Scrutinized FDA bars larger number of clinical trial investigators
The agency said that physicians and other clinical investigators who conduct the studies “are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety and welfare of those subjects.”
The FDA maintains the right to disqualify a clinical investigator if they have “repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to the FDA.” A disqualified clinical investigator is not eligible to receive investigational drugs, biologics or devices.
Among those banned this year, the most recent was Maria Anne Kirkman Campbell, MD, who pleaded guilty to fraud in 2003 in connection with a study of antibiotic telithromycin (Ketek) by Sanofi-Aventis. The trial included fabrication of data at one clinical site and allegations of data manipulation of data at another.
However, there are other classes of FDA restriction: “Totally restricted” investigators are ineligible to receive investigational products, while “restricted” investigators are still eligible to receive investigational products, provided they conduct regulated studies according to the restrictions specified in their agreement with the FDA.
In the case of Kirkman Campbell, the FDA classified the Alabama family practitioner as “totally restricted.”
Legislators, including Rep. Joe Barton, R-Texas, have criticized the agency for taking years in some cases to act against researchers after finding violations, according to Bloomberg. The doctors and clinical trial investigators are eligible to continue conducting studies for submission to the FDA until they are disqualified.
“Doing something is a good sign,” Barton told Bloomberg. Delays in banning researchers have allowed “people that do things that they shouldn't be doing to continue,” he said.
The FDA relies on the results of clinical trials to determine whether drugs and medical devices are safe and effective enough to clear for sale, Bloomberg reported. Delays in disciplining doctors who do not properly supervise the tests put patients at risk and threaten the validity of the studies.
Government investigators, including the Office of the Inspector General for the Health and Human Services Department, have found flaws in the FDA’s oversight of drug trials. The agency inspected less than 1 percent of 350,000 sites where drug trials were conducted from fiscal 2000 through 2005, according to a report released in September 2007 by the Inspector General.