No One Cares if You Post or Not Post Results on Clinicaltrials.gov: Reports
[Thursday, January 23, 2020]
The law requiring sponsors of clinical trials to post results from their trials to the clinicaltrials.gov website is almost 13 years old but many sponsors don’t care to comply and the government agencies responsible to enforce this law, NIH and FDA, have no plans to compel the sponsors to do so. Ironically, many trials with non-compliant postings were sponsored and/or supported by NIH and major academic and government institutions. Industry sponsors have become more compliant since NIH announced its plans to enforce the law two years ago but government funded sponsors have shown no improvement in this regard. The reason seems to be that neither the enforcers nor the sponsors appreciate the importance of posting results on clinicaltrials.gov. Talking to several sponsors who failed to submit results to clinicaltrials.gov indicated that the responsible parties felt that results of their trials were readily available in peer reviewed literature and hence incorrectly assumed that publishing was sufficient for transparency for their trials. The law was written to plug the loophole of incorrect, inadequate and incomplete reporting of results from clinical trials. Many trials never get published in peer reviewed journals. Those that do get published contain partial reports of selected data due to space limitations in the journals and biased perspectives of the authors. Clinicaltrials.gov, on the other hand, offers a standardized presentation of complete results. Independent investigations could not find any reasonable justification from NIH or FDA for lax enforcement. The law imposes a fine of about $12,000 per day for non-compliance, and so far, not a single violator has been fined anything. In that regards, NIH and FDA are perhaps the only government agencies that do not want to collect a fine from violators of laws they enforce. There does not seem to be any intent from NIH or FDA to change this. Both Agencies have publicly feigned lack of resources and lack of non-public information for non-enforcement. However, these excuses fall flat in the light of extensive public data listing the violators and specific cases. By some estimates the Agencies could collect billions of dollars in fines which, in turn, could pay for such efforts, although the moment laws start getting enforced, the violations will likely disappear. The problem is not with the law but with the Agencies who were tasked with assuring compliance but have completely failed to do their job, in this regard. For now, if you have not posted the results of your trial on clinicaltrials.gov, you can rest easy, nobody cares if you don’t.