France issues stricter rules for pharma trials
The French government took measures last week to lower the health risks to clinical trial participants following the final report regarding a phase 1 clinical trial that killed one person and hospitalized five others in January. France’s health minister Marisol Touraine presented a plan on Monday for stricter rules regarding human drug trials. The plan also requested the Rennes-based Biotrial CRO that conducted the trial to submit a “plan of action” within a month to explain how it will avoid a repeat of these or else lose its operating license.
The report, issued by France’s General Inspectorate of Social Affairs (IGAS), also calls on the government to “mobilize the international scientific community” to find out what went wrong and suggests a range of scientific approaches, such as testing whether the drug hits other brain targets than the intended one and a study of the potential toxicity of the compound’s metabolites. It concluded that Biotrial failed to properly manage the testing and found that they continued to administer the drug even after one patient was sent to the hospital, and failed to confirm patient consent before running the trial.
The report also announced several measures to improve safety and strengthening the response when a trial goes wrong. France’s Regional Health Agencies will be asked to carry out inspections at all clinical trial centers in the country, along with the National Agency for Medicines and Health Products Safety (ANSM).
From this, we could potentially see more trials regulations forthcoming as it has been reported that France will work with the European Commission and the European Medicines Agency to improve trial practices at an international level. In addition to the IGAS investigation, the affair is the subject of a separate judicial inquiry.
About the Author
Amy Sinclair is an Area Executive Vice President and member of firm’s Life Sciences Practice. She negotiates, implements and manages comprehensive insurance programs for a variety of clients, ranging from venture-backed start-up organizations up to publicly traded companies.