Trends in the Inclusion of Patient Reported Outcomes in Oncology Clinical Trials

Margaret Mordin, MS
Vice President, Market Access and Outcomes Strategy
RTI Health Solutions

Trends in the inclusion of patient reported outcomes in oncology clinical trials: analysis of (2013-2022) 
Mordin M, Castro C, Gnanasakthy A


An article published in 2015 from a review of indicated that between 2007 and 2013, there was an increase in the number of trials that use a patient reported outcome (PRO) measure, particularly in oncology trials. They reported that approximately 29% of industry sponsored oncology trials included assessment of PROs.  Over the last five years, the US FDA has advocated for including patients’ voice in drug development and has issued new guidelines on how to do so. At the same time, the health care industry has continued to invest heavily in new cancer treatment research. To better understand how PRO measures have been incorporated into research over the last 10 years, we studied industry-sponsored oncology clinical trials from 2013 through 2022. 

Out of nearly 17,000 trials identified for this period, almost 3,000 reported including PRO measures. While the number of oncology clinical trials nearly doubled during that period, we found that the proportion of those that included PRO measures remained relatively stable at about 16%. However, at least one-third of phase three and almost half of phase two trials include PRO measures.