An Assessment of Health‐related Quality of Life Endpoints Reporting in Trials Supported by the National Cancer Institute

A study examined how publications are reporting health‐related quality of life (HRQOL) in clinical trials supported by the National Cancer Institute (NCI).

“The importance of capturing and reporting health‐related quality of life (HRQOL) in clinical trials has been increasingly recognized in the oncology field. As a result, the National Cancer Institute (NCI) began to provide support for correlative HRQOL studies in cancer treatment trials. The current study was conducted to assess the publication rate of HRQOL correlative studies in NCI‐supported treatment trials and to identify potential factors positively or negatively associated with publication rates,” the study authors wrote.

This was a retrospective review of NCI databases in order to locate cancer treatment trials that received funding from the NCI to assess HRQOL and determine the prevalence of HRQOL studies that have been completed and published in a peer-reviewed journal.

Final analysis included 108 trials, of which 58 (54%) had a parent trial publication. Of those with a parent trial publication, 36 (62%) had a published HRQOL result (independent publication, n=20; included and/or reported in the parent trial publication, n=16). An association was observed between the publication rates and the length of time between trial activation and closure as well as cancer type.

The study was published online in the journal Cancer.

“The results of the current study demonstrated that approximately 45% of the PT publications were followed by a HRQOL publication within 1 year, to allow the knowledge to be used in patient treatment decision making. The authors believe the current analysis is an important first step toward a better understand of the challenges that researchers face when reporting HRQOL endpoints,” summarized the study authors.