ROCKVILLE, Md—The Food and Drug Administration (FDA) is expanding the role of patient advocates in the approval process of cancer drugs. For some years, patient representatives have participated in meetings of the Oncologic Drugs Advisory Committee (ODAC). FDA’s new corps of patient consultants will initially participate in discussions of the design of phase III clinical trial protocols, as well as ODAC proceedings.
Psychologist JoAnn Minor, director of FDA’s Patient Consultant Program, explains the new role for patient advocates and the reasoning behind it in this interview with Patrick Young, Oncology News Inernational’s Washington Bureau Chief.
Oncology News International: What do you expect the patient consultants to contribute to the drug development process?
Ms. Minor: Patient consultants will provide the patient perspective—a voice at the table focused on patient issues. In this new program, FDA is asking the patient consultant to be a part of the process as we work with drug companies to develop protocols for phase III trials.
Our focus is going to be on involving patient consultants in the end-of-phase-II meetings when FDA sits down with a company to discuss their phase III clinical trial protocol.
Patient consultants can help with questions that particularly need the patient perspective such as: How can we best recruit patients for the trial? Is the toxicity such that patients will be able to manage and tolerate it? Should the company consider an expanded access program? FDA is trying to provide a way for advocates to understand and contribute to the drug review process early on.
ONI: I can understand using a cancer survivor as a patient consult, but you also opened the program up to parents, other family, and friends of cancer patients.
