International regulators align positions on phase 3 Covid-19 vaccine trials

Considerations for study design for phase 3 clinical trials

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Medicines regulatory authorities from around the world have published a report highlighting the outcomes of the second workshop on Covid-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

The report describes the regulatory positions agreed by the meeting participants on two key topics, including data needed from the laboratory, animal and human studies to allow initiation of phase 3 clinical trials for a Covid-19 vaccine and considerations for study design for phase 3 clinical trials.

Phase 3 is the last phase of testing a vaccine before it can be submitted to a regulatory authority for evaluation and possible approval. The main focus of phase 3 trials is to demonstrate the efficacy and safety of the vaccine.

The meeting participants stressed the need for large phase 3 clinical trials that enroll many thousands of people, including those with underlying medical conditions, to generate relevant data for the key target populations.

There was also broad agreement that clinical studies should be designed with stringent success criteria that would allow a convincing demonstration of the efficacy of Covid-19 vaccines. However, whether a vaccine would be considered acceptable for approval is assessed case-by-case based on all available data on its safety and efficacy.

The workshop was held to encourage regulatory convergence, to the extent possible, on certain key aspects of phase 3 clinical trial designs to help developers generate robust evidence on the quality, safety and efficacy of potential Covid-19 vaccines that meets the needs of regulators around the globe. This is critical for expediting and streamlining global development and the authorization of vaccines against Covid-19.

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