The European Medicines Agency (EMA), in cooperation with the European Commission and member states of the European Union (EU), is proposing changes to the current guidance on first-in-human clinical trials. This is aimed at improving strategies to identify and mitigate risks to trial participants. These changes have been released for public consultation.

Clinical trials are essential for the development of medicines and without them patients cannot gain access to new potentially life-saving medicines. At present, EU and international guidelines are in place to ensure that first-in-human clinical trials are conducted as safely as possible. These guidelines include the requirement for extensive studies to gather information about a medicine before it is given to humans.

The release of the concept paper is part of a review of the EMA guidelines published in 2007 that provide 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 parts of the current guideline that need to be amended to take into account the evolution of practices in conducting clinical studies since the guideline was first published. The review also takes into account the lessons learnt from the tragic incident which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016.

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 (eg 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.

Source: EMA

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