A US HHS report on FDA oversight during trials has found that, with current procedures, the agency cannot tell whether drugmakers are disclosing complete financial information from all investigators who worked on a particular study.
The concern is that the Food and Drug Administration's (FDA) inability to monitor this information opens up the trials process to, at best, criticism for a lack of transparency and, at worst, bias, a loss of data integrity and potential risk to patient health.
Yesterday’s report, which analysed 118 trials cleared by the FDA in 2007, revealed that 42 per cent of study applications included in the research were lacking full financial information.
The study also found that in 31 per cent of trials where full disclosure did take place FDA staff had failed to document reviewing this information. Additionally in 20 per cent of cases where potential financial conflicts were identified the agency took no action to resolve them.
While critical of the FDA, the Department for Health and Human Services (HHS) conceded that the agency had been placed in a difficult position by the a loophole in the rules governing trials which, despite being introduced in 1999, are still not being properly enforced.
At present drugmakers are required to collect financial information before studies can begin, but do not need to submit it to the FDA until marketing approval is sought long after the study process is completed.
In addition, trial sponsors can bypass the submission if they prove they used due diligence while trying to obtain the data, regardless of whether they are able to obtain the data or not. In the report the HHS noted that 28 per cent of the applications had successfully sought this exemption.
The HHS said that the FDA should develop a complete list of investigators as a reference to check that complete financial submission has been carried out for all staff people working on a trial.
It also recommended that a review of financial information be included in onsite pre-trial assessment and that the FDA provide further clarification on the use of the due diligence exemption.
Karen Riley, a spokeswoman for the FDA, told the New York Times that the agency opposes reviewing investigators financial information for potential conflicts before trials on the basis that they represent just one possible source of bias. The agency is concerned that such reviews applied to all trials would be a wasted effort because not data from clinical trials is presented in a trial application.
The HHS inspector general countered that in undertaking such reviews the FDA would collate data on all possible sources of bias allowing it to work more effectively with drugmakers to eliminate any skewing of clinical data. The HHS added that such measures would be more in keeping with the FDA’s stated aim of “improving oversight in ongoing clinical trials.”
The FDA is not the only agency to have been criticised by the HHS for its protocols for removing bias. A similar study last year revealed that the National Institutes of Health (NIH) do not police potential financial conflicts involving academics involved in studies. At the time the NIH said that it was opposed to carrying out these checks.