- The U.K. Royal Statistical Society has raised serious reservations about the study design of the deadly phase 1 trial in France which resulted in six patient hospitalizations and one death.
- The RSS requested the Portuguese company Bial, whose drug was being studied in France, publish the investigator's brochure for the trial and the escalated-dose levels actually tested. The trial protocol was already published by French regulatory officials after it was leaked in the French press.
- The RSS also indicated the trial failed to follow recommendations it made after a separate 2007 clinical trial resulted in six hospitalizations.
Although Bial has refused to release the Investigational Product Dossier and the Investigator's Brochure, the pressure from the RSS and the regulatory communities is not going away—especially now that RSS has flagged concerns about clinical trial design and proper risk assessment.
The RSS also requested Bial release information about the regimen used for the first cohort tested in the multiple-dose phase.
This controversy extends well beyond the borders of France and has been a wake-up call for many clinical trial investigators. Statisticians and others involved in pharmacology worldwide are starting to weigh in on clinical trial safety. For example, the British Pharmacological Society issued a statement calling for improved early access to data from trials that go wrong and have catastrophic outcomes.
Bial is claiming confidentiality surrounding its trade secrets as its reason to not release the additional documents to the public.