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  1. News & Events for Human Drugs

Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials

Goals and Objectives:

  • Collaborate with C-Path's Patient-Reported Outcome (PRO) Consortium. Take advantage of the timing of this event (the Consortium’s annual workshop will be held the following day, in the same venue) to interface with key stakeholders and attendees at the PRO Consortium’s annual workshop.
  • Engage with leaders in academia, industry, international regulatory and HTA bodies as well as patient groups on COAs in cancer clinical trials.
  • Leverage expertise from multiple experts in the PRO measurement development community.
  • Propose and gain stakeholder feedback on a modular approach to PRO measures in cancer clinical trials.
  • Conduct panel sessions on PRO-based assessment of physical function.
  • Identify existing methods to measure physical function in cancer clinical trials and seek optimal instruments and analyses for trials moving forward.
  • Identify ways to standardize and optimize collection and analyses of PRO assessments in cancer clinical trials.
Who Should Attend:  This public workshop is intended for stakeholders interested in advancing COAs in cancer drug development including, but not limited to, academia, industry, regulatory agencies, consulting firms, HTA groups and patient groups.


 Date:  April 26, 2016

 Location:  Sheraton Silver Spring Hotel, Silver Spring, MD 

Registration:  http://www.cvent.com/events/workshop-on-clinical-outcome-assessments-coas-in-cancer-clinical-trials/event-summary-13aacca1fdc14ca188666e28f7c4d287.aspx?i=f462d3bd-439d-43d1-8325-8ebb77ccb863

Contacts: Dianne Spillman, Dianne.spillman@fda.hhs.gov



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