The European Medicines Agency (EMA), in cooperation with the European Commission and the member states of the European Union (EU), is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. These changes are outlined in a new concept paper that has been released for public consultation with comments being accepted until September 30, 2016.
The release of the concept paper is part of a review of the EMA guideline published in 2007 that provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants. This review identified those parts of the current guideline that need to be amended to take into account the evolution of practices in the conduct of these studies since the guideline was first published. The review also takes into account the lessons learnt from the incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016.
The EMA said that in recent years, the practice for conducting first-in-human clinical trials has evolved towards a more integrated approach, with sponsors conducting several steps of clinical development within a single clinical trial protocol (e.g. to assess single and multiple ascending doses, food interactions, or different age groups). This responds to the need for a structured approach to the conduct of these trials, with incremental decisions on next steps based on the data collected at each previous step. This enables an approach designed for the specificities of each medicine, its mechanism of action, and intended therapeutic use.
The concept paper, setting out the proposed changes to the guideline, was prepared by an EU-wide expert group that includes experts from the national competent authorities who authorize clinical trials in the EU and it was adopted by the Committee for Medicinal Products for Human Use. The EMA said that it addresses the increased complexity of the protocols of first-in-human clinical trials.
This concept paper and the comments received from stakeholders will form the basis for an update of the guideline. A draft revised guideline is expected to be published before the end of 2016 for consultation.
Source: European Medicines Agency