Public Release: 

4/26 Workshop on COAs in Cancer Clinical Trials

Co-sponsored by FDA and C-Path's Patient-Reported Outcome Consortium

The Critical Path Institute (C-Path)

The Food and Drug Administration's (FDA) Office of Hematology and Oncology Products, in co-sponsorship with the Critical Path Institute's (C-Path) Patient-Reported Outcome (PRO) Consortium, is holding a public meeting titled "Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials" on Tuesday, April 26, 7:30am-5pm. The purpose of the workshop is to provide a forum for collaborative multidisciplinary discussion to identify best practices for the use of PRO measures in oncology drug development. During this workshop, a broad array of international stakeholders involved in oncology drug development, regulation, utilization, and reimbursement will provide perspectives on the current approaches to PRO assessment in oncology trials, explore the utility of information derived from existing PRO measures, and identify potential ways to improve alignment and strategic use of PRO measures to support oncology drug development and better inform treatment decisions. The workshop will include focused discussions on important core patient-centered concepts, including patient-reported disease-related symptoms, symptomatic adverse events,and physical function. This workshop will include panelists and speakers from FDA, international regulatory agencies and health technology assessment bodies, domestic payers, academia, pharmaceutical industry, and patient advocacy groups.

The goals of this workshop are:

·To engage with international stakeholders in cancer drug development, approval, reimbursement, and utilization to gain a better understanding of how patient-centered data is used across these different groups

·To review common PRO assessment strategies and discuss new and existing PRO measurement tools available to assess the patient experience in cancer clinical trials

· To obtain stakeholder feedback on a proposed modular PRO measurement approach in cancer clinical trials that better integrates new measurement tools and more closely adheres to U.S. regulatory requirements for product labeling

·To review available tools and approaches to the assessment and analysis of patient-reported physical function, an important component of health-related quality of life in cancer patients undergoing therapy

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