Global Teams Collaborate to Innovate Ovarian Cancer Trials in India

A dynamic collaboration between the University of Michigan faculty and public health researchers in India is reshaping how clinical trials are conducted in low-resource settings, aiming to optimize ovarian cancer treatment strategies while building a new model for smarter, patient-centered, and cost-effective research.

The Rationalizing and Reducing the Cost of Running Randomized Controlled Trials in Low-Resource Settings (R2CT) project was launched to address the significant disparity in cancer treatment regimens between high-income countries and low- and middle-income countries (LMICs). Asima Mukhopadhyay, MBBS, PhD, founder and director of the Kolkata Gynecological Oncology Trials and Translational Research Group in Kolkata, India, developed R2CT to meet the urgent need for novel, pragmatic clinical trial designs adapted to the unique challenges of LMICs and other resource-restricted settings. Many cancer therapies, such as PARP inhibitors, are based on studies conducted in high-income countries — often with very low representation from LMICs — raising concerns about feasibility, safety, and effectiveness in these different settings.

This first case study centers on ovarian cancer in India, where current dosing strategies from high-income countries are often not suitable due to distinct patient demographics, comorbidities, and treatment access. The research also highlights broader challenges, such as affordability and variations in prescribing practices, that are critical for designing low-cost, high-impact interventions. Ultimately, the project aims to create a methodology that can be applied across a variety of diseases and conditions in low-resource settings.

Supported by a Seed Grant from the Center for Global Health Equity at the University of Michigan, this initiative brings together a diverse team of global experts. Collaborators include Kelley Kidwell, Brad Zebrack, and Shitanshu Uppal from the University of Michigan; Bhramar Mukherjee from Yale University; Sofia Villar from the UK; and researchers Asima Mukhopadhyay, Daity Bhattacharjee, Atanu Bhattacharjee, and Salamatu Abdul-Aziz from the Kolkata Gynecological Oncology Trials and Translational Research Group—an Indian Council of Medical Research Collaborating Center of Excellence.

One key activity of the project was a prospective survey of physicians across several clinical centers in India. This survey explored prescribing practices for the targeted anti-cancer drug PARP inhibitor, focusing on usage patterns, dose preferences, treatment-related side effects, and preferred medications considered standard of care in clinical trials. Findings from the survey, along with in-depth interviews with clinicians, are being used to identify treatment regimens that are better aligned with the needs and realities of patients in low-resource environments. This effort complements a systematic review examining how women from LMICs are represented in PARP inhibitor trials that determine dosing and treatment duration, which often results in prescription patterns unsuitable for women outside developed countries.

To build local research capacity, the Kolkata Gynecological Oncology Trials and Translational Research Group hosted a series of hybrid workshops on study design and clinical trial analysis. These sessions were developed in partnership with faculty at the University of Michigan, who contributed virtually to curriculum design and instruction. The workshops provided essential training for local statisticians and health researchers, ensuring they are equipped to lead future research that responds directly to community health challenges.

The R2CT team has completed pilot data collection and is now analyzing results, planning to expand the study within India and internationally in 2025. The next milestone is a white paper, expected in 2026, which will offer a practical blueprint for designing clinical trials in resource-limited settings. The goal is to promote trials that are easier to conduct and adhere to, more affordable, and ultimately more likely to produce meaningful, generalizable results that improve outcomes for patients in LMICs. By drawing on real-world practices, R2CT is helping to create clinical trials that are smarter, more patient-centric, and contextually relevant, providing a model that could be applied across diseases and settings worldwide.

This initiative vividly demonstrates how global health equity can be advanced through coordinated efforts and interdisciplinary innovation, directly fulfilling the center's mission to create a lasting impact on global health challenges. It not only addresses ovarian cancer but also lays the groundwork for broader applications across various diseases and LMICs, significantly promoting health equity and the development of tailored treatment protocols.