EMA Revises Guideline on Risk Identification and Mitigation of First-in-Human and Early Clinical Trials

• 31/07/2017
• Articles

The European Medicines Agency (“EMA”) has just revised its “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products” (the “FIH Guideline” - see attached document). The new version, which will come into effect on 1 February 2018, replaces an older version of 2007 and was prompted by the dramatic fall-out in France of a clinical trial involving nerve pain medication of the Portuguese pharmaceutical supplier Bial which was responsible for the death of a healthy trial participant and caused serious injuries to five more healthy trial volunteers. The victims were found to have received excessive doses of the investigational medicinal product.

The revised FIH Guideline focuses on the calculation of the starting dose; the subsequent dose escalations; and the criteria for determining the maximum dose. Guidance also covers criteria for stopping a study; the rolling review of data as they emerge with special reference to the safety of trial participants; and the handling of adverse events.

Additionally, the new guidance reflects the increased complexity of trial protocols which now often include different parts to assess both single and multiple ascending doses and other matters such as food interactions and different age groups.

The revised FIH Guideline formed the subject of a public consultation and a workshop. Comments on both the initial concept paper and the actual FIH Guideline will be made publicly available on the EMA website in September 2017.