Articles Explore Lack of Patient-Reported Outcomes in Oncology Trials

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Why do patient-reported outcomes (PROs) continue to be used infrequently in oncology clinical trials when the use of PROs, in general, is a rising trend?


An April 2016 article in The RPM Report, Oncology PROs: Limited Use Due To Small Trials, Fast Drug Development, explores the potential downside to the speed and efficiency of recent oncology review processes. Referencing a study co-authored by four RTI Health Solutions researchers, the article highlights findings that only 7.5% of the drugs approved by the FDA’s Office of Hematology & Oncology Products from 2010-2014 included patient-reported outcomes. The article explores the circumstances that make including PROs in Breakthrough and Accelerated Approval drug development so challenging, and includes insights from RTI-HS Head of Patient-Reported Outcomes, Ari Gnanasakthy. View a reprint of this article here.


Carla DeMuro, MS, Head of Patient-Reported Outcomes, was interviewed in April 2016 for a Reuters article, Cancer drug labels rarely reflect patient experiences. DeMuro points out that patient reported outcomes are important because doctors and patients want to consider quality of life when making treatment decisions.

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