Report outlines FDA disregard for trial conflicts

The FDA does next to nothing to explore potential conflicts of interest among the providers involved in clinical trials and believes that protecting patients from such conflicts doesn't warrant the effort.

That was the conclusion of a new report out from the inspector general's office of HHS, which found that in close to half of all trials the agency never received forms covering possible conflicts from doctors and never tried to get them. And in a third of the cases where they did get the information, the agency never bothered to document if it read the reports.

The agency does not have a list of clinical trial investigators, so it has no way of knowing if they ever filed a form. And the report also reveals that only one percent of the forms on file reflect a significant conflict of interest, compared to studies that show up to a third of all clinical investigators have a conflict.

Don't expect any sudden change of behavior at the FDA, though. A spokesperson told the New York Times that the agency doesn't favor getting the data because it reflects just one potential bias.

- read the article [1] from the New York Times

Related Articles:
December FDA news in review [2]
FDA advisors face conflict cap [3]
FDA grapples with new conflict rules [4]
FDA to disclose advisors' financial ties [5]