Wenxin (Vincent) Xu, MD from Dana-Farber Cancer Institute speaks about Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors.
Link to Abstract:
https://pubmed.ncbi.nlm.nih.gov/34124786/
Abstract:
The goal of our research was to see if there were any inequalities in clinical trial participation for certain patient categories. For each FDA-approved medication approved between January 1, 2006, and June 30, 2020, we searched the FDA database and collected phase-III clinical trial data from MEDLINE. We looked at the inclusion and exclusion criteria, as well as participation by gender, ethnic group, performance score, HBV and HCV positive, HIV, comorbidities, and brain metastases. We used data from the Surveillance, Epidemiology, and End Results (SEER) database to compare the findings to those of the general population. A total of 105 397 participants were enrolled in 142 phase III pivotal oncology studies. The percentage of female patients in trials was lower than their relative frequency in the SEER region’s general population (36% vs 49.6%, P.001). The rates of black patients included in the study were lower than the SEER region’s relative prevalence (2.1 percent vs. 9.8 percent, P.001). HBV and HCV infections were found in 1.3 percent and 0.8 percent of patients, respectively. Due to a lack of data from clinical studies, the number of patients with organ malfunction could not be determined. Controlled brain metastases was found in 1.6 percent of all patients. Patients with brain metastases or HBV and HCV were underrepresented, as were black patients, women, and patients with HBV and HCV. Our findings highlight the need of broadening the inclusion/exclusion criteria for critical cancer studies to include more patients encountered in clinical practice.