Recently, the United States Department of Health and Human Services and the National Institute of Health (NIH) issued two proposed rulings that may have a profound impact on how results of clinical trials are made more transparent to the public. However, before we discuss these proposals, we should discuss briefly how the public has access to clinical trials.
ClinicalTrials.gov is a website that is maintained by the United States National Library of Medicine, a part of the National Institute of Health. This website was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA) in an effort to provide a listing of federally and privately funded clinical trials. This listing was expanded with the Food and Drug Administration Amendments Act (FDAAA) in 2007 to encompass an even more comprehensive list of clinical trials under this umbrella.
One result from these acts is that informed consents for applicable clinical trials initiated on or after March 7, 2012 include the following statement:
“A description of this clinical trial will be available on www.clinicaltrials.gov as required by U.S. law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
Prior to the recently proposed rulings, an individual that logs on to the clinical trials website would be able to uncover the following information:
- Summary of the purpose of the study
- Recruiting status
- Disease or condition and medical product under study
- Research study design
- Phase of the trial
- Criteria for participation
- Location of the trial and contact information
However, since its conception, the website has encompassed clinical trials that do not fall under FDA Amendments Act. With these proposed rulings, the FDA Commissioner Margaret A. Hamburg, M.D. stated that “this proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices and biological products available to the public” in order to “help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products”.
So with this information let’s get down to the meat and potatoes of the proposed rulings:
- A streamlined approach for determining which trials are subject to the proposed regulations and who is responsible for submitting required information
- Expansion of the set of trials subject to summary results reporting to include trials of unapproved products
- Additional data elements that must be provided at the time of registration (not later than 21 days after enrolling the first participant) and results submission (generally not later than 12 months after completion)
- Clarified procedures for delaying results submission when studying an unapproved, unlicensed, or uncleared product or new use of a previously approved, licensed, or cleared product, and for requesting extensions to the results submission deadline for good cause
- More rapid updating of several data elements to help ensure that users of ClinicalTrials.gov have access to accurate, up-to-date information about important aspects of a clinical trial
- Procedures for timely corrections to any errors discovered by the responsible party or by the Agency as it processes submissions prior to posting
There is much more to this ruling and how it would impact clinical trials, and I would suggest reviewing the press release in further detail. Since this is a “proposed” ruling there is still room for suggestion and amendment; with these suggestions comes the opportunity to voice your opinion and offer your insight.
It will be very interesting to see how the final ruling compares to what was recently proposed. Going forward, how do you think these proposed suggestions will impact future clinical trial participation? Do you think that increased transparency of results will lead to increased or decreased clinical trial enrollment? Furthermore, what impact do you think the presence of the clinical trial website itself offers on subject involvement in a clinical trial?
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