Virtual clinical trials would have a tremendous advantage in expanding the reach of clinical trials

Suneela Thatte, VP and Head - R&D Solutions India, IQVIA speaks on the challenges faced by CROs due to the pandemic, the subsequent learnings in clinical research/trials, emerging trends in this arena and more, in an interaction with Viveka Roychowdhury

- Viveka Roychowdhury

How did CROs like IQVIA cope with lockdown restrictions, to ensure minimum disruption of clinical trials as well as patient and staff safety?

Given that the lockdown was announced suddenly and unexpectedly, there were initial challenges with ongoing studies due to the restrictions in place. It was the perseverance and commitment of our clinical team that ensured patient safety, delivery of supplies, protocol compliance and overall study continuity. Despite all the challenges, the team worked relentlessly in collaboration with other stakeholders and were able to ensure studies were not impacted and, most importantly, that the health, safety and well-being of patients were safeguarded.

Right from the early stages of the pandemic, we had guidance in place to protect our employees and ensure that their own safety was in no way compromised. The guidance was more stringent for our site-facing staff. As in-country restrictions were tightened, and subsequently eased, the guidance was revised, ensuring continued focus on employee safety.

At a global enterprise level, IQVIA’s Research & Development Solutions COVID-19 task force quickly mobilised to develop a standardised approach to risk assessment for both in-flight and new clinical trials.

What are the changes in clinical research/trial execution that were good learnings that will stay in place post lockdowns? (like increased remote patient monitoring, adaptive trials, etc)