IC Directors' Meeting Highlights
December 22, 2005
I. Registration of NIH-Sponsored Clinical Trials
Dr. Lindberg updated the group on the status of ClinicalTrials.Gov, noting that it has been a big success under the 1997 Food and Drug Administration Modernization Act (FDAMA), which required the NIH to establish a registry of clinical trials for both federally and privately funded trials of experimental treatments for serious or life-threatening diseases. However, he stressed that potential legislation, the Fair Access to Clinical Trials Act (FACT) of 2005, would enforce against any non-compliance with registration.
While NIH Institutes have strongly supported, helped, and advised Clinical Trials.Gov, Dr. Lindberg pointed out areas that must be improved in order to comply fully, the most important being that a number of NIH trials are not registered and the status of the trials are frequently inaccurate. He also pointed out occasions on which ICs issued press releases on clinical resource results where the clinical trial has not been posted on ClinicalTrials.Gov. He urged that all ICs work together to ensure nothing less than perfect and consistent compliance by NIH. Dr. Lindberg also raised other areas requiring discussion, such as the need for trial numbering.
The group then offered suggestions for ways to ensure that the posting of NIH-conducted and -supported research is consistent and complete. Finally, Dr. Zerhouni asked Dr. Lindberg to work with other IC Directors to achieve comprehensive registration of NIH-funded trials in ClinicalTrials.gov
II. NIH Public Access Policy: Update
Dr. Hays presented a time-line summarizing both the pre-release and post-release milestones of the policy, including the March 1, 2005, Report to Congress. He noted that the Public Access Policy Working Group made two key recommendations, among others, at its July 11 meeting:
He then reviewed a detailed time-line of the ongoing outreach activities to both NIH staff and the public, noting that —
Next steps include continued outreach to stakeholders and investigators; evaluation of the policy in reaching its objectives and of the effectiveness of NIH outreach; batch uploading by IRPs, libraries, repositories, and publishers; and continued communication with NIH staff.
Dr. Zerhouni thanked Dr. Hays and the WG for all of the hard work toward creating this new venue. He asked that they continue to find ways to ensure that NIH intramural scientists clearly understand the policy and that they possibly create a compendium of what professional organizations are saying about the policy to share with the intramural scientists. He also asked that the group be kept posted on progress and concerns.
III. Minority Research Training Programs Update
Dr. Ruffin discussed the recently published National Research Council report, Assessment of NIH Minority Research Training Programs: Phase 3, prepared under the auspices of the Committee for the Assessment of NIH Minority Research Training Programs, co-chaired by Drs. John Bailar III and Willie Pearson Jr. (see http://books.nap.edu/catalog/11329.html). In 2001, NCMHD contracted with NAS to undertake an independent phase three assessment. The study charge asked that the study address the following questions:
The Committee was also charged with developing policy recommendations for an improved coordinated tracking system.
Dr. Ruffin then introduced Peter Henderson, who served as an Acting Study Director through two different periods during 2004. Mr. Henderson summarized the Committee’s findings and recommendations for the group — the recommendations are located at http://www.nap.edu/books/0309095751/html/159.html et seq.
The group discussed the issues and recommendations, and Dr. Berg mentioned that a working group of the National Advisory General Medical Council (NAGMC) has been discussing similar issues. Dr. Zerhouni asked that Dr. Ruffin work with Dr. Berg to use this NAGMC working group as a base for addressing the NAS recommendations.
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