Emerging risks in COVID-19 clinical trials

As the scientific community races to respond to COVID-19, best practice is slipping in clinical trials. What trade-offs are being made and who is liable?

The urgency of the COVID-19 health crisis has led to a frenzy of clinical trial activity. After the Chinese authorities shared the COVID-19 genome with the international community in January 2020, it took just six weeks for the first candidate vaccine to be shipped for human clinical trials. By early August 2020, close to 3,000 trials were under way around the world, attempting to halt the progress of COVID-19 at different points along the biochemical pathway it takes into the human body. The pace at which these candidates were prepared shows how far both our understanding of the disease has come and the speed with which science can move.

However, with all eyes on the goal of beating COVID-19 fast and the scientific and medical communities throwing everything they have at COVID-19, there are risk implications not only for the researchers running trials, but also for product owners whose drugs are being tested against the disease. While the regulatory environment is allowing for fast-tracked trials and greater leniency, this will not extend to compromised patient safety.

The context may be a very immediate health crisis, but the trade-offs being made are creating long-term risks that someone will be liable for and which must be managed accordingly.

Read the “Emerging Risks in COVID-19 Clinical Trials” report to learn more about the emerging risks and how they can be mitigated.

Key takeaways

• It would be unwise for researchers to give drugs to research subjects who could otherwise be excluded.
• Changes and revisions to primary endpoints should be uncommon.
• Product manufacturers should stay alert to how their products are being used.
• Regulations may have been relaxed but product liability law remains the same.
• Lessons are being learnt about how to structure trials more efficiently and global coordination.