Monitoring clinical trials during a pandemic – the India experience

During the COVID-19 pandemic, clinical trials have been faced with the understandable challenge of limited resources. This is compounded by research staff and healthcare workers who contract COVID-19, resulting in illness and absence which often leads to disruption in study conduct.

At the height of the COVID pandemic in India, recruitment into the ASCOT-ADAPT trial exponentially increased and hospitals were inundated with a high patient load and minimal resources to dedicate to trial data. As a result, data entry into the database was delayed. The clinical monitoring team in TGI India under the leadership of Dr Oommen John has worked tirelessly with the hospitals to ensure data completeness for the interim analysis of the first 300 patients. Data is now 95% complete for the interim analysis to be conducted by the Data, Safety and Management Board which is meeting on 21 July 2021. The TGI clinical monitoring team was asked about the strategies they used to reach this target.

Dr oommen JohnDr Rajesh JoshiPurnima Rao JevajiPrashanthi Kamath

Purnima Rao Jevaji said, ‘a great effort was required to support the hospital staff until their workload stabilised, which included being available to them during out-of-office hours and sending regular reminders via email, phone and WhatsApp’. The support of the site’s Principal Investigator was also crucial. Doherty Institute’s Associate Professor Steven Tong, lead investigator of the ASCOT-ADAPT trial commended the team, acknowledging the hard work that was required to get to this point.