European Medicines Agency Releases First-in-Human Trial Guidelines

European Medicines Agency

The European Medicines Agency (EMA) just unveiled a guidance for first-in-human clinical trials designed to help stakeholders identify and address risks for trial participants.

“Participants in these trials, often healthy volunteers, face an element of risk as the ability of researchers to predict the effects of a new medicine on people is limited before it is actually studied in humans,” EMA said in a press release accompanying the new guidance.

The revision, years in the making, is also designed to recognize the increasing complexity of clinical trial protocols over the past decade. Studies now often include different subsections within a single clinical trial protocol that are aimed as assessing such factors as single- and multiple-ascending doses, food-drug interactions, or a drug’s effect on members of different age groups, EMA noted.

Among other topics, the new guidance offers greater clarity on the criteria for stopping a study, the rolling review of emerging data with special reference to safety information for trial participants, and the handling of adverse events in relation to halting a trial or progressing to the next dosing level.

EMA will share industry comments on the initial concept paper and the revised guideline in September.

Author: Michael Causey