In response to a request from the Department of Health in 2009 to
identify and suggest remedial actions to major obstacles to
non-commercial clinical trials research in the UK, the MRC and MHRA
formed a group to address risk-proportionality in trial management
and monitoring. Their remit was to:
- Develop a process to facilitate the agreement of key
stakeholders on the level of risk associated with a clinical trial
of an investigational medicinal product (CTIMP)
- Identify how risk-adapted approaches for CTIMPs can be achieved
within the current regulatory framework
- Develop guidance on risk assessment and the risk-proportionate
management of clinical trials.
The resulting guidance focuses on the risks inherent in a trial
protocol which impact on participant safety and rights, and the
reliability of the results.
A two-part assessment is suggested. First, a simple IMP
risk categorisation based on marketing status and standard medical
care, and second, an assessment of the trial design, population and
procedures to identify specific areas of vulnerability.
Both the risk category and safety monitoring plan resulting from
the vulnerability assessment can be submitted to the MHRA with the
Clinical Trial Authorisation application to ensure there is shared
understanding on this key aspect of a trial.
The guidance is available here: