Representativeness of Randomized Control Trials in Kidney Transplantation

Background: Differences between participants in randomized controlled trials (RCTs) and the target patient population may impact the intervention effect of trial findings in clinical practice. The purpose of this study was to determine the extent to which participants in clinical trials were similar to transplant recipients who underwent transplantation in the U.S. at the time of clinical trial enrolment. Methods: We undertook a systematic search of PubMed, Embase and ClinicalTrials. gov for RCTs completed between 1990 to 2020 that included adults ≥ 18 years of age in kidney transplant recipients. Trials were included if at least one U.S. center participated and ≥ 100 participants were randomized. For each trial, the inclusion and exclusion criteria were extracted and applied to the scientific registry of transplant recipients (SRTR) to identify patients undergoing transplantation during the trial enrollment period. Demographics of interest included participant age, the proportion of women, and the proportion of patients from race and ethnic minority groups. Results: Our search identified 5206 records, 43 trials met the study inclusion criteria. Participants characteristics included age, sex, race/ethnicity, cause of kidney failure, donor source, and comorbid conditions. From the trials, a total of 13591 participants enrolled. 74% enrolled patients only in the U.S., and 52% were multicenter studies. After searching each trial's inclusion and exclusion criteria during the trial enrollment period, 1,011,861 transplant recipients were identified in the SRTR who were potentially eligible for trial participation. Trial participants were younger, more likely to be White, and less likely to be Black or Asian (table 1). Demographic differences between trial participants and transplant eligible transplant recipients in the U.S. persisted in more recent trials. Conclusions: We conclude that women and non-White patients are under-represented in kidney transplant trials. These differences may limit the applicability of trial findings to the real-world setting. Efforts to improve the representativeness of transplant trials are needed. - Trial participants Mean (SD) Contemporary trial Mean (SD) P value Age (years) 47.7 (± 3.0) 49.1 (± 1.8) 0.02 Women (%) 35.7 (± 6.3) 39.0 (± 1.8) <0.01 Race (%) White 66.7 (± 18.5) 53.6 (± 3.4) <0.01 Black 20.7 (± 12.9) 26.0 (± 1.0) <0.01 Asian 5.0 (± 4.2) 5.1 (± 1.1) 0.06 Hispanic ethnicity (%) 15.0 (± 11.9) 13.6 (± 2.0) 0.6

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