EMA Guidelines on First in Human Trials Revised
The EMA guidelines on first in human clinical trials have been revised. The European Medicines Agency issued its proposed revisions to the 2007 guideline earlier this week (November 15th).
The aim of the revisions is to further enhance the safety of trial participants as trial protocols become increasingly complex. The 2007 guidelines (which came into effect on September 1st 2007) stated that its aims were:
“to assist sponsors in the transition from non-clinical to early clinical development. It identifies factors influencing risk for new investigational medicinal products and considers quality aspects, non-clinical and clinical testing strategies and designs for first-in-human clinical trials. Strategies for mitigating and managing risk are given, including the calculation of the initial dose to be used in humans, the subsequent dose escalation, and the conduct of the clinical trial”.
The new draft guidelines, which are open to public consultation until February 28th 2017 aim state that :
This revised guideline aims to address the increasing complexity of protocols of first-in-human clinical trials in recent years. While the 2007 guideline focused on the single-ascending-dose design used at that time, 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).
The revised EMA guidelines aim to assist sponsors with non-clinical and clinical testing strategies and designs for first-in-human trials and early phase trials. The revision of the EMA guidelines follows a review of the guideline after a Phase 1 first-in-human trial resulted in the death of a patient in France earlier this year.
The EMA aims to publish the final guideline in the first half of 2017 and it has stated that it will release all public comments relating to the revised guidelines document.