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FDA Begins Cancer Product Review Center

Richard Pazdur

Richard Pazdur (FDA.gov)

20 January 2017. The U.S. Food and Drug Administration is reorganizing its review of treatments for cancer into a structure that cuts across its traditional bureaucratic lines. FDA’s Oncology Center of Excellence is led by Richard Pazdur who served as acting director of the unit since June 2016, and also lost his wife to ovarian cancer.

The Oncology Center of Excellence aims to better coordinate evaluations of new therapeutic products for cancer by the FDA’s separate offices for drugs, biologics, and medical devices. While applications and review criteria for new treatments and devices are not expected to change, FDA says the new center plans to draw more on the expertise of scientific and regulatory professionals in these offices, where needed, and encourage more collaboration across the usual hierarchies.

In an agency blog post after his appointment in June, Pazdur noted the oncology center will emulate models from cancer care facilities and the academic world that put more emphasis on multi-disciplinary collaboration to confront the complexities of cancer. The new center also intends to encourage more patients’ perspectives in FDA’s regulatory decision making, an idea that became a personal mission after his wife Mary died from ovarian cancer in November 2015.

Pazdur says that before becoming the oncology center’s acting director, he applied some of these methods to his work as director of FDA’s Office of Hematology and Oncology Products in the agency’s Center for Drug Evaluation and Research. From 2010 to mid-2016, says Pazdur, that office approved 61 new cancer treatments, many times before their review target dates.

One of the oncology center’s tasks is to streamline the clinical trial process for testing new treatments. One approach is to shift away from standard phase 1, 2, and 3 — for early-, intermediate-, and late-stage — clinical trials, when possible. Another step to simplify clinical trials is with a common group of control subjects, usually those given a placebo rather than the test drug, for tests of multiple drugs.

In addition, simplified end-point measures of efficacy make data collection easier and can require smaller numbers of trial participants. Pazdur and colleagues outlined some of these proposals in a New England Journal of Medicine article in May 2016.

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