Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials

FDA’s CDER and C-Path’s PRO consortium second workshop

Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium, in collaboration with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), was conducting a public meeting titled Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials in April. The purpose of the workshop was to provide a forum for collaborative multidisciplinary discussion to identify opportunities and address challenges for clinical outcome assessments (COAs), particularly patient-reported outcome assessments, in oncology drug development.

During this year’s workshop, a broad array of international stakeholders involved in oncology drug development and patient-reported outcome measurement provided perspectives on the role of patient-reported symptomatic adverse events in evaluating and describing the tolerability and safety of anti-cancer agents. Speakers and panelists explored the utility of information derived from existing and emerging patient-reported measures and discussed potential ways to improve the collection, analysis, and presentation of the data to support drug development and better inform treatment decisions. In addition, discussion of possible ways to assess an investigational drug’s overall side effect burden as a clinical trial endpoint was initiated. This workshop included panelists and speakers from regulatory agencies, academia, patient advocacy groups, and the medical product industry.

For the slides from the workshop, please follow the below link:

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