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A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants enrolling in clinical trials can make informed decisions about trial participation and know how their participation may have helped others. Clinicians benefit by knowing about trials in which their patients might participate, having a more complete evidence base for decision-making, and seeing potential new treatments as they emerge. And for you, the research community, you can take timely information about clinical trial findings, be they positive or negative, to guide future research toward the next great innovation in health. We believe strongly that we have an obligation to share clinical trial information widely and in a way that both protects participant privacy and accelerates scientific discovery. Thus we are taking important steps to advance the sharing of clinical trial results.

Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. This Notice of Proposed Rule Making (NPRM) further clarifies clinical researchers’ requirements under FDAAA for clinical trials that meet the legal definition of an “applicable clinical trial,” including interventional studies of drugs, biological products, and devices that are regulated by the FDA, but excluding phase 1 and feasibility studies. Additionally, it proposes some changes to the information that must be submitted to the ClinicalTrials.gov database. As described in the proposed rule, clinical trials registration and results information would include additional data elements to more fully capture the information necessary to understand the results of a trial, and, most significantly, information would be required for the results of clinical trials of products not yet approved by FDA. NIH has developed a summary of the key proposals of the NPRM, and this can be found on the NIH website. To understand all the proposed changes to current practice and get prepared to submit public comments, NIH recommends that you review the NPRM itself.

Importantly, today NIH also announced a proposal to apply these same proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that every NIH-funded clinical trial be registered in ClinicalTrials.gov and that summary results are posted to the database in a timely matter. This is important, since NIH funds trials beyond those that fall under the proposed regulation, and the inclusion of the other clinical trials as proposed in the new policy, will ensure that the results of all trials are widely disseminated and that this is done openly and promptly.

As described in the NIH Guide notice that came out this morning, we are encouraging the public to provide comments on any aspect of NIH’s draft policy as well as the proposed regulations published today in the Federal Register. Both documents are open for a 90-day public comment period, and comments will be taken into consideration before final regulations and a final NIH Policy are issued. Remember that while your comments on this blog are welcome in line with our blog policies, only comments submitted according to the instructions described in the Guide and Federal Register can be considered in the development of the final policies.

You might also find it helpful to review NIH’s recent guide notice on the revised definition of a clinical trial, to help ensure you are meeting your current obligations, and to help you understand what projects the proposed policy would affect. (Note that the revised clinical trial definition will apply to competing applications for the January 25, 2015, due date and subsequent due dates.)

Expanding the dissemination of NIH-funded clinical trial findings complements existing NIH policies to promote data sharing and public access to NIH-funded research results. Data sharing and transparency about publicly funded research protects the public’s trust in research and maximizes the value of NIH’s investment in research by allowing scientists to build upon existing results. And, as the title of NIH’s director’s blog states, it honors our promise to those who volunteer in clinical trials – that we are doing all that we can to further the impact of their valuable contribution to research to help others.

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One thought on “A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

  1. I can tell you that one upshot is that I expect I will NEVER again propose small NIH projects — about $300K direct budget and below — that have the faintest hint of clinical intervention in them, for any purpose.

    Why? Because NIH has already ruled that any new intervention (involving prospective assignment of subjects) is all it takes for a study to be considered a clinical trial. And now clinical trials have become heavyweight projects, requiring ClinicalTrials.gov management, even for studies that could previously be kept lightweight by virtue of no more than expedited IRB approvals and no FDA involvement.

    Consider the intervention of teaching stuttering persons to “sing” their words, when that was a new idea: soundly demonstrated on small numbers of subjects, with extremely low risk. And correspondingly tiny management effort for that research. Until now.

    NIH again lives up to its reputation, that all research is assumed to have high risk, requires rigid policies, is conducted in large organizations (with administrative staff than can amortize their extra training in their narrow administrative specialty across large projects or large numbers of small ones), and should be managed with bureaucracy. So be it.

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