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FDA Public Workshop: 2018 Clinical Outcome Assessments in Cancer Clinical Trials

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The 2018 COA-CCT workshop is a full-day scientific event developed by the Oncology Center of Excellence Patient Focused Drug Development program in collaboration with FDA clinical, statistical, and psychometric experts, and cosponsored by the American Society of Clinical Oncology (ASCO). The workshop will include international regulatory, payer, academic, patient, industry, and policy leaders. In the first half of the day, we will explore PRO assessment in cancer trials: What should we measure? How can we measure it? A proposed core PRO strategy focusing on symptomatic adverse events, an overall side effect summary measure, disease symptoms, and well-defined functional impacts will be discussed. The second half of the day will be dedicated to analysis and presentation methods. Panelists will discuss efforts to standardize how PRO data are analyzed and interpreted. The final session will provide a look at how FDA clinical and statistical reviewers are currently analyzing submitted PRO data and begin a dialogue on moving toward standard analysis and presentation methods to better inform safety, efficacy, and tolerability.

Date: June 22, 2018

Time: 8:15 am to 5:00 pm


FDA White Oak Campus, Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993

FDA Campus Information, (e.g., local airports, directions, and local hotels)

Workshop Registration disclaimer icon

Webcast Information

Meeting Information

• Draft Agenda


Janice Kim, 301-796-9628,; Valerie Vashio, 301-796-3710,; or Caroline Schenkel, for more information.

Page Last Updated: 06/08/2018
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