Trans-NIDDK Strategic Planning and Management Agenda
September 21, 2000
Building 31C, Conference Room 10
12 noon to 5 p.m.
12 Noon-12:30 p.m. Lunch and Introductions
Allen Spiegel
12:30-1 p.m. Background: Currently Supported Trials and Epidemiological Studies
5 to 10 minutes from each division that focuses on the process each has taken towards choosing and developing studies.
Background Material
Table on ongoing and planned major clinical trials and epidemiological studies including name of study, main study hypothesis, support mechanism, funding period, cost, other governmental and non-governmental support, and types of samples stored.
1-2:15 p.m Private Sector Support for Clinical Trials and Epidemiological Studies: Current Status and Opportunities to Foster Further Interaction
Discussion Leader
Robert Schrier
Discussion Questions
The institute has no standard approach to obtaining private sector support. Should there be a standard, systematic and perhaps central approach for seeking private sector support?
How should we identify opportunities for private sector support, especially through non-traditional routes such as foundations?
Should the Institute have a policy that actively encourages obtaining private sector support?
What should we be asking for besides drugs? Support of ancillary studies? Money for the main portion of the trial?
Should there be a limit of monetary support as a percent of the entire budget?
What should be the limit of private sector involvement in study design and management? Would this be different for profit and non-profit entities?
How should we handle requests from the private sector to perform trials?
2:15-3:30 p.m. Centralized Repository for Biological Samples Obtained in NIDDK-Supported Studies: Needs and Plans.
Discussion Leaders
S. Garfield and J. Everhart
Background Material
Table on size, scope, and cost of existing repositories at NIDDK and other institutes, Handbook of Human Tissue Resources from RAND, Executive Summary from National Bioethics Advisory Commission on Research Involving Human Biological Materials, and a proposal for long-term specimen storage from the Diabetes Prevention Project.
Discussion Questions
How can the Institute optimize use of study data and biological samples?
What should be the extent of responsibilities of a repository beyond a specimen bank? Should there be laboratory capability built in, particularly for processing DNA, lymphocyte transformation, or other methods of isolating genetic material?
What sorts of studies should be contributing specimens to the repository? For example, should all institute sponsored clinical trials be included, regardless of mechanism (grant, cooperative agreement, or contract)?
How do we ensure that specimens can be linked with clinical data on individual patients, yet maintain confidentiality?
What are the informed consent issues for specimen storage and testing?
3:30-4:45 p.m. Process for Identification of Gaps in NIDDK-Led Efforts
Discussion Leader
Robert Schrier
Discussion Questions
What are the major questions of public health interest within the Institute's mission that could be addressed in clinical trials and epidemiological studies?
What processes should the Institute and individual divisions follow to develop such studies?
To what extent should the Institute have a centralized process with more integrated planning for selecting and developing trials?
4:45-5 p.m. Conclusions and Future Issues
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