FDA oversight of clinical researchers’ financial conflicts found to be lax
The U.S. Food and Drug Administration’s (FDA) does a poor job tracking the financial conflicts of interests researchers who test drugs and medical devices on human subjects, according to an investigation by the Office of the Inspector General of the Department of Health and Human Service (DHHS).
Most drugs and medical devices used to treat patients must undergo testing in human subjects to show that they are both safe and effective before being approved for marketing.
Under U.S. regulations, the sponsors of these clinical trials, usually pharmaceutical and medical device companies, are required to collect information about any financial conflicts of interests the researchers conducting the trials might have and submit them to the FDA.
In addition, for each financial conflict identified, the companies must explain how they sought to minimize the possibility that the conflict might influence the researcher’s judgement, biasing the trial results.
These reports must be submitted to the FDA when the drug or device is submitted for approval, usually long after the trial has been conducted.
However, the companies have an out: the regulations allow them to claim they exercised due diligence but were unable to obtain the information.
To determine how well the system was doing at tracking and addressing these conflicts of interest, the DHHS’s Office of Inspector General reviewed 118 applications for new drugs or devices that had been approved by the FDA.
The investigators found that only 1 percent of the researchers were reported having at least one conflict of interest.
“This represents 206 of the 29,691 clinical investigators listed in the financial interest forms,” says the report released today by the Office of the Inspector General.
The investigation also found that FDA officials were not able to tell whether the sponsors had submitted financial information for all the researchers because the agency did not have a complete list of the researchers nor did agency’s officials do onsite inspections to see if the submitted financial disclosure information was complete.
Forty-two percent the applications were missing financial information, the report says, and in 31 percent of cases FDA officials did not document that they had reviewed the financial information.
In those instances where financial conflicts of interest were identify only 20 percent of the time was there evidence that the FDA or the trial’s sponsors had taken action to minimize the risk of bias as required by regulations.
The report recommends that the FDA ensure that sponsors submit complete financial information for all the clinical researchers, that FDA reviewers consistently review that information and take action when there conflicts are identified, and that sponsors be required to submit the financial information of investigators before the trial, not after, as is currently done.
To learn more:
- Read the full report by the Office of the Inspector General.
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