Examining Factors Affecting Clinical Trial Enrolment in the Clinical Trials Navigator Program

Introduction Oncology clinical trial accrual rates are estimated to be around 5%. The Clinical Trials Navigator (CTN) Program helps oncology patients identify clinical trials. We analyzed program and patient characteristics to determine features of successful enrolment. Methods A retrospective study was conducted, analyzing 411 CTN records from March 2019 to April 2024. 73 were referred to a clinical trial, with 14 successfully enrolled. Demographic and program characteristics were analyzed for the enrolled and non-enrolled. The reason for non-enrolment was recorded. For the enrolled, trial characteristics were recorded. All comparative values were analyzed using a Welch’s T-test. Results The average age for the enrolled group was 61 years, and non-enrolled 57 years (p=0.154). The mean distance from home center to clinical trial site was 332.9 kilometers (km) for enrolled and 407.6 km for non-enrolled (p= 0.152). The CTN processing time for the enrolled group had a mean time of 4.1 days and the non-enrolled had a mean time of 12.5 days (p= 0.002). The mean time of initial CTN application to death for the enrolled group was 17.4 months and the non-enrolled was 7.9 months. (p= 0.0051). The reason for non-enrolment was found to be either or centre specific (60.1%) or patient specific (39.9%). Patient enrolment by trial phase: three phase I (21%), two phase I/II (14%), three phase II (21%), one phase II/III (7%), one phase III (7%), and four NGS (29%). Conclusion These findings highlight some of the unique barriers and opportunities for patients in patient-centered clinical trials enrolment.