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Cancer Liaison Program

Cancer Drug Development
Patient Consultant Program

Background and Objective

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) is initiating a new program, the Cancer Drug Development Program to incorporate the perspective of patient advocates into the drug development process. This program will provide cancer patient advocates an opportunity to participate in the FDA drug review regulatory process.

To accomplish this, the FDA will select and train cancer patient advocates for the Program. The selected cancer patient advocates will serve as patient consultants in the pre-approval, clinical trial phase of cancer drug development. The patient consultant will provide advice to the FDA and to the drug sponsor on topics such as clinical trial design, endpoint determination, expanded access protocol development, and clinical trial patient recruitment strategies.

Cancer patient advocates will be chosen by the Office of Special Health Issues (OSHI) in collaboration with the Division of Oncology Drug Products (DODP), and the Advisors and Consultants Staff in the Center for Drug Evaluation and Research. Patient consultants will be hired as Special Government Employees and, therefore, will be subject to FDA's conflict of interest and confidentiality regulations that govern each FDA employee, consultant, and advisor.

Program

The cancer patient advocates chosen to serve, as patient consultants will be selected to participate in meetings by matching a specific cancer and the proposed indication for the new cancer drug being developed. The patient consultant will participate in meetings (via telephone¹) between the FDA and drug companies. The patient consultant will receive approximately two days training from FDA staff (at FDA's Rockville location²) 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.

Criteria

1. Personal experience with cancer, either as a cancer patient or as a family member or friend of a cancer patient.
2. Experience in cancer patient advocacy.
3. Ability to represent the interests of cancer patients and communicate their perspective.
4. Sufficient knowledge about cancer research to participate effectively as a consultant in the FDA's cancer clinical trial review process.

Selection Process

Ten cancer patient advocates will be selected to serve as FDA Patient Consultants as follows:

1. A request for nominations will be sent to incorporated cancer advocacy organizations on the OSHI's Cancer Liaison mailing list. Organizations not on this mailing list, are welcome to request applications to the program.
2. The request will be posted at OSHI's web site and CDER's Oncology Tools web site.

Training

The FDA staff will provide background training and support to the patient consultant. The initial training for the program will take place at FDA offices in Rockville. FDA will pay travel expenses, per diem and a daily salary.

The training will consist of:

1. A one and one-half day workshop, at FDA in Rockville, 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 DODP's to be hosted by a Division staff member.
3. An OSHI and/or DODP staff member will be assigned to each patient consultant as a mentor. The mentor will be available for ongoing training, support and trouble shooting.

Consulting

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 will be mailed the meeting package containing the meeting issues and questions. The patient consultant will review the meeting package in preparation for the meeting. Questions the patient consultant may have, after reviewing the meeting package, can be answered in the pre-meeting (via telephone) with FDA staff before the FDA and drug company meet.

All aspects of this meeting, including the meeting itself, the meeting package, and even the existence of the application with FDA are confidential.

How To Apply

If you are nominating an individual(s) or nominating yourself, submit the applicant's resume (a sample format is attached) to:

Cancer Drug Development Patient Consultant Program
Cancer Liaison Program
Office of Special Health Issues (HF-12)
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857

The resume should focus on the criteria listed above and explain the applicant's experience with cancer, cancer advocacy, work experience, and education.

Contact

JoAnn Minor
Office of Special Health Issues
Cancer Liaison Program
301-827-4460

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