International regulators provide guiding principles for COVID-19 clinical trials
“As the COVID-19 pandemic continues to evolve in many countries, we have seen unprecedented global collaboration and a surge in research and development of potential medicines and vaccines against coronavirus disease around the world,” said Guido Rasi, Chair of ICMRA and EMA’s Executive Director. “We, as regulators, support the trials that are providing robust and reliable results required for regulatory decision-making, and evidence that can be used across the globe for all patients affected by COVID-19.”
In their joint statement, international medicines regulators describe the key characteristics of clinical trials that are most likely to generate the conclusive evidence needed to enable the accelerated approval of potential treatments and vaccines against COVID-19. They also set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to collect, analyse and report the data required to determine which investigational or repurposed medicinal products would be safe and effective for the treatment or prevention of COVID-19. Medicines regulators also encourage investigators to make the results fully and quickly accessible, both to participants in the clinical trials and the public so that the global research community can benefit from that information.
Global regulators emphasise their commitment to cooperate, expedite and share the evaluation of all COVID-19 trial results submitted to them. They also pledge to provide clear and transparent benefit-risk analyses in order to support the approval of effective and safe medicines, biologics and vaccines against COVID-19.
The development of a joint statement on clinical trials followed a series of meetings and discussions among ICMRA members on priority criteria for planned trials to enable rapid assessment and authorisation of COVID-19 therapeutics and vaccines. Progress will be monitored, discussed with all ICMRA members and reported in the coming months.