The World Health Organization (WHO) declared the spread of COVID-19 to be a Public Health Emergency of International Concern (PHEIC) on January 30, 2020 and then characterized it as a pandemic on March 11, 2020. Till September 1, 2020, there are about 25 million cases and about 1 million deaths worldwide due to COVID-19. With these numbers poised to grow, we observe that with an overstretched healthcare infrastructure there are humanitarian challenges of unprecedented levels.

Globally Clinical Research has been in the forefront, for understanding the nature of the virus and trying diagnostics, therapeutics or preventive measures including vaccines, seeking insights on how to be prepared to face next infectious disease pandemic. In addition to clinical trials, epidemiological and socio-behavioral studies play a critical role in reducing morbidity and mortality and improving preparedness for future pandemics.

Clinical Research of new therapies and vaccines raise special challenges in such Public Health Emergencies. Researchers, sponsors and funders have general obligations to make sure that studies are scientifically valid, have social value, involve equitable distribution of risks and benefits, and involve fair selection of participants There may, however, be a conflict between requiring valid scientific design and providing access to possibly beneficial interventions. Resolving this conflict involves attention to the choice of an appropriate control group, providing access to interventions to those who cannot participate in trials, and fast-tracking approvals for emergency use.

Arriving at an appropriate balance between scientific validity and timely access to effective interventions involves weighting and prioritizing of potentially competing ethical values, but also issues of appropriate regulatory standards. In this webinar, speakers will discuss these issues, both from an ethical and regulatory point of view. The speakers will provide a background from both the international as well as Indian context.