks with no disrespect to Mansoor about how we might move surgical trials forward is that there are a number of gynecologists on this panel. And in fact, I think for the first time we outnumber medical oncologists when we're talking about clinical trials. So I can only see the future getting brighter and brighter and brighter. Oh, yeah, exactly. Yeah, yeah, yeah. That was purposeful, yeah. Well, I think, Alison, you made a great point. I can give you, I mean, desktop story. The TRUST trial, we thought that, Marie, you did, I mean, who could even imagine that you could put up this cervical cancer trial and get it, all of a sudden, there were a thousand patients recruited. This is, you know, I take a hat off for the surgeons who really, you know, enthusiastically finished these trials. One of the very, very special difficulty of surgical trials is quality assurance. It's not like a chemotherapy trial where you just adjust the dose according to the blood tests. And, you know, it's pretty systematic and relatively simple. Relatively. Yeah, no disrespect for you, sir. The radicality, for instance, of the surgery and so on, is quite difficult to standardize. It's feasible and it's doable. And I think that we've shown it with cervical cancer trials recently, yeah. Rob, if I could just follow up on Alison's point. I think it's really well taken. And that goes with, you know, how important mentorship is. And that's been a real opportunity. You took the words out of my mouth. That's exactly what I was going to go to next. I'll let you do your thing. Thank you. Go ahead. Yeah, no, no, no, you go ahead. Go ahead. No, I was just going to say that, you know, that's something that we've really embraced in the GOG partners in terms of setting up our young investigators. We have scholars program, all of which have been big investments. Ronnie Alvarez and Angeles Alvarez-Sakura both asked for a lot and received a lot, but they went big. Our president, Dr. Copeland said, go for it. And we have, we've spent tremendous resources on these programs. We've started the investigators council as well, which is a way of engaging our high quality investigators who have a commitment to accrual, but we want to grow them even more in terms of being able to conduct trials, design trials, and move up in the leadership. It's so important that organizations do that. And we've been doing that with involving them in committees, meetings, ad boards, all these things, papers, steering committees. It's just vital. It's our lifeblood for the future. Yeah, I couldn't agree with you more, Tom. I, you know, the mentorship is such a, is so important. I, it's got, and the thing is it takes, just like everything else, it takes active thinking about it. It's very easy to get into a comfort zone of, you know, of running a trial and then being asked to run a trial. Again, you have to actually step out and say, hey, wait a minute. We got some other people we want to bring in. And if they're really new, we bring them in as observers. And then, you know, they migrate through the ranks. You know, each of the, each of you guys, your organizations have some form of meeting that you get together and discuss, you know, these concepts. And I'm curious, let me go back to Allison. With the, with respect to the GCIG, you know, what is your way to help foster this spirit of mentorship? I know you have a lot of committees, but how do you, I know you have to take a proactive approach. I'm just curious as to how you guys leverage that at GCIG. Well, I think, I think in, you know, I think we've developed this over the last five years or so. I think prior to that, we were kind of just busy getting ourselves established with all the national groups, but we've really realized, I think as many groups do once they've grown and developed, that the secret to ongoing success is bringing up the young guns really, and the people with the energy and the ideas. So one of the things that we brought in fairly recently was that of the six people that each group could bring to a meeting, one of them had to be a young investigator, just to give them a flavor of what was going on. And for them to meet other investigators from other groups. I remember the first time I went to my GCIG meeting, I was just blown away by all these people who had just read their papers. I'd never, never actually thought that I would, I would be sitting down next to them, having coffee or at dinner or whatever. And it just, you know, it's such a fantastic way to get involved in the whole process. We also have an educational committee and we have educational sessions and really trying to bring in ways of teaching young investigators in countries where there might not be a lot of infrastructure to how to conduct a clinical trial. So we have, during COVID, we've had virtual meetings to do that. And so I think, you know, no group can survive if they just do things the same way that they've always done. They have to continually move forward and really bring in new blood on a regular basis. And that's what we've been trying to do as well. Yeah. And Marie, with respect to CCRN, how are you bringing in, you know, these new investigators, I think, into your study group, actually, to get trials conducted? Yeah, we had the opportunity to piggyback to GCIG, particularly what's called a Young Investigator Program that Alison was just talking about, which has been developed, I