Title:COVID-19 and Clinical Trials: Current Challenges and Future Directions
Volume: 16
Issue: 3
Author(s): Vinay Singh*, Sandeep Garg, Monika Klimek, Rajeev Ranjan Sinha and Dinesh Dhanwal
Affiliation:
- Department of Medicine, Maulana Azad Medical College, New Delhi,India
Keywords:
Clinical trials, challenges, coronavirus, COVID-19, strategies, digitalization.
Abstract:
Background: The outbreak of coronavirus disease (COVID-19) has posed a major
threat to people's lives across the globe. It has drastically changed the way we perceive this world.
A paradigm shift was observed globally as the world’s emphasis shifted to testing, diagnosis, treatment,
and developing a coronavirus cure. Clinical trials were also not untouched by this. The coronavirus
pandemic has abhorrently affected the day-to-day clinical trial activities at sites.
Methods: The status of various ongoing clinical trials was assessed through a literature search,
which also includes clinical trial portals. Our evaluations were based on these observations.
Results: Multiple challenges were present in clinical trials as recruitment, retention, the safety of
trial subjects, protocol compliance, and this made the world to re-think to incorporate newer strategies
and to cope with this untoward situation.
Conclusion: Digitalization of clinical trials as virtual management of adverse events, remote monitoring
visits, and web-based consulting with trial subjects are potential directions that can be applied
to better manage clinical trials worldwide.