Researchers of a recent study highlighted a significant gap in the analysis and reporting of patient-reported outcomes (PROs) in genitourinary cancer clinical trials. Investigators systematically reviewed clinical trials that led to the approval of novel therapies for genitourinary cancers between February 2007 and July 2022. Of the 40 clinical trials that met the inclusion criteria, only 67.5% reported PRO data, with a considerable delay between the primary clinical trial publication and the publication of the PROs. Furthermore, the study found inconsistencies in the types of PRO data collected and the statistical analyses used. Many trials lacked a thorough quality analysis of PRO data, with the mean quality score being relatively low.
These findings underscore the need for improved collection and timely reporting of high-quality PRO data in clinical trials. The researchers also emphasized the importance of this data in developing personalized treatment plans for patients and called for enhanced reporting and accessibility of PRO information in the context of an increasing array of therapies for genitourinary malignancies.
Reference: The ASCO Post Staff. Insufficiencies Discovered in Patient-Reported Outcomes Data From Genitourinary Cancer Clinical Trials. The ASCO Post. Updated February 7, 2024. Accessed March 5, 2024. https://ascopost.com/news/february-2024/insufficiencies-discovered-in-patient-reported-outcomes-data-from-genitourinary-cancer-clinical-trials/
