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U.S. Department of Health and Human Services

For Consumers

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Drug Development Patient Consultant Program



Developing safe and effective drugs is a process that should include an understanding of clinical, legal, and regulatory matters. Often, patient advocates want a more active role in the development and regulation of drugs for serious and life-threatening illnesses.

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 patient advocates representing serious and life-threatening illnesses 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 program has been expanded to include other serious and life-threatening illnesses.  Patient consultants in the program 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.

The program now recruits patient consultants on an as needed basis. A Patient Consultant's term is not time-limited.


The patient advocates chosen to serve, as patient consultants, are selected to participate in meetings by matching a specific illness and the proposed indication for the new therapeutic 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.

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.

  1. Personal experience with a serious or life-threatening illness, either as a patient or as a family member or friend of a  patient.
  2. Experience in patient advocacy.
  3. Ability to represent the interests of patients and communicate their perspective.
  4. General knowledge about drug development research and the clinical trial process.

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:

  1. A one and one-half day workshop, at FDA an facility in Rockville, MD, that provides an overview of FDA, the drug review process, and the patient consultant’s obligations under the conflict of interest and confidentiality regulations.
  2. A site visit to an FDA scientific review division hosted by OSHI.
  3. A monthly telephone lecture series building on the workshop.
  4. A patient consultant from the current team of trained patient consultants assigned to each newly recruited patient consultant as a mentor. The mentor is available for ongoing support and one on-one-training.

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 product application with FDA are confidential.


Office of Special Health Issues