Risk-Adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products

The concept of risk-adapted approaches to clinical trials was implemented by the MHRA for UK trials on the 1 April 2011. This approach was the outcome of a risk-stratification project initiated by an ad-hoc working group under the auspices of the Department of Health, the MHRA and Medical Research Council and intended to simplify the processes for initiating and conducting clinical trials with investigational medicinal products.

The risk-adapted approach relies on a risk-stratification in relation to how much is known about the medicine(s) being investigated. Categorising the risk associated with the IMP allows for several risk adaptations within the scope of the Clinical Trials Directive. For lower-risk trials, this simplifies the requirements for both obtaining regulatory approvals and conducting the trial.

Researchers working non-commercial sponsored trials may in the first instance use this guidance to assess the spectrum of potential risk associated with IMPs and the range of regulatory requirements that may be adapted. Specifically for IMPs, the following requirements are impacted:

  • IMP Dossier
  • Good Manufacturing Practice (GMP) compliance
  • Labelling of trial drugs
  • IMP management (tracking, accountability and storage)

The applicability of the reduced requirements needs to be carefully established from the guidance. As the risk adaptations are not applicable in all cases of trials involving IMPs, researchers should be aware of the other considerations discussed in this station.

The MRC/DH/MHRA Joint Project document can be accessed online:
https://www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf