International Regulators Work to Coordinate Pandemic Response

On May 14, 2020, the International Coalition of Medicines Regulatory Authorities (ICMRA) held a virtual meeting with international regulators to discuss policy issues and regulatory requirements in relation to the COVID-19 pandemic. The meeting, which was moderated by Janet Woodcock, FDA’s director of the Center for Drug Evaluation and Research, was conducted to align global regulations and approaches to clinical trial management, drug supply issues, and pharmacovigilance during the pandemic.

The use of master protocols for clinical trials around the world to accelerate development and approval of COVID-19 treatments and vaccines was discussed. The World Health Organization (WHO) detailed its Solidarity Trial and its plan to enroll patients in more than 100 countries. The Solidarity Trial will “compare multiple treatment options against standard of care in different countries,” according to EMA. “There is broad agreement among regulators that such large multi-centre, multi-arm clinical trials need to be prioritized because they are most likely to generate the robust evidence needed to enable rapid assessment and authorization of COVID-19 therapeutics and vaccines,” EMA said in a press release.

Regulatory considerations regarding exploratory clinical trials and pivotal studies with investigational or repurposed medicines for the treatment of COVID-19 were discussed. Concerns were raised about underpowered clinical trials and observational studies that compete for essential resources and patients and may not generate sufficient data. The need for regulatory requirements for COVID-19 studies was determined, and it was agreed that further guidance on the prioritization of clinical trials and on serology was needed to harmonize efforts.