OBJECTIVES: FDA continues to advocate for including patient voice in drug development with the release new guidances over the last 5 years. Industry continues to invest heavily in development of new treatments for oncology. Our study aims to describe the trends in inclusion of patient reported outcomes (PROs) in industry-sponsored oncology clinical trials over the last 10 years.
METHODS: ClinicalTrials.gov was searched to identify industry-funded, oncology, interventional clinical trials initiated from 01/01/2013 through 12/31/2022. Additional outcome measure terms (e.g., patient-report OR patient report OR PRO OR diary OR quality of life OR QOL OR HRQL OR HRQOL OR health related quality of life OR questionnaire) were included to identify studies which included PROs. Study phase was also captured. Descriptive frequencies were computed overall, by year, and by study phase.
RESULTS: In the 10-year period, there were 16,718 industry-funded, interventional trials in oncology registered on ClinicalTrials.gov. Of these, 16% (n=2,755) reported including a PRO. The number of oncology trials nearly doubled over the 10-year period from 1,173 in 2013 to 2,138 in 2022. However, the proportion of oncology trials including PROs was relatively stable over the 10 years ranging from 14% (2015) to 18% (2014 and 2018). Of the 2,755 trials reporting PROs, 1,192 (43%) were phase 2 trials and 891 (32%) were phase 3 trials. The proportion of phase 2 trials including PROs ranged from 39% (2022) to 47% (2019). The proportion of phase 3 trials including PROs ranged from 28% (2019) to 35% (2014 and 2015). Results are limited to outcomes reported on ClinicalTrials.gov.
CONCLUSIONS: Despite the nearly doubling of oncology clinical trials in the last 10 years, the proportion of trials reporting use of PROs remains stable and relatively low (~ 16%). However, at least one-third of phase 3 and almost half of phase 2 trials include PROs.
