Article Text
Abstract
Introduction Developing an EDI strategy for academic clinical trials in India is a challenging prospect with 1.4 billion population (1/5th of world), 28 states, 780 official languages, ~20,000 dialects and 2000 ethnic groups. We describe our novel KOLGOTRG systematic EDI strategy for sampling and site selection for the IPIROC Phase 2 PARP inhibitor de-escalation RCT in recurrent ovarian cancer funded by the Indian Council of Medical Research.
Methods An EDI hallmark organogram was created representing major determinants of diversity in India which include geographic, socio-cultural, genomic and economic diversity (figure 1). A site selection criterion and provider survey were developed to represent each state, health care system (government versus private), logistical convenience for recruitment and provider advocacy (figure 2a).
Results 200 potential trial recruitment sites were shortlisted across India based on the EDI framework and geo-spatial mapping; A phase-wise systematic RCT approach (Rationalising and reducing the cost of running randomised controlled trials in low-resource settings) was applied to maximise physician involvement and minimise cost burden for recruitment per site but preserving the diversity and capacity building mandate for the next-in-plan Phase 3 trial in frontline setting. Finally, 50 sites were designated as potential ROCK (regional ovarian cancer centre KOLGOTRG) trial recruitment sites for the Phase 2 trial for an estimated screening of 500 women and recruitment of 164 women (1:3 control versus intervention arm) (figure 2b).
Conclusion/Implications Meticulous and systematic planning is essential to implement EDI principles in academic clinical trial recruitment in India.