MHRA Updated Guidance on Managing Clinical Trials during COVID-19

On 17 February 2021 the MHRA updated the guidance by adding a section on the management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.

Sponsors for ongoing clinical trials for indications other than treatment or prophylaxis of COVID-19 are required to evaluate the impact of the current government programme for deployment of a COVID-19 vaccine on each trial they are responsible for. Separate guidance for COVID-19 vaccine trials is being agreed to with each research team.

The Sponsor should conduct a specific risk assessment for concomitant use of a COVID-19 vaccine for each IMP and with specific consideration for the trial population. Some trials may also need to consider risk assessment for non-IMPs and/or combinations.

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