Risk-Adapted Approach to Clinical Trials and Risk Assessments

On 28 January 2022 the MHRA issued guidance on how to implement a dual strategy for a risk-adapted approach to clinical trials in the UK.

The first part of the strategy is the stratification of trials into type A, B or C dependent upon the use of the investigational medicinal product (IMP) in relation to its marketing authorization or an unlicensed IMP, i.e. the risks associated with the IMP. This would impact on the MHRA authorization process, indicate potential changes to trial documentation requirements and inform the safety monitoring plan.

The second part is a bespoke approach. This is a trial-specific risk assessment to identify specific vulnerabilities in the trial conduct that could impact on the trial results and the protection of trial participants safety, rights and wellbeing. This risk assessment would document the mitigations for specific identified risks and any adaptations from traditional GCP. These would then be developed such that there would be risk proportionate management and monitoring of the trial.

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