A Patch? YES – A Fix? NO: This Emperor Has No Clothes

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The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in prior blogs).

The main issue has always been that trial results were provided much too late or worse, not at all. Even in the absence of a publication, society and patients are entitled to learn about trial results, and Clinicaltrials.gov is meant to be the repository of this information.

There is simply no excuse for the lackadaisical way this database is currently administered (the word ‘maintained’ would be too kind) and the shoddy oversight that let companies and organisations skirt their regulatory responsibilities.

We are quick to assume sinister motives when favorable study results are publicized expeditiously but others are not. Selective reporting and preferential push of publication with ‘good’ results takes on all kinds of forms but Clinicaltrials.gov should be above the fray: a neutral source of core information after the data has been cleaned and analyzed. Just the facts, please!  No spin-doctoring, no framing.

There has always been a federal mandate to provide trial information as much as there was a mandate to register a trial in the first place. Have you ever heard of regulatory action against a delinquent company or institution that kept study results unpublished for years after trial completion? There is not a single such case since Clinicaltrials.gov came into existence (around 2003). The 600+ pages of the new Rule dutifully provide references for this sad state of regulatory oversight and major lack of compliance. At the end one does not know whom to blame more: the sheep for trashing up the place or the shepherd for not wielding a stick.

The new 2016 Rule it a blunt weapon unlikely to generate better compliance.

Well, the new Rule has a new Section 11.66 which describes the penalties for non-compliance. Most of the punitive action is reserved for submitting false information and for non-compliance with submitting “Clinical Trial Information”. Please note: Summary results information is a part of Clinical Trial Information and as such was a required deliverable since 2008 already.

If non-compliance, i.e., not submitting study results as part of “Clinical Trial Information” is a punishable offense, why are we where we are? With the threat of penalties already in the 2008 Rule; repeating the same threats for non-compliance and hoping for a different outcome seems illogical.

The Rule deals with a lot more than just results reporting, for sure, but the main thrust should still be:  Show us the study result data, STUPID!

We believe Clinicaltrials.gov should run like a well-greased engine, well-maintained by study sponsors, monitored for compliance by HHS / NIH. There need to be significant consequences for non-compliance, nothing else will do. Let’s not continue the indifferent laid-back approach which was in place far too long.

Hey FDA, this could become your next self-funding tool!  The charges for non-compliance could easily pay for your new headcount to administer Clinicaltrials.gov (and some more).

 

References:
[1] RIN: 0925-AA55: Clinical Trials Registration and Results Information Submission. Final Rule. This document is scheduled to be published in the Federal Register on 09/21/2016 and available online at https://federalregister.gov/d/2016-22129, and on FDsys.gov

 

 

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