September 21, 2000
Members of Disease Prevention and Management Strategic Planning Committee (DPMSPC) Planning Group Roster
Drs. Schrier (Discussion Leader), Rossini, Sandler, White, Jacobsen, Detre, Combes, Polonsky, Potts, and Powe
Members not present:
Drs. Whelton and Friedewald
NIDDK Advisory Council Members:
Drs. Wing, Weaver-Osterhold, Puczynski, Porte and Ms. Haughton
The major areas to be addressed at this meeting included a review of the major ongoing clinical trials and epidemiological studies supported by the Institute, private sector support for these studies, the need for a central repository for biological specimens (and data) derived from both clinical trials and cohort studies, and identification of possible gaps in our portfolio of clinical trials and epidemiological studies (see agenda attached for detailed questions pertaining to each of these issues). At the time of the meeting Dr. Schrier, Discussion Leader of the DPMSPC, added another topic for discussion, the recruitment of participants for clinical trials and epidemiological studies.
Major Discussion Point #1:
The prioritization/implementation of ideas for major projects
It was suggested that there be a process to filter through multiple inputs for ideas about major clinical trials and epidemiological studies in order to choose the best ideas for implementation. Many of the clinical trials implemented by the Institute are major investments of resources. Some of them may be congressionally mandated. The route for investigator-initiated clinical trials through the Institute, including the review process, was discussed. It was suggested that the process for review of clinical trials at the Veterans Administration, which are all investigator-initiated, may serve as a model for Institute. One Division noted that they use of small grants (R03) to plan clinical trials.
Major Discussion Point #2:
Models for collaborative research between the NIH and the private sector
What are the best models for conducting collaborative clinical research in general and between the NIH and the private sector, including clinical trials? The Immune Tolerance Network, a project jointly funded by the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Foundation, was put forward as a collaborative has been successful. It was suggested that the NIH Foundation be utilized to coordinate support from the pharmaceutical industry and other private sources for clinical trials and epidemiological studies. Barriers to pharmaceutical industry support for clinical trials include head-to-head comparisons of drugs from different companies. Currently, no guidelines exist within the Institute or across the NIH regarding the collaboration with the private sector. However, a variety of formal relationships are in place between the NIDDK and the private sector for clinical trials ranging from CRADAs to conditional gifts. Issues of intellectual property ownership need to be dealt with in any relationship with the private sector. Along the same lines, no uniform system exists for reimbursement from insurance companies for costs associated with participation in a clinical trial. It was pointed out that the private sector should be better informed of the potential opportunities for collaboration with the NIH.
Major Discussion Point #3:
Recruitment of participants to clinical studies
It was noted that there are continuing challenges in general to recruit for clinical trials and in particular to recruit minority participants. Educational tools geared towards both physicians and patients are needed to clearly describe the benefits of participating in clinical trials. What are the essential sources, for example community leadership that must be tapped for recruitment to be improved? How can the generalization of clinical trials be enhanced?
Major Discussion Point #4:
Central repository for patient specimens and data
Examples of the repository requirements of various clinical trials supported by the Institute were presented. It was evident that a large number of patient samples have been collected and in some cases specimens from the same clinical trial are being stored at different sites. Information from the National Bioethics Advisory Committee was reviewed. Ethical (including obtaining appropriate informed consent) issues to keep samples "forever" need to be considered. A suggestion was made to obtain samples from persons who do not have frank disease but are at high risk for occurrence of disease.
Major Discussion Point #5:
Deficit in current portfolio of clinical trials and epidemiological studies
While no major gaps in our research portfolio for clinical trials and epidemiological studies were identified, cooperation among Institutes was emphasized. Piggy-backing on existing studies was also emphasized as a cost-effective way to obtain additional information. A variety of existing reports or planned meetings to identify research opportunities were described (e.g., Diabetes Working Group Report, Progress Review Group on the Bladder).
Dr. Schrier then assigned meeting participants to various working groups as listed below.
Clinical Trials Planning Process
Dr. Porte (Group Leader)
Clinical Trials Private Sector Support
Dr. Potts (Group Leader)
Dr. Kusek (Group Leader)
Biological Specimen Repository
Dr. Everhart (Group Leader)
Dr. Schrier asked that each working group meet for about an hour. He also requested that each group prepare a report to be presented to the Director, NIDDK, with the following timetable.
November 15, 2000: First draft of report from each working group for circulation to the entire DPMSPC.
January 1, 2001: Report to Director, NIDDK
February 7-8, 2001: Presentation of reports to the NDDK Advisory Council