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FDA
Current January 2006
Developing safe and effective cancer drugs is a process that should include an understanding of clinical, legal, and regulatory matters. Often, cancer patient advocates (cancer patients and their families) want a more active role in the development and regulation of cancer drugs.
The Food and Drug Administration (FDA) initiated the Cancer Drug Development Program to incorporate the perspective of patient advocates into the drug development process. This program provides cancer patient advocates an opportunity to participate in the FDA drug review regulatory process. The Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Office of Special Health Issues (OSHI) in the Office of the Commissioner (OC) are participating in this program.
The program's first recruits were announced in May of 2001. The FDA selected 25 cancer advocates representing 15 cancers to participate in the Program. The patient consultants were selected from a pool of 109 applicants representing 20 cancers. The patient consultants have participated in a two-day workshop and continue learning about FDA in monthly telephone lectures. The patient consultants have participated in over 50 sponsor/FDA meetings providing the patient perspective on topics such as clinical trial design, endpoint determination, expanded access protocol development, and clinical trial patient recruitment strategies.
Currently 37 patient consultants are enrolled in the program. The program now recruits patient consultants on an as needed basis. A Patient Consultant's term is not time-limited.
The cancer patient advocates chosen to serve, as patient consultants, are selected
to participate in meetings by matching a specific cancer and the proposed indication
for the new cancer drug being developed. The patient consultant participates
in meetings (via telephone ) between the FDA and drug companies. As with the
previous recruits, a newly selected patient consultant receives approximately
two days training from FDA staff (at FDA's Rockville location ) and participates
in the monthly telephone lecture series in preparation for these meetings.
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1Participation by telephone is consistent with the participation
of other outside scientific/clinical consultants to FDA during the drug development
phase.
2Each patient consultant will be traveled to FDA offices in
Rockville, MD for two days of training. All expenses will be paid by FDA.
The FDA staff provides background training and support to the patient consultant. The initial training for the program takes place at FDA offices in Rockville. FDA pays travel expenses, per diem and a daily salary.
The training will consist of:
In order to provide consultation to both FDA and the drug company, it is important that the patient consultant have background information on the drug under review. Approximately three weeks before each meeting, the patient consultant is mailed the meeting package containing the meeting issues and questions. The patient consultant reviews the meeting package in preparation for the meeting. After reviewing the meeting package, the patient consultant's questions can be answered in the pre-meeting (via telephone) with FDA staff before the FDA and drug company meeting.
All aspects of this meeting, including the meeting itself, the meeting package, and even the existence of the application with FDA are confidential.
JoAnn Minor
Office of Special Health Issues
Cancer Liaison Program
301-827-4460