At the International Coalition of Medicines Regulatory Authorities (ICMRA) regular virtual meeting, high-level policy issues and regulatory approaches to ensure a co-ordinated response to the ongoing pandemic were discussed.
Meeting participants normally include regulators from around the world, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who are taking turns to chair these meetings.
Regulators discussed the progress made on the development of ICMRA guiding principles for COVID-19 clinical trials and prioritisation of compounds. Concerns were shared about the discontinuation of clinical trials globally and the increasing number of “underpowered” studies that might not provide enough robust data for regulatory decision-making. All participants re-emphasised the crucial need for continuation of COVID-19 clinical trials that have the possibility of producing conclusive evidence on the beneficial effects of potential treatments and vaccines, as long as the safety of trial participants is ensured. It was recommended that the research community pool resources into large, well-designed, randomised clinical trials to determine which investigational or re-purposed medicines would be safe and effective.
The use of COVID-19 clinical trial master protocols was also a key topic for discussion. Harmonised protocols could help to accelerate the development and approval of potential treatments and vaccines against COVID-19. Regulators are preparing a comparison list of current and planned COVID-19 clinical trials with master protocols in different countries and regions, which would aid identification of possible overlaps, for example regarding objectives and types of investigational agents studied.
This ICMRA meeting also provided updates on other topics such as ethical questions around human challenge trials and post-approval requirements for COVID-19 vaccines.
The ICMRA COVID-19 Working Group will keep updating all members on the progress of these initiatives. For more information, click here.