Advisor 465

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

ICMRA stresses the value of safe and effective COVID-19 vaccines Efforts are being made by the International Coalition of Medicines Regulatory Authorities (ICMRA) to improve the public understanding of and confidence in vaccines. ICMRA held its fifth virtual meeting of regulators

of COVID-19 clinical trials that might produce conclusive evidence on the efects of potential treatments and vaccines against COVID-19 – provided that the safety of trial participants is ensured – was stressed. Members reiterated that the research community should pool resources into large, well-designed, randomised clinical trials to determine which investigational or repurposed medicines would be safe and efective for the treatment or prevention of COVID-19. Master protocols Participants discussed the use of COVID-19 clinical trial master protocols around the world to accelerate the development and approval of potential treatments and vaccines. ICMRA members are currently working on a list of ongoing and planned COVID-19 clinical trials with master protocols in diferent countries and regions, in order to compare the protocols and identify possible overlaps (eg. objectives and types of investigational agents studied). Regulators aim to update this list on a regular basis. ICMRA Working Group The ICMRA Working Group on COVID-19 provided meeting participants with an update on its activities related to clinical trials, potential

from around the world on 12 June 2020 and discussed high-level policy issues and regulatory approaches to ensuring a coordinated response to the ongoing COVID-19 pandemic. ICMRA is a voluntary grouping of 29 medicines regulatory authorities from around the world, set up to provide strategic coordination, advocacy and leadership. It acts as a forum to support international cooperation among medicines regulatory authorities. On 28 April 2020, ICMRA members committed to strengthening global collaborative eforts in order to facilitate the rapid development, approval and global roll-out of safe and efective medicines to prevent and treat COVID-19. In this role, ICMRA is holding bi-weekly meetings to allow medicines regulatory authorities worldwide to discuss COVID- 19-related policy approaches and regulatory flexibility, aiming not only to expedite COVID-19 medicines and vaccines development and approval but also to prevent medicines shortages. Their virtual bi-weekly meetings commenced in April 2020 and the most recent took place on 12 June 2020. Clinical trials Meeting participants discussed the progress made on the development of ICMRA guiding principles for COVID-19 clinical trials and the prioritisation of compounds. They agreed that a clear distinction between exploratory clinical trials and confirmatory studies with investigational or repurposed medicines for the treatment of COVID-19 is critical for clinical trial prioritisation. Regulators shared concerns about the discontinuation of clinical trials globally and the growing number of underpowered studies that might not generate the robust data required for regulatory decision making. The need for the continuation

therapeutics and vaccines. Topics under discussion include ethical questions around human challenge trials and post-approval requirements for COVID-19 vaccines.

Improving vaccine confidence On 17 June, ICMRA issued two statements about the importance, safety and efectiveness of vaccines. International regulators from around the world have come together and jointly developed these page 7 u

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Issue 465, 2020 www.brookwood-global.com