“These disparities are concerning as the generalizability of clinical trial results relies on the assumption that the population of patients included in a clinical trial represents the overall population of patients with the disease," says Brian M. Shinder, MD.
A recent study found that certain sociodemographic factors were associated with clinical trial participation for patients with renal cell carcinoma (RCC).1 The findings were published in Urologic Oncology.
Using data from the National Cancer Database, the investigators identified 681 patients with RCC who were enrolled in clinical trials from 2004 to 2014. The study was conducted using a matched case-control design with a total of 3405 controls. Participants were matched in a 1:5 ratio to compare sociodemographic factors and in a 1:10 ratio based on age, clinical stage, and comorbidities.
The mean age was 56.4 years among trial participants and 63.5 years among control participants (P < .0001).Patients enrolled in clinical trials tended to travel a longer distance to receive treatment versus controls (P < .0001). More patients in the trial group also had a Charlson-Deyo comorbidity score of 0 (P < .0001) compared with the control group.
Upon multivariate analysis, patient characteristic comparisons showed that clinical trial participants were more likely to be male (P = .009), White (P = .001), or live in an area code where more than 93% of adults had at least a high school degree (P = .013). Patients who were uninsured (P = .039), had Medicare (P < .0001), or had Medicaid (P = .0009) were significantly less likely to participate in clinical trials compared with those with private insurance.
“These disparities are concerning as the generalizability of clinical trial results relies on the assumption that the population of patients included in a clinical trial represents the overall population of patients with the disease. Therefore, our results highlight a potential pitfall of RCC clinical trials and suggest that work needs to be done to improve enrollment of these underrepresented groups,” said lead author Brian M. Shinder, MD, in correspondence with Urology Times. Shinder is a urologic oncology fellow at Memorial Sloan Kettering Cancer Center in New York.
The investigators also found that median overall survival (OS) was greater in patients enrolled in clinical trials. Among patients with stage 3 or 4 disease, OS was 65.5 months in the trial cohort compared with 32.6 months for the control cohort (P < .0001). The investigators recognized that these findings could be related to the sociodemographic factors associated with trial participation (insurance status, ability to travel, etc.) which may increase access to the complex US healthcare system.
Shinder concluded, “Awareness of such factors that are associated with lower clinical trial participation should help investigators devise solutions to limit these disparities. Greater outreach to the patient populations who are underrepresented in clinical trials would be prudent to increase their awareness and acceptance of clinical trial participation. Furthermore, working with clinical trial sponsors and funding agencies to limit the costs of trial participation may assist in the recruitment of patients with a lower socioeconomic status given the increased financial burden sometimes placed on study subjects.”
1. Shinder BM, Kim S, Srivastava A, et al. Factors associated with clinical trial participation for patients with renal cell carcinoma. Urol Oncol. 2023;S1078-1439(23)00053-4.doi: 10.1016/j.urolonc.2023.01.022.