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Freedom of Information Act Office

IC Directors' Meeting Highlights

April 12, 2002

To: IC Directors
From: Director, Executive Secretariat
Subject: IC Directors Meeting Highlights—April 4, 2002

I. Research Coordination Council (RCC)

Dr. Skirboll reviewed the first RCC meeting on March 15, which included representatives from all HHS agencies. She also distributed copies of the slide presentation given at that meeting and draft RCC Research Themes and Priority Research Areas. The RCC was established by the Secretary based on the Budget Council's recommendation. The group will meet quarterly to enhance coordination of research activities across the Department in relation to the FY04 President's budget. According to the Department, such coordination does not include investigator-initiated biomedical research. Dr. Spiegel believes the focus is on avoiding duplication of research among HHS agencies not among investigators, but this is not clear.

The draft themes were discussed at the first meeting of the RCC, and four workgroups were established, based on the four ASPE offices: Human Services Research; Disability, Aging, and Long Term Care Research; Health Research; and Applied Science Research. Mr. Bobby Jindal, ASPE, will oversee the RCC, and an ASPE Deputy Assistant Secretary will lead each workgroup. The themes are being finalized and will be incorporated into the FY04 budget call, which will be sent to the OPDIVs by the end of the month. After the agencies submit their budget proposals, the RCC will reconvene to look for areas of coordination. Dr. Kington added that he is unclear about how the RCC relates to the HHS Data Council, on which he represents NIH.

II. Adverse Events Reporting

Dr. Skirboll noted that Dr. Koski chairs the NSTC Human Subjects Research Subcommittee, which meets approximately twice a month. That group has taken up the issue of "harmonizing" Federal adverse events (AE) reporting requirements. Dr. Koski has asked NIH and FDA to cochair an effort to assess the collection and analysis of safety information in clinical research across the Federal government.

Dr. Patterson said that, before responding to Dr. Koski's request, Dr. Kirschstein first wished to carry out an internal assessment of NIH's AE reporting process(es). Dr. Kirschstein established an NIH working group on adverse event reporting, which Drs. Patterson and Wittes co-chaired. The group asked three fundamental questions: What safety information do ICs collect and in what time frame? How is it analyzed? How do ICs apply the information to inform the design and conduct of ongoing and future research?

To explore these questions, the group developed a pilot survey that was ultimately completed by nine divisions within NCI, NIAID, and NEI. Based on the findings from the survey, the group developed five recommendations with the goal of identifying practical means to enhance our oversight of clinical research. NIH should:

adopt a standard AE definition and reporting timelines.

develop a "straw man" set of core data elements for AE reports and add IC-specific elements as necessary. These should be tested both intramurally and extramurally.

consider developing a core reporting format for NIH.

explore the development of uniform criteria for describing clinical toxicities (e.g., WHO and NCI CTC). Severity thresholds may need to vary according to the clinical context.

assess the feasibility of creating and sharing comparable data sets by examining the current IC data systems.
The next steps are to develop an NIH approach to harmonizing adverse events reporting and then to determine what NIH findings and plans should be conveyed to Dr. Koski.

Dr. Gallin noted that this effort is central to patient safety. He said that harmonization with the goal of making it easy for investigators to complete these reports is critical, as is a common definition of AE. He suggested that the ICs examine NCI's definitions for toxicities, then edit or add to that list. He recommends quarterly AE reports for every protocol in the CC. He added that a simple hand-held computer-based reporting system would be an extremely useful tool.

Dr. Straus noted that while NIH can harmonize internally, the requirements of DSMBs, drug companies, sponsors, and others will continue to be idiosyncratic. We need to make sure that we don't create an additional burden for NIH investigators. He also noted that many ICs have created their own computer systems that don't communicate with each other. Dr. Patterson added that in the gene therapy realm, NIH and FDA accept a common reporting format and have developed a database for reporting and analyzing clinical trial safety information that is compatible with some existing NIH computer systems, such as the NCI ADEERS. Dr. Nakamura asked about expanding the system beyond biologics. Dr. Skirboll said that the data base Dr. Patterson developed with CBER (the Genetic Modification Clinical Research Information System) could be demonstrated to the group, although there are no current plans to expand it beyond gene therapy.

Dr. Gottesman agreed that there is a critical need to standardize AE reporting requirements in the intramural program. He raised two additional issues: how to distinguish between expected and unexpected events, and how to discern the relevance of the event to the protocol. In terms of the first issue, the CFR defines expectedness in relationship to what an investigator would expect based on the pre-trial research. Dr. Gottesman said he would prefer to err on the side of reporting anything questionable and to let the IRB decide on its significance. Dr. Kirschstein asked the Executive Secretariat to distribute Dr. Patterson's slides and termed this the beginning of an important set of discussions. She said IC Directors need to discuss the issue further after they have read and commented on Dr. Patterson's slides. Dr. Nakamura said that at-risk populations need to be taken into account in this process. Dr. von Eschenbach noted that this is an important opportunity for NIH to contribute to a larger solution and to play a leadership role.

III. Information Items

Dr. Kirschstein announced that Mr. Benowitz is leaving his position as Director, OHRM, to become Director of the new Office of Strategic Management Planning, effective April 19. Mr. Fred Walker will serve as Acting Director, OHRM.

Mr. Donald Poppke will serve as Acting Director, Office of Budget, upon Ms. Quantius' departure on April 16.

Dr. Kirschstein mentioned that Drs. Maddox and Fauci are traveling with the Secretary in Africa this week.

Dr. Zerhouni's first meeting with Dr. Kirschstein is scheduled for tomorrow.

Yesterday Dr. Kirschstein was a guest on C-Span's "Washington Journal" program, during which she took calls from all over the country.

Dr. Kirschstein introduced Dr. Judith Salerno, Deputy Director, NIA, to the group.

Dr. Nakamura said that the Good Morning America program is airing a series attacking basic research in NIMH and NSF. So far NIMH has not received any inquiries about the series. In the past this sort of media program has prompted congressional hearings, so NIMH will be prepared for that possibility.

Dr. Kington mentioned that next week NIAAA is issuing a call to action to curb college drinking. NIAAA estimates that some 1,400 college students die in drinking-related events each year. Dr. Katz called this call to action a wonderful example of how we can disseminate research results.

Dr. Ehrenfeld noted that CSR recently had two additional study section boundary team meetings for the new digestive sciences and immunological sciences IRGs. There has been a good response by the outside research community, and the process of reorganizing CSR's study sections is going well.

Dr. Spiegel said that the April 4 issue of the New England Journal of Medicine is running an article on adult-to-adult living donor liver transplants. Congressman Dan Miller (R-FL), a member of our House Appropriations subcommittee, has a personal interest in this issue. NIDDK sponsored a meeting on this topic in December 2000 and is funding an initiative in FY02 to create a registry to monitor donor outcomes, but NIH's interest is not regulatory.

Ms. Houser reported that Mr. Scott Whitaker, ASL, and Mr. Paul Powell, Deputy Assistant Secretary for Congressional Liaison, visited NIH on Tuesday. Mr. Whitaker is in charge of preparing for Dr. Zerhouni's confirmation hearing, which he said is scheduled to be on a fast track. No one expects the hearing to be a problem, but Senator Brownback is expected to raise issues of cloning when the nomination is taken up on the floor of the Senate. Mr. Whitaker asked about whether it takes NIH longer to respond to Congress under the new OS rules. He also asked us to give him a proposal about what things might be appropriate for him to clear and what things might just be sent to him for information; currently everything must be sent to him for clearance.

Karen Pelham O'Steen
cc: OD Staff

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