“I want to strengthen the conditions for authorizing trials, in particular for the first administration to humans“declared the Minister of Health Marisol Touraine on Monday, May 23, 2016, during a press conference. Following the accident in Rennes as part of a clinical trial that resulted in the death of one volunteer and hospitalization of five others, the minister has indeed commissioned a report from the General Inspectorate of Social Affairs (IGAS). This investigation highlights shortcomings on the part of the Bial laboratory and the company Biotrial with regard to crisis management and “the warning and protection of volunteers participating in trials of first administration to humans“. Consequently, Marisol Touraine has decided to put in place an action plan to better supervise clinical trials and”strengthen the responsiveness and follow-up of volunteers in the event of adverse events“.
Reassess the rules in France and in Europe
One of the flagship measures of this action plan is to strengthen the conditions under which the National Medicines Safety Agency (ANSM) assesses clinical trials. The ANSM will therefore have to apply stricter rules to examine the trials of the first administration to humans. These rules are, according to Marisol Touraine, “to be reassessed not only in France but also at European level“. Also, “it will not be a question of imposing a framework for all clinical trials but of defining a common framework for the various trials“she clarified.
A new unit dedicated to early testing
In addition, each Regional Health Agency (ARS) will have to inspect all centers authorized to conduct clinical trials in their region. In addition, the ANSM must send every month to the General Directorate of Health a report on adverse effects “serious and unexpected“observed for the phase 1 and 2 trials, which aim respectively to study the toxicity in healthy patients and to find the smallest effective dose in a small number of patients. To centralize the information and the decisions to be taken in the event of undesirable effects, the Minister finally wishes to set up a specific unit “dedicated to early testing“within the ANSM. This new organization should make it possible to react more quickly, more effectively and more easily if side effects considered as “new facts“occur in early trials.
Case to be followed for the Rennes clinical trial
Regarding the clinical trial in Rennes, legal proceedings are underway and the Ministry of Health has ordered an independent health expertise by the Temporary Specialized Scientific Committee (CSST) to assess the files of the 90 healthy volunteers. On May 13, MRI scans on participants showed thatone of the volunteers had already suffered a stroke(Stroke). Marisol Touraine also asked Biotrial to give her an action plan within a month with “an upgrade of the conditions for monitoring research participants, and the strengthening of the training of its staff“, otherwise his authorization for a research site for a phase 1 trial will be suspended.
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