Academic medical centers and transparency of trial results


Timely disclosure of trial results is a key element of clinical research "transparency", and under Section 801 of the FDAAA, this is not only an ethical argument, but a legal mandate. FDAAA sets a fairly reasonable bar for disclosing trial results within a year of study completion, and as pointed out by Joseph Ross of Yale, it's hard to argue that the law is impractical or unworkable. But compliance is not yet 100 percent, which begs the question: who "owns" the responsibility to disclose results? Pharma and device companies are clearly on the hook for studies they solely fund and execute - but this accounts for only some interventional trials. In many "industry-funded" studies, the company provides only medicine and/or financial support, and an academic investigator controls the data, analysis and reporting. In these cases, faculty and academic medical centers (AMCs) are wholly responsible for FDAAA adherence.

Sadly, AMCs are woefully unprepared to comply with this unfunded mandate. There's a high administrative burden to ensuring trial information in ClinicalTrials.gov is up to date, made more challenging by the somewhat clunky IT interface. And whereas pharma companies have devoted significant resources toward FDAAA compliance, AMCs have pushed this responsibility down to individual investigators, who often balk at spending time and effort on "administrative" tasks.

But lack of funding is not an excuse for inaction. AMCs and investigators must comply with FDAAA, no matter how flawed and burdensome its requirements may be. So the question is, how can AMCs drive transparency of trial results?

First, AMCs should clearly communicate reporting policies to their faculty. Not all AMCs appear to explicitly inform investigators of their need to comply with FDAAA rules on reporting results - and even at those that do, awareness of the regulations and the mechanics of how to comply are likely low. It would take relatively little effort for AMCs to update their policies in line with FDAAA and bolster their outreach efforts - for example, by incorporating education on results reporting into existing mandatory certification programs for clinical researchers.

Second, they should educate investigators on compliance mechanics. Helping academic investigators find the training resources that NIH and others (herehere, and here) have already developed on depositing data in ClinicalTrials.gov would be a great first step toward easing the administrative burden - and the cost to AMCs to disseminate this information would be negligible.

Third, they should collect and publicize compliance data. Anecdotal evidence suggests that many AMCs currently lack any idea of the baseline level of results disclosure in their institutions. Not only would collecting these data enable AMCs to track improvement over time, but publicizing the aggregate data could help raise awareness and drive reporting. Given that much of the information already exists (in ClinicalTrials.gov and internal Institutional Review Board (IRB) databases), the cost of collecting and analyzing the data would likely be low. (An idea for an AMC "hack-a-thon", perhaps?)

And finally, AMCs should link compliance to future IRB approval. Academic IRBs exist to protect human subjects and uphold ethical standards in clinical research, and results reporting clearly fits under that umbrella. It's hard to imagine why an academic investigator who is non-compliant with FDAAA regulations should be allowed to initiate another trial - and, in fact, NIH already sets this standard for new and renewed Federal grants. This requirement would certainly be a big "stick" to drive compliance, and would require only an IRB policy change, not additional administrative resources.

Academic researchers execute a large proportion of clinical studies for new medical agents - and thus bear much of the responsibility for ensuring that results are transparently disseminated. Just as pharma companies have invested resources to comply with FDAAA, leaders of AMCs can and should actively drive adherence to both legal and ethical standards in reporting the results from clinical trials.

Thanks to Joseph Ross and Jeff Flier for the helpful comments they provided during the preparation of this piece.