“There are units that are doing first-in-human studies that frankly have no business doing them”
DIA: Calls for set standards in Phase I studies following Bial trial tragedy
The Phase I clinical trial which left one patient dead and five with serious health problems earlier this year was conducted by French CRO Biotrial on behalf of Portugese drug firm Bial, and was the subject of a panel discussion at this year’s DIA in Philadelphia, Pennsylvania.
Our sister publication Outsourcing-Pharma.com was among the delegates (see full story here), and according to the University of Wisconsin-Madison’s Mary Westrick, current regulations do not have set standards for first-in-human clinical trials.
“CRUs [clinical research units] are built to hotel or dormitory standards,” she told delegates. “There are units that are doing first-in-human studies that frankly have no business doing them.”
Often these units are off-shoots of a practicing physician running a CRU in conjunction with his or her practice, Westrick - who until recently served as VP of Phase I trials at Quintiles – added. And in many countries, including the US, there are no accreditations or standards for entities conducting such trials.
However, implementing such standards may be easier said than done, as industry still awaits more information as to what went wrong during the trial.
Regardless, “in the light of this tragedy we need to figure out what we can do to keep volunteers safer,” she added.
“One of the issues we need to understand in the Bial trial is why was the remainder of the cohort dosed after one patient was admitted to the hospital? Did the CRU even call in to see test results from the patient?” Westrick asked.
“Every single adverse event needs to be considered drug related unless proven otherwise.”
A manslaughter investigation in connection with the Bial trial is currently underway.
And in related news, Californian drugmaker Regulus announced this week it received verbal notice from the US FDA that its candidate RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on clinical hold after the firm reported a second serious adverse event during a Phase I study.
Correction: The original article stated Mary Westrick is VP of Phase I trials at Quintiles, but in April this year she retired from the company
