Public release date: 13-Jan-2009
– 42% were missing the required financial disclosures on the investigators.
– Most often, the sponsors said the investigators could not be located or failed to return the financial form.
– The OIG’s investigation revealed that among forms filed for 29,691 clinical investigators, only 206 — less than 1% — indicated at least one financial interest, contrasting sharply with independent estimates.
– The FDA opposes requiring investigator disclosures as part of the pre-trial process
By Emily P. Walker, Washington Correspondent, MedPage Today
WASHINGTON, Jan. 12 — The FDA fails to ensure that scientists conducting clinical trials on investigational products disclose financial conflicts of interest, found a review by the Department of Health and Human Services.
An analysis by the Office of Inspector General (OIG), covering all 118 marketing applications for products approved by the FDA in 2007, showed that 42% were missing the required financial disclosures on the investigators.
“Financial relationships between researchers and medical companies may compromise the safety of human subjects and the integrity of research data,” the OIG report said.
The report recommended that trial sponsors submit financial disclosures as part of the pre-trial process, rather than after the trial’s completion.
For every study submitted to the FDA as part of a marketing application, the agency’s regulations require sponsors to submit financial disclosure information on each investigator.
Sponsors have the option of not including financial information if they tried and failed to obtain it. The report found that more than one-quarter of the marketing applications used that “due diligence” exemption. Most often, the sponsors said the investigators could not be located or failed to return the financial form.
For those marketing applications that disclosed financial conflicts of interest, FDA reviewers and sponsors failed to take action to remedy the conflict in 20% of all cases, the report said.
For about one-third of all marketing applications, FDA reviewers didn’t even document that they checked the financial disclosure.
“If FDA reviewers fail to document a review, division directors may overlook disclosed financial interests and their potential impact on data integrity,” the report said.
Even when disclosure forms were filed, the number reporting potential conflicts was surprisingly low.
The OIG’s investigation revealed that among forms filed for 29,691 clinical investigators, only 206 — less than 1% — indicated at least one financial interest, contrasting sharply with independent estimates.
For example, a figure of one-quarter of academic researchers having financial ties to medical companies was published last year in the Journal of the American Medical Association, the report noted.
The OIG recommended that the FDA compile a central list of clinical investigators and their financial disclosures in order to accurately and easily look for conflicts of interest for future trials.
In addition, the FDA should check that sponsors have submitted all required attachment and financial forms along with their marketing applications, and it should update guidance on the due diligence exemption, the report said.
FDA spokeswoman Karen Riley said in a statement that the recommendations were reasonable, with one exception.
The agency opposes requiring investigator disclosures as part of the pre-trial process, she said.
“This recommendation could have the unintended effect of adding to the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of the data,” Riley said.
She argued that a pre-trial submission requirement could create significant unnecessary paperwork, since data from a given study “may never be submitted in support of a marketing application.”
Riley said clinical investigators’ financial incentives are only one type of bias that might exist in a trial. She said it has not been established that increasing the level or frequency of disclosure “would solve a recognized problem or enhance subject protection.”
The agency takes at face value the OIG’s finding that fewer than 1% of investigators reported potential conflicts, according to Riley.
On that basis, Riley said, as well as the fact that only 8% of products entering phase I testing eventually gain final approval, “restructuring FDA’s review process to accommodate this recommendation does not seem warranted.”
Additional source: Office of the Inspector General in the Department of Health and Human Services