Effect of limited reporting in clinical trials on the ability to guide treatment decisions for real-world patients with cancer.
18 Background: National Comprehensive Cancer Network (NCCN) guidelines are derived from reviews of clinical trials. Many of these trials have strict inclusion criteria, resulting in trial samples that are not representative of the larger cancer population. We therefore sought to understand how clinical trials, referenced in the NCCN guidelines, report key patient baseline demographics relating to age, race/ethnicity, and country or geographic region. Methods: NCCN guidelines for four cancer types were reviewed: prostate, colon, breast, and lung. We abstracted race/ethnicity, age, country/geographic region, and hazard ratios (HRs) from references indexed in the NCCN Guidelines. Race/ethnicity and age information was obtained from baseline characteristics tables in reported studies. The country/geographic region from which participants were recruited was acquired from each individual trial’s National Clinical Trial (NCT) number, linked to clinicaltrial.gov or the main manuscript. Each study was also assessed for its reporting of survival outcomes based on race/ethnicity, age, and country. Results: A total of 31 studies reporting on 36 regimens were examined for this review. While all studies reported age, only 39% (n=12) included characterization of older adults (60 years or older). 52% provided information on the racial and ethnic makeup of the study sample. Countries where participants were recruited were mostly not reported in the main papers, rather they were identified from ClinicalTrials.gov. Also, while 67% of all studies (n=25) included an international sample, only 5% reported the country or geographic location in the main manuscript. Few studies reported efficacy by patient sub-population. 12 of the 31 (39%) manuscripts reported HRs by age. Of the 16 manuscripts reporting race/ethnicity, 16% included HRs by race/ethnicity. Only one study reported efficacy outcomes by country. Conclusions: There is a need to have a standardized system for reporting baseline characteristics as well as trial outcomes for clinical trials. Including information on subgroup-specific baseline and efficacy outcomes in clinical trial results is an inexpensive way of improving the quality of information available to oncologists and will aid them in making evidence-based treatment decisions for the entirety of their patient populations.