EMA to make Phase I safer

In an EU-wide review on the first-in-human clinical trial guidelines, the EMA plans to identify any areas that will need revision following the death of a man participating in a trial in Rennes, France earlier this year. In January, the trial for a drug developed by Portuguese pharma company Bial, carried out by French CRO Biotrial, resulted in the death of one of the volunteers, and neurological damage – likely long-term in five others (http://www.european-biotechnology-news.com/news/news/2016-01/death-in-phase-i.html). Biotrial came under fire by investigators for “major shortcomings”. While a final report commissioned by the French Agency for the Safety of Health Products (ANSM) states that the death was probably caused by the drug’s toxicity and not by any violation of the rules, the authors did criticise a lack of common sense in the proceedings and recommended changes to the regulations and international best practice.

The EMA draws on the report by ANSM as well as another in-depth investigation by the Inspection générale des affaires sociales (IGAS), the inspectorate for social affairs in France. Both reports include a series of recommendations regarding the requirements for authorisation and conduct of first-in-human clinical trials for further examination by the international regulatory and public health community. By July, a concept paper identifying areas for change and proposals to minimalise risk in trials such as the one in Rennes. The concept paper will form the basis for an EU-wide review of the guidelines. This process will include targeted discussions with stakeholders and a public consultation on proposed changes later in 2016.