Freedom of Information Act Office
IC Directors' Meeting Highlights
October 21, 2002
|From:||Senior Policy Analyst, Executive Secretariat|
|Subject:||IC Directors' Meeting Highlights September 26, 2002|
Dr. Zerhouni opened the meeting by introducing Dr. Roderic Pettigrew, attending his first meeting as Director of NIBIB, and led the group in a round of applause for him. Dr. Pettigrew said he looks forward to meeting those IC Directors he has not already met personally and emphasized that he welcomes advice from all in the group.
I. Adverse Events Reporting System
Dr. Skirboll noted the need for effective collection of data on adverse events in clinical studies and increased urgency in recent years for development of a collection system and improved coordination between the NIH and FDA. She introduced Dr. Amy Patterson, Director of the Office of Biotechnology Activities, OSP, who has led NIH's development of a national database for gene transfer clinical research, which includes a reporting format accepted by both the NIH and FDA.
Dr. Patterson emphasized that her presentation was informational and that she still welcomes any suggestions from IC Directors regarding the system. She said that the goals driving development of the system were to enable systematic analysis of data across all clinical studies and to enhance communication and application of knowledge gained from the studies. The result is called the Genetic Modification Clinical Research Information System, or GeMCRIS. The system does not dictate time frames or requirements for reporting of adverse events; it just provides a standardized means for reporting, organizing, and analyzing data.
Dr. Patterson discussed features of the system, including how investigators will use it to report on their studies, data that it will capture, and reports that it can generate. It will serve diverse user groups, from Federal Agencies and National Advisory Committees; through local review bodies, investigators, and research sponsors; to policymakers, patients, and the public. In response to questions, Dr. Patterson clarified that only a portion of the data reported and not raw data will be available to the public, and that no analytical tools are built into the system now (phase 1 of development) but that phase 2 development will include additional analytical tools.
Dr. Zerhouni asked about industry response, and Dr. Patterson said it had been mixed. She said industry representatives are pleased at the harmonization between the NIH and FDA. Dr. Skirboll added that industry has been and remains concerned about reporting adverse events because they consider adverse event data to be proprietary, confidential information industry concern does not focus on this database.
II. Update on Hormone Therapy Scientific Workshop
Dr. Kirschstein distributed the latest draft of the workshop agenda and said it is close to final. The planning group has worked with pharmaceutical industry representatives and has now included in the program a presentation of the industry perspective. The workshop will be an open meeting, but attendees must register and those who wish to comment in the time provided must submit a written statement in advance. Mr. Burklow is preparing talking points and a press package that will be available before the workshop begins. Discussion among the group reached a consensus for holding a press event at the end of the workshop so that the participating agencies can also present a consistent, coherent message on the outcome of the workshop.
Dr. Zerhouni thanked Dr. Kirschstein and all the planning team for their work in moving preparations for the workshop ahead so effectively.
III. Information Items
Dr. Ehrenfeld reminded the group that the NIH's Combined Federal Campaign kick-off event is today, beginning at 11:30, outside the Natcher Building. She appreciates participation by IC Directors and she thinks their personal support for their ICs' CFC keyworkers is crucial. She is working toward achieving the campaign goals as quickly as possible, believing a shorter campaign is preferable.
Dr. Baldwin said that her staff is reviewing materials from the meeting on conflict of interest held on Monday and is starting to discuss institutional conflict of interest. She appreciated the participation in the meeting, either directly or through a representative, of the IC Directors.
Dr. Gallin announced that the NIH Foundation has finished its fundraising for the NIH Family Lodge. Groundbreaking will take place on October 29.
Dr. Zerhouni told the group that yesterday's stem cell hearing went well. A number of witnesses and Senators said independently that the NIH is doing a good job in its role of supporting stem cell research that is permitted under the current policy.
Dr. Zerhouni announced that Dr. Kirschstein and he have agreed that he will appoint a new NIH Deputy Director and she will become his Senior Advisor. He thanked Dr. Kirschstein for her help for him, personally, and for her many contributions to the NIH, and he led the group in a round of applause. Dr. Kirschstein will continue as Deputy Director until a new Deputy is appointed, and she will continue to work on hormone therapy and other issues in her new role. Dr. Katz will head an advisory group that will recommend candidates for the position, and Dr. Zerhouni encourages IC Directors to send Dr. Katz any suggestions they might have.
cc: OD Staff