believe, by Andres Bovedo initially. And that's a whole day of presentations and didactics and sessions about how to set a clinical trial, how to develop the endpoints. I mean, it's very, very thorough and extensive. And again, I mean, virtual meetings have advantages. And one of them being that LMIC groups that belong to CCRN can attend at no cost and benefit and participate to these sessions and educational sessions. And we've made that available to IGCS as well, mentorship programs. So I think this is all good. And this is how you bring up the young generation, the young gen, as we call it. And that's just the way to go. So important. And then, sir, let me, with respect to NGOT, you know, this, again, it's hard because it's a group of groups, but, and I imagine each of the groups have their own kind of mentorship program, but you run one of these groups, the, or you've been the chair of one, the NSGO. What are the, what kind of programs do you have been leveraged, you know, within the NGOT groups? For the last many years, we have been running so-called GCA, the Gynecologic Cancer Academy, and the idea is to develop the next generation of leaders. And we already have achieved the beginning. I can give you an example. Philip Harter was taught in GCA. Now he's leading the Argo German group. Keita was also one. And Ingrid Borough, all these are now leaders, and they were the ones who attended that academy and became the leaders. So what we are doing is we are educating, and I think it is extremely important. We are educating the next leaders in this very structural way. That's one thing. Second thing is we have a program to help the coordinators, the office personnel to teach, because all the time you have new people coming in, new groups have to, so we have developed a program of masterclass for the, for so-called, as you said, harmonization group, and it is working very well, and we have actually that on demand. And we can actually discuss if you would like to have that on demand from us. It's on the ESCO webpage. So I think we have tried to put all these things together. The next step we are doing is we are doing masterclass. So one thing is to develop the next generation leaders. The second thing is bringing the whole young people up to understand why we need to do clinical trials, what is interesting in that. So we are together with Enigo, which is the ESCO Young Oncologist Group. We are doing masterclass with ENGARD, teaching them or giving them the idea. Let's, guys, there is something called more than just going in and giving, what did you say, Marie? Giving chemotherapy this way or the other. Or doing a small surgery or standing beside the surgery. There is something called clinical trials, and we are trying to develop that in the masterclass. Well, thank you so much. Well, listen, we're at time, and I just want to say, I've been watching the chat. So people from all over the world, it's so great to see people basically calling and saying thanks for the efforts that you guys are reaching all parts of the globe. And of course, IGCS, that's what the I is in IGCS International. And so I'm so pleased and thankful to each of you, respecting your own organizations with a focus on clinical trials, which as I mentioned, really is the process, the mechanism, the engine that drives the new standards of care. And I can't thank you enough for your commitment, each of you being leaders in our field who have driven that change all for the betterment, as Tom mentioned, our most precious resource, which is our patient. So thank you all, all of you for joining me today and many congratulations on your efforts. And here's the hope for the future. I know we're in great shape. Thanks again. And thanks, everybody. Thank you. Thanks, Rob. Thank you. Thanks, Rob. Bye now. Bye.
Video Summary
The video is a panel discussion among representatives from different organizations involved in gynecologic cancer research, including the Clinical Cervical Cancer Research Network (CCRN), Gynecologic Cancer Intergroup (GCIG), European Network of Gynecologic Oncology Trialist Groups (ENGOT), and Gynecologic Oncology Group Foundation (GOG Foundation). The discussion focuses on the importance of international collaboration in conducting impactful research, particularly in the field of surgical trials. The speakers highlight the challenges faced in funding such trials, especially for investigator-initiated trials that are not supported by pharmaceutical companies. They also discuss the role of mentorship in developing the next generation of researchers and leaders in the field. The panelists emphasize the need to facilitate access to clinical trials for low- and middle-income countries and the potential benefits of collaboration with pharmaceutical companies to support academic trials. The organizations also share their initiatives and programs aimed at addressing disparities in education, mentorship, and care in gynecologic cancer globally. The panel concludes with reflections on the importance of international collaboration and the potential for future advancements in research and patient care.
Keywords
gynecologic cancer research
international collaboration
surgical trials
funding challenges
mentorship
investigator-initiated trials
low- and middle-income countries
academic trials
disparities in education
advancements in research
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