France to Impose Stricter Regulations on Clinical Trials Following Deaths

France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others.

French health minister Marisol Touraine announced a four-point action plan Monday to strengthen the French National Agency for Medicines and Health Products Safety’s (ANSM) controls on clinical trials.

The plan is based on 19 recommendations made in a report by France’s social affairs inspectorate concerning a disastrous Phase 1 trial conducted by Biotrial testing Bial’s endocannabinoid-targeted candidate for mood and anxiety disorders (DID, Jan. 19).

Touraine is recommending that:

  • ANSM inspect all authorized research centers before the end of the year;
  • European regulators work toward better harmonizing procedures to assess serious adverse events similar to those encountered in Biotrial’s Phase 1 clinical trial;
  • Biotrial submit an action plan within the month on how to prevent similar adverse events in the future; and
  • An independent examination of clinical records for the 90 patients participating in the trial be conducted.

If the company does not provide the action plan, French authorities are threatening action.

Biotrial responded by blasting the recommendations, stating that it created and implemented an action plan after communicating with ANSM and ARS in January. The company said it will submit that action plan in response to French demands.

In the release, Biotrial also assigns blame to Bial for the adverse reactions due to the “unpredictable toxicity” of the Portuguese company’s compound, and not for any failure on its part.

According to a February IGAS report, Biotrial failed to notify French authorities when the first patient was hospitalized on Jan. 10, waiting until Jan. 14 to inform French health officials. In February, the Phase 1 trial prompted a collaborative investigation among French authorities, the EMA and the FDA.

Read the final IGAS report in French here: www.fdanews.com/05-23-16-IGASReport.pdf. — José Vasquez

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