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Proposed Rule Calls for Posting of Study Results on ClinicalTrials.gov, Even for Products that Aren’t Approved

March 9, 2015 | Hazar Awad Granko, RPh, PhD, Director, Regulatory Affairs | Regulatory Affairs

The National Institutes of Health (NIH) recently extended the comment period for its Notice of Proposed Rulemaking (NPRM) on expanded clinical trial registration and results submission to March 23, 2015.

This proposed rule would have a significant impact on reporting requirements for clinical studies of products that are not yet approved by FDA.

Background
Since passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Sponsors of certain clinical trials have been required to post study results on ClinicalTrials.gov. Currently, however, study Sponsors can delay posting study results until after their drug has been approved by the FDA.

But if NIH’s proposed rule goes into effect, this will change. The NPRM proposes numerous changes to the way in which clinical trial results are recorded and reported on ClinicalTrials.gov.

Drug not approved? Report anyway
The most significant and impactful change being proposed by the NPRM is to extend the requirement for submission of results information to ClinicalTrials.gov for applicable clinical trials of products that are not yet approved or cleared by the FDA.

The NIH cites numerous public health benefits in their rationale for this proposal, including:

  • mitigating the bias in information available to the public
  • helping protect the safety of clinical trial participants by reducing the likelihood for unnecessary trials or those that evaluate interventions that may be potentially harmful or ineffective
  • allowing patients to make more informed decisions about participating in a clinical trial
  • broadening the evidence base for systematic reviewers and others involved in assessing the benefits and harms of classes of drugs and devices
  • ensuring that the knowledge that is obtained in clinical trials will be available for use in advancing biomedical science

This new requirement is proposed to apply regardless of whether the product is being sought for approval or is ultimately approved and will, therefore, require reporting of results of failed clinical trials or clinical trials that are part of an abandoned clinical program.

Delayed reporting
In response to the noted concerns about commercial competitiveness resulting from disclosure of results of clinical trials of unapproved products, the NPRM incorporates an allowance for a one‑time delay of results submission of up to 2 years after the 1-year results due date (equivalent to 3 years from the trial completion date).

In order to qualify for the delay, the Sponsor must certify that the product is being, or may at a future date be, sought for approval and must submit the request for the delay prior to the results submission deadline for the trial.

The NIH argues that 3 years “would provide sponsors with significant lead time in product development over potential competitors.”

Effective date
Once the final rule is issued, the effective date of these regulations will be established as 45 days after the date on which the final rule is published in the Federal Register and the compliance date will be 90 days thereafter.

The requirements will apply to clinical trials that are initiated on or after the effective date or are ongoing as of the effective date.

Comment period extended
The proposed rule was published on November 21, 2014 with an original deadline for public comments of February 19, 2015. The comment period has now been extended to March 23, 2015. As of the writing of this post, the NIH has received over 650 comments on the NPRM.

Regulations

Want to comment? Now is your chance!
Comments on the NPRM can be submitted via www.regulations.gov under Docket Number NIH–2011–0003 until March 23, 2015.

Click here to read more about this and other changes being proposed in the extensive 116‑page NPRM document.

Need Help?
IMPACT’s team of highly experienced regulatory experts and medical writers and can help you make sense of the ClinicalTrials.gov reporting requirements and prepare fully compliant clinical trial results summaries for submission. Send us an email  or give us a call today at (919) 899‑9248.

Category: Regulatory Affairs
Keywords: clinical trials, registry, ClinicalTrials.gov, NIH, FDA, proposed rule, Federal Register

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