<
 
 
 
 
×
>
hide
You are viewing a Web site, archived on 08:56:19 Nov 19, 2004. It is now a Federal record managed by the National Archives and Records Administration.
External links, forms, and search boxes may not function within this collection.

FDA Advisory Committees

THE NOMINATION GUIDE

FOR THE SELECTION OF

PATIENT REPRESENTATIVES

FOR

ADVISORY COMMITTEES

REVIEWING CANCER DRUGS, BIOLOGICS, OR DEVICES

 

THE SUBMISSION

Nominees should submit a resume that focuses on the criteria listed below and explains their experience with cancer, for example, cancer advocacy, cancer work, or education. A sample resume format is attached. The resume must follow this format. A nominee need not qualify under all criteria. If a nominee does not have experience under one criteria, but is highly qualified under other criteria, he/she may be selected as a patient representative.

THE CRITERIA

1. Personal experience with cancer, as a cancer patient or as a supporter of a cancer patient (for example, spouse, partner, parent, sibling, grandparent, or care giver);

2. Experience in cancer advocacy;

3. Ability to represent the interests of cancer patients;

4. Ability to communicate the perspective of cancer patients;

5. Ability to identify issues that are important to cancer patients;

6. Sufficient knowlege about cancer research studies, and/or personal experience as a participant in cancer research studies, to enable the nominee to participate effectively in advisory committee discussions of cancer research studies; and,

7. Ability to disseminate information about their experience as an advisory committee member to the cancer community

THE SOLICITING OF NOMINATIONS

The agency will solicit nominations by:

1. Direct mailing of announcement of solicitation to patient advocacy groups, community organizations, other public interest organizations, and individual cancer advocates;

2. Internet announcement on Office of Special Health Issues (OSHI) home page at http://www.fda.gov/oashi/cancer/cancer.html.

3. Display of announcement of solicitation at conferences, advisory committee meetings, workshops, etc., that FDA staff members attend, and at other conferences, meetings and workshops.

Nominations may be submitted by individuals, patient advocacy groups and other organizations. Self-nomination is also acceptable. Nominations should be submitted to the Cancer Liaison Program, Office of Special Health Issues (HF-12), Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857.

THE CANDIDATE DATABASE

This database will contain the resumes of each person designated as a qualified patient representative. Nominations will be solicited for new patient representatives each year in accordance with the aforementioned solicitation process. In addition, the data base will be updated once every two years through a mailing to each person in the pool of patient representatives, asking if he/she wishes to continue to be considered for future advisory committee meetings. If a return reply is received by the specified date, the patient representative will be maintained in the database for two more years.

THE REVIEW/SELECTION PANEL

Three representatives of the Cancer Liaison Staff in the Office of Special Health Issues (OSHI) will review the nominations, and eligible patient representatives will be entered into the patient representative database. Nominees will be notified by mail if it is determined they are eligible. A review and selection panel will be established. The panel will consist of one representative from the OSHI, one representative from each FDA review division that reviews oncology drugs, biologics, or devices, and one representative of the FDA's Advisors and Consultants staff. This panel will select one patient from the patient representative database, to represent the following cancers: breast cancer, prostate cancer, lung cancer, and colon/rectal cancer. [These cancers were cited by the American Cancer Society in the "Cancer Facts & Figures-1997" as the "Leading Sites of New Cancer Cases and Deaths---1997 Estimates."] Each patient representative will be selected to serve a term of two years and will be invited to participate in FDA advisory committees that are reviewing cancer therapies specific to their cancer experience. When an FDA advisory committee is reviewing a cancer therapy for a cancer other than those previously listed, the panel will meet and select a patient representative with experience in that specific cancer. Once selected that patient represent will serve a term of two years. If the patient representative database does not have a candidate with specific cancer experience, FDA will contact cancer advocacy groups for nominations.

 

Attachment

 

Prepared by: Cancer Liaison Program, Office of Special Health Issues

Last revised March 5, 1998

[OSHI HOME]