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FDA to Include Advocates in Planning of Phase III Trials

FDA to Include Advocates in Planning of Phase III Trials

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.

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