A novel approach to assessing disparity in representativeness of clinical trial participants within a large midwestern healthcare system

Autor: Anne Rivelli, Cheryl Lefaiver, Maureen Shields, Osondi Ozoani-Lohrer, Andy Marek, Jana Hirschtick, Veronica Fitzpatrick
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Contemporary Clinical Trials Communications, Vol 38, Iss , Pp 101274- (2024)
Druh dokumentu: article
ISSN: 2451-8654
DOI: 10.1016/j.conctc.2024.101274
Popis: Background: Representativeness in clinical trials (CT) serves as a metric of access to healthcare and reflects differences that may determine differential efficacy of medical interventions; thus, quantifying representativeness in CT participation is critical. Methods: This retrospective, descriptive study utilized patient demographic data extracted from the largest Midwestern non-profit healthcare system. Using data between January 1, 2019 and December 31, 2021, a CT Participant Sample of 4,537 system patients who were active CT participants was compared to a CT Patient Population of 195,726 system patients receiving care by the PI of active CTs, which represented the target population. Chi-square goodness-of-fit tests were used to test differences in distributions of demographic variables between groups, indicating disparity in CT participation. Two metrics adapted from literature - participation incidence disparity (PID) and participation incidence ratio (PIR) - were calculated to quantify absolute and relative disparity in representativeness proportions, respectively. Descriptive approaches to assessing representativeness are also provided. Results: Results showed significant differences by race/ethnicity (χ2 = 50.64; p
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