France Tightens Rules After Fatal Clinical Drug Trial
25 May 2016, 6:09 am EDT By Katherine Derla Tech Times
French regional authorities will inspect medical centers across the country to ensure they meet the standards for clinical trials. This follows the aftermath of a clinical drug study that went horribly wrong in January wherein one participant died. ( Jacqueline Macou | Pixabay )
In the aftermath of a fatal clinical drug trial, the French Health Ministry instructed regional authorities across the country to conduct inspections on every authorized medical center. This will ensure that the centers meet the standards set for drug trials.
In January, a clinical drug trial in France went horribly wrong. One study participant died while five others ended up in the hospital. Now, the French Health Ministry found two companies were at fault for the fatal drug test.
Based on the newly released investigation report by the General Inspectorate of Social Affairs (IGAS), the five hospitalized participants have been dismissed.
They were part of the 128-participant study who took BIA 10-2474, a painkiller developed by Portuguese drug company Bial.
BIA 10-2474 targets the endogenous cannabinoid system, which is part of the human body's pain management system. The drug is designed to treat motor disorders as well as anxiety.
The trial was conducted by French company Biotrial at a private hospital in Rennes, Brittany. During the clinical trial, BIA 10-2474 was given to the participants under doctors' supervision.
While the French-authorized trial conditions were followed, the investigation found that the two companies failed "on several counts."
The two companies failed to give the right drug amount to the study participants. It also took them long to inform the French government and the other participants about the problems.
The life-threatening side effects started in the group that were given several 50 milligrams daily doses. The participants who previously received either one-time doses of up to 100 milligrams or several doses of up to 20 milligrams did not experience any dangerous consequences arising from the drug intake.
The major mistakes started after the hospitalization of a 49-year-old participant on Jan. 10. The participant suffered from blurry vision and headaches, then eventually died.
The trial continued and the participants received another round of drug doses the following morning. They were not informed of what happened to their co-participant. Moreover, Biotrial only alerted the government authorities on Jan. 14.
The Phase 1 study has been put on hold. The French authorities will give the two companies one month to submit an action plan guaranteeing that no similar issues will arise in subsequent trials. Otherwise, the two companies risk getting suspended.
The IGAS report (PDF) also mentioned the possibility of a separate judicial review. The volunteers' health records will be continuously investigated. A separate authority will relay the health information to the European Commission.
In the aftermath of a fatal clinical drug trial, the French Health Ministry instructed regional authorities across the country to conduct inspections on every authorized medical center. This will ensure that the centers meet the standards set for drug trials.
In January, a clinical drug trial in France went horribly wrong. One study participant died while five others ended up in the hospital. Now, the French Health Ministry found two companies were at fault for the fatal drug test.
Based on the newly released investigation report by the General Inspectorate of Social Affairs (IGAS), the five hospitalized participants have been dismissed.
They were part of the 128-participant study who took BIA 10-2474, a painkiller developed by Portuguese drug company Bial.
BIA 10-2474 targets the endogenous cannabinoid system, which is part of the human body's pain management system. The drug is designed to treat motor disorders as well as anxiety.
The trial was conducted by French company Biotrial at a private hospital in Rennes, Brittany. During the clinical trial, BIA 10-2474 was given to the participants under doctors' supervision.
While the French-authorized trial conditions were followed, the investigation found that the two companies failed "on several counts."
The two companies failed to give the right drug amount to the study participants. It also took them long to inform the French government and the other participants about the problems.
The life-threatening side effects started in the group that were given several 50 milligrams daily doses. The participants who previously received either one-time doses of up to 100 milligrams or several doses of up to 20 milligrams did not experience any dangerous consequences arising from the drug intake.
The major mistakes started after the hospitalization of a 49-year-old participant on Jan. 10. The participant suffered from blurry vision and headaches, then eventually died.
The trial continued and the participants received another round of drug doses the following morning. They were not informed of what happened to their co-participant. Moreover, Biotrial only alerted the government authorities on Jan. 14.
The Phase 1 study has been put on hold. The French authorities will give the two companies one month to submit an action plan guaranteeing that no similar issues will arise in subsequent trials. Otherwise, the two companies risk getting suspended.
The IGAS report (PDF) also mentioned the possibility of a separate judicial review. The volunteers' health records will be continuously investigated. A separate authority will relay the health information to the European Commission.
