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Compliance In Focus
Posted by Sandra Maddock on Wed, Nov 1, 2017

Final Rule for Clinical Trials Registration and Results Submission

Clinicaltrials.gov is a database of clinical research trials being conducted both in the United clinicaltrials.gov.jpgStates and internationally and is intended to be a resource for patients and researchers alike. Housed by the United States National Library of Medicine, clinicaltrials.gov currently has postings for over 257,000 clinical studies that are being conducted in over 200 countries. On January 18, 2018, the “Final Rule for Clinical Trials Registration and Results Submission” will go into effect. This rule provides further clarification on the “What, How, and When” of clinical trial reporting requirements.

According to this article, compliance with reporting outcomes results has been low, so this final rule will help address that and provide a mechanism by which timelines can be enforced. It will also provide results data that would be available not only to researchers, but to the patients who participated in the trials. 

Is this going to be difficult for sponsors to do? To what would low compliance be attributed? Is it that they are publishing their results in other forums (i.e., peer reviewed journals) and overlooking the requirement to update their information on clinicaltrials.gov? Is it related to proprietary information? Or maybe if the results are negative, are they worried about potential implications from the research subjects? Is it a resources issue? Just not enough people to deal with the next project let alone follow-up on the previous one?

Regardless of the reason, I would imagine that between now and January, industry is tasking someone internally to revise their clinicaltrials.gov policy to align with this new update as enforcement is around the corner. I’m curious how your companies currently handle this and whether or not this update will be difficult.

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photo credit: Gwenaël Piaser Tristan via photopin (license)

Topics: Clinical Studies, FDA, clinicaltrials.gov


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