Dear Director Collins and Director Brennan
February 21, 2017
Dr. Francis S. Collins
Director, National Institutes of Health
Dr. Patricia Flatley Brennan
Director, National Library of Medicine
Re: Section 2054, 21st Century Cures Act/ClinicalTrials.gov
Dear Director Collins and Director Brennan:
The undersigned organizations share a commitment to heightening clinical trial awareness, increasing clinical trial participation and promoting safety, quality and efficiency throughout the clinical research process. We greatly appreciate your efforts to improve the functionality, utility and usability of the ClinicalTrials.gov database for the benefit of patients, researchers and other interested parties. The Final Rule issued September 16, 2016 (42 CFR Part 11, Docket Number NIH-2011-0003) addressed many of the shortcomings of the database and rendered moot several provisions included in early versions of the landmark 21st Century Cures Act.
We note with interest, however, that Section 2054 of the 21st Century Cures Act requires NIH to consult with stakeholders including relevant Federal agencies, such as the Food and Drug Administration and the Office of the National Coordinator for Health Information Technology, as well as patients, researchers, physicians, industry representatives and developers of health information technology to receive recommendations to further enhance ClinicalTrials.gov.
The Act directs that the consultation take place not later than 90 days after date of enactment, which would be by March 13, 2017.
We appreciate that we are in a period of transition and that the NIH has many new responsibilities placed on it by 21st Century Cures. Nevertheless, we are writing to strongly encourage you to adhere to this timeline for the benefit of patients everywhere who are awaiting new treatments and cures.
Thank you for your consideration.
Association of Clinical Research Organizations (ACRO)
Association of Clinical Research Professionals (ACRP)
Society for Clinical Research Sites (SCRS)
Coalition for Clinical Trials Awareness (CCTA)
The Center for Information and Study on Clinical Research Participation (CISCRP)