4 Topic Commentaries

FDA Veteran Shares Insights on Trial Design and Endpoints

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  Robert J. Temple, MD

  Clinical pharmacology and regulatory science

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  U.S. Food and Drug Administration (FDA)

  When carefully designed and conducted, they are the safest, fastest and most reliable method to find new effective treatments and ways to improve health.

  Source
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  Janet Woodcock, MD

  Internal medicine and regulatory science

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  U.S. Food and Drug Administration (FDA)

  They told us that some of the symptoms currently targeted by drug developers as endpoints, such as stimming, are not as important to the community.

  Source
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  Richard Pazdur, MD

  Medical oncology and regulatory science

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  U.S. Food and Drug Administration (FDA)

  Today’s draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval.

  Source
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  Paul G. Kluetz, MD

  Medical oncology; patient-reported outcomes

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  U.S. Food and Drug Administration (FDA)

  There have long been calls to provide information to patients about how they may feel and function when receiving a cancer treatment.

  Source