Also the new EU Clinical Trials Regulation No. 536/2014 clearly shows a trend away from a “one size fits all” strategy for the planning and performing of a clinical trial: by introducing the “low intervention trial” category, the regulation diverges from a standardized procedure for all clinical trials.
This new approach takes into account that the risk profile and practical requirements of a first-in-man study significantly differ from those of a phase IV trial with an authorized drug.
Similarly, the regulation describes that the extent and type of actions regarding e.g. adverse event reporting (article 41), handling of investigational drugs (article 51), monitoring (article 48) und trial master file (article 57) should be tailored towards the particularities of the trial.
In its consultation document “Risk proportionate approaches in clinical trials” which was open for consultation until the 31st of August 2016, the EMA Expert Group gives advice on the implementation of the Clinical Trials Regulation No. 536/2014. Among other things, the paper gives examples on how a risk-based approach can be applied for “low intervention” trials with respect to the above mentioned areas of clinical research.
Most importantly, the risk-based quality management approach will also be incorporated within the “bible of clinical research”, i.e. in an addendum to the ICH Guideline for Good Clinical Practice (ICH-GCP). The draft version of the revised ICH-GCP Guideline has already completed the public consultation process. However, according to this years’ EUCROF Conference on Clinical Research, the final version of the guideline which was originally planned for November 2016 may take as long as mid-2017.
The addendum takes the subject risk management to the next level, and keep in mind that both, by the “old” (current) legislation (AMG §40(1)) and by the new Clinical Trials Regulation (article 47) the principles of Good Clinical Practices of ICH are legally binding. Thus, the implementation of a risk-based quality management for a clinical trial no longer remains within the judgement of the sponsor but actually becomes a legal obligation.
Even more: the final clinical study report in future has to include a description of the performed risk assessment and quality management approach as well as a description of important deviations from the predefined quality standards. And, last but not least, auditors and inspectors – who base their valuation mainly on ICH-GCP guidelines – will also take this aspect into account for their judgement.