Pragmatic Clinical Trial Resources-Slides - Pragmatic Clinical Trials in Resource adapted settings: Implementation and novel designs

Pdf Summary

The document presents a detailed overview of pragmatic clinical trials in resource-adapted settings, with a focus on gynecologic oncology. It emphasizes that pragmatic trials should be patient-centered, practical, adaptive, ethical, cost-conscious, and implementable in real-world health systems, especially in low- and middle-resource environments.<br /><br />A major theme is collaboration through international networks such as GCIG and CCRN, which support multicenter studies, consensus guidelines, educational symposia, and broader geographic representation, including participation from India. The talk highlights the importance of involving young investigators, early-career clinicians, and patient/provider advocacy in building sustainable research capacity.<br /><br />The document outlines several novel trial designs suitable for resource-limited settings, including master protocols, umbrella and platform studies, SMART designs, registry-based randomized trials, trial-within-cohort designs, adaptive randomization, synthetic controls, and prospective meta-analysis. It argues that these approaches can reduce cost, improve efficiency, and allow triangulation of evidence using interventional and non-interventional data.<br /><br />Examples are given from ovarian and cervical cancer. For ovarian cancer, the presentation proposes a biomarker-driven umbrella strategy for PARP inhibitor maintenance, including intermittent versus daily rucaparib, with patient-choice and observational pathways. For cervical cancer, the DEBRACA master protocol explores de-escalation of brachytherapy and surgery-tailored approaches in resource-stratified settings.<br /><br />The document also stresses implementation issues: site selection, infrastructure, ethics, recruitment, follow-up, data collection, telemedicine, and minimal datasets. It proposes the EASE framework—ethical, adaptable, affordable, scalable, effective, and encouraging innovation—as a guide for successful pragmatic trial implementation.<br /><br />Overall, the message is that well-designed pragmatic trials can generate locally relevant evidence, improve equity and access, and help shape policy and care delivery in settings with limited resources.

Asset Subtitle

Slides provided by Prof. Asima Mukhopadhyay

Keywords

pragmatic clinical trials

resource-adapted settings

gynecologic oncology

low- and middle-resource environments

international research networks

master protocols

adaptive trial designs

ovarian cancer

cervical cancer

EASE framework