Insufficiencies Discovered in Patient-Reported Outcomes Data From Genitourinary Cancer Clinical Trials

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Investigators may have found a significant unmet need for improved analyses and reporting of patient-reported outcomes in genitourinary cancer clinical trials, according to a recent study published by Paravathaneni et al in eClinicalMedicine.


Genitourinary cancers affect over 444,000 patients each year in the United States and are among the most common malignant diseases in male patients. Chemotherapy has traditionally been the standard treatment option in patients with genitourinary cancers; however, within the past 15 years, many new targeted treatment options have been approved to enhance outcomes such as overall survival and response rates. Patient-reported outcomes are often analyzed in cancer clinical trials, but the quality of these analyses in genitourinary clinical trials is currently unknown.

How cancer and its therapy impact a patient’s life may be critical factors to consider when selecting treatments. Although many new therapies may improve survival, if the side effects too greatly impact a patient’s quality of life, that drug may not be an optimal choice.

Patient-reported outcomes that take into account the disease, the treatment received, and other personal factors are considered significant indicators of how cancer drugs may impact a patient’s health status and quality of life. By assessing the benefits and risks of these drugs using patients’ perspectives, researchers and physicians may be able to improve the development of patient-centered care. These measures can often include questions regarding the side effects of treatment to financial concerns and access to caregiver support. 

Study Methods and Results

In the recent study, the investigators conducted a systematic review of the quality of patient-reported outcomes data collected in clinical trials that led to the approval of novel therapies for genitourinary cancers between February 2007 and July 2022. The investigators identified 40 clinical trials that met inclusion criteria. They then analyzed the clinical trial protocols and compared the trials’ intentions with the patient-reported outcomes data that were presented and published. They further analyzed the quality of the patient-reported outcomes data based on a scoring scheme they developed.

The investigators discovered that only 67.5% of the trial publications reported patient-reported outcomes data—including 10% that reported preliminary patient-reported outcomes data in the primary clinical trial publication and 57.5% that reported the data in a secondary publication. Among all 40 of the clinical trials, 31 of them were designed to collect patient-reported outcomes data, whereas nine of them were not. The median time between the primary clinical trial publication and the publication of the patient-reported outcomes was 10.5 months.

The investigators emphasized that the types of patient-reported outcomes data that were collected as well as the statistical analyses used to examine the data varied greatly among the studies. Additionally, many of the trials still needed to perform a quality analysis. The mean quality score of the patient-reported outcomes data was 11.10, ranging from 6 to 24 out of a possible total of 24 points.


The investigators underscored that their new findings revealed that patient-reported outcomes data of the highest quality may not often be collected in a timely manner. They hope their research will improve clinical trial designs and approaches to collecting and analyzing patient-reported outcomes data in order to improve patient outcomes and quality of life.

“Our data showed a considerable gap in reporting patient-reported outcomes and in the quality of design and conduct of patient-reported outcomes–related trial endpoints. With the expanding array of therapies for genitourinary malignancies, the accessibility and clear presentation of patient-reported outcomes data are also essential for tailoring personalized treatment plans for patients, highlighting the crucial need for improved reporting and accessibility of this information,” concluded senior study author Jad Chahoud, MD, MPH, Assistant Member of the Department of Genitourinary Oncology at the Moffitt Cancer Center.

Disclosure: The research in this study was supported by the National Cancer Institute and the R.S. Evans Foundation. For full disclosures of the study authors, visit

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.