“Biotrial the laboratory, who led the fatal clinical trial in Rennes, committed “three major shortcomings,” the final report of the General Inspectorate of Social Affairs (IGAS), animal health, which confirms its preliminary findings February, according to news reports Sunday. “The mission considers that the responsibility for Biotrial (…) such as Bial laboratory trial sponsor, are engaged,” wrote Le Monde on its online edition, adding having obtained the final report.
“She blames Biotrial ‘three major shortcomings” in the conduct of the trial and Bial a’ delay information of the health authority ‘and a choice insufficiently cautious’ to move to the 50 mg dose in multiple ascending doses, “the paper said. The first “is the lack of research information in a timely manner on developments in the health status of the first volunteer.” The second “no confirmation of their consent to the other volunteers Monday, January 11, before administration of the product.” The third common to Bial and Biotrial: Disregarding the duty to inform without delay the competent health authority.
Biotrial has strongly disputed these findings Sunday in a statement, saying IGAS had breached the principle of contradiction. It further claims that the investigators tried to exert “pressure” on its staff. Finally, it regrets that the investigators did not record the hearings in the minutes. Finally, it “reserves the right to seek the French courts the nullity of the report.” For its part, Liberation, who also had access to the document notes that the National Security Agency of Medicines (ANSM) “is in large part cleared.” As in its preliminary report, IGAS believes that “there is no need to challenge the authorization” to conduct the test.”
“The Biotrial center must commit to better protect healthy volunteers after the fatal clinical trial in Rennes, today ordered the Health Minister, Marisol Touraine, at a press conference. “I demand that Biotrial provide a major action plan to ensure that the deficiencies observed will not happen again,” said the minister. “This action plan will put myself without delay,” she added.
The General Inspectorate of Social Affairs (IGAS), animal health, confirmed, in its final report issued four months after the accident, the three major deficiencies identified in its preliminary report in February. The first is the lack of time and information search time on the evolution of the first voluntary health. The second on the absence of confirmation of their consent to the other volunteers Monday, January 11, before the administration. The third, common to the Portuguese pharmaceutical company Bial and Rennes test center Biotrial, concerns having been slow to inform the health authorities.
“The Inspectors believe that the responsibility of the laboratory and Bial Biotrial is engaged in several ways,” said the minister who decided to resume “full” the recommendations of IGAS. Biotrial has its side yesterday strongly disputed these findings considering that IGAS had breached the principle of contradiction. It further claims that the investigators tried to exert “pressure” on its staff. He regretted that the investigators did not record the hearings in the minutes. Finally, it “reserves the right to seek the French courts the nullity of the report.” ”
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