ETHICS AND COMPLIANCE IN CLINICAL TRIALS: NEXT GENERATION
It has been more than two years since the coronavirus (COVID-19) pandemic changed our lives. Apart from colossal changes to our own personal health, the ways we purchase goods, how we educate our children, how we run multi-participant events and even the vocabulary we use (keeping ‘social distance’, ‘flattening the curve’ and drinking ‘quarantini’ cocktails), COVID-19 appears to have catalysed quantum leap changes in global sectors.
In healthcare, we witnessed how medical teams in hospitals, scientists, researchers, small biotech firms and big pharma players made heroic efforts (jointly and separately) to fight the pandemic. The entire ecosystem has been unleashing science and technology disciplines and using data and analytics to understand the rise of new variants and patterns of their spread, to develop new technologies for rapid diagnosis, and to conduct fast but still rigorous clinical trials focused on prevention and treatment.
The world was waiting for urgent prevention and therapeutic approaches to counter this disease. Consequently, there was considerable pressure to develop solutions as fast as possible. However, the ‘traditional’ clinical trial model is not suited to COVID-19 restrictions such as lockdowns or travel restrictions. Therefore, design and execution of clinical trials needed to transform, moving toward decentralised and hybrid trial models, characterised by virtual elements, advanced technologies (even blockchain), apps and home visits and, as a practical matter, moving away from traditional face to face interactions. Have we transformed the way we run trials in general?
Apr-Jun 2022 Issue
Novartis Research & Development