Why Do Academic Centers Fail at Timely Submitting Results to Clinicaltrials.gov?
​[Thursday, February 06, 2020]
Several recent reports have pointed out that while the industry has become increasingly compliant with submitting results of clinical trials to clinicaltrials.gov, the academic centers are way behind. A new reports highlights that it is primarily due to lack of resources and support available to academic centers for doing the same. Posting results to clinicaltrials.gov have been a requirement for more than 10 years but it is one of the least enforced laws by the FDA and NIH. One of the key reasons for the lack of enforcement is that there is no clear regulatory body in charge of enforcement. While NIH maintains and controls the clinicaltrials.gov website content, FDA regulates clinical trials the results of which will need to be posted. Both agencies have frequently passed the buck to the other for the responsibility to assure compliance. Meanwhile, non-compliance is rampant. Ironically, NIH funded clinical trials were found to have the highest rate of non-compliance with regards to posting results. A recent review discussed the reasons for non-timely submission of clinical trial results by one such institution, John Hopkins University. The authors pointed out two reasons why John Hopkins University researchers could not post results of their trials on time. First, researchers at the university are not adequately incentivized or provided resources to submit results to clinicaltrials.gov. Many believed, probably based more on perceptions less on efforts, that the format requirements for clinicaltrials.gov were too strict and complicated making it hard to recycle the result format and reports that they have available. To post results on clinicaltrials.gov require significant efforts to re-format the data and validate prior to submission. Incorrectly submitted results lead to multiple cycles of review, rejection and re-submission each adding to the cost and frustration of the submitters. Second reason is that the rejection received from NIH after posting results mostly only flags the errors but not offer meaningful feedback to correct, according to the researchers interviewed. This could be again a perception issue. Most researchers at academic centers probably expected to simply upload whatever format they had the results in. However, the clinicaltrials.gov staff is required to assure similar structure of all postings. The authors vaguely attributed this lack of compliance on leadership flaws at the academic centers. The case highlights a common problem seen in such academia versus industry comparisons. Similar complaints of limited resources and incentives are made for the quality of research data and GCP compliance of academic clinical trials. There is a big gap in the impact of academic versus industrial research in terms of clinical and medical applications. But if academic researchers want their experiments to get similar impact as industrial research one would expect the academic researchers to address this issue and allocate the needed resources. But maybe that’s asking too much.