Unpacking Trial Offers and Low Accrual Rates: A Qualitative Analysis of Clinic Visits With Physicians and Patients Potentially Eligible for a Prostate Cancer Clinical Trial

Abstract

PURPOSE: Cancer clinical trial accrual rates are low, and information about contributing factors is needed. We examined video-recorded clinical interactions to identify circumstances under which patients potentially eligible for a trial at a major cancer center were offered a trial. METHODS: We conducted a qualitative directed content analysis of 62 recorded interactions with physicians (n = 13) and patients with intermediate- or high-risk prostate cancer (n = 43). Patients were screened and potentially eligible for a trial. We observed and coded the interactions in 3 steps: (1) classification of all interactions as explicit offer, offer pending, trial discussed/not offered, or trial not discussed; (2) in interactions with no explicit offer, classification of whether the cancer had progressed; (3) in interactions classified as progression but no trial offered, identification of factors discussed that may explain the lack of an offer. RESULTS: Of the 62 interactions, 29% were classified as explicit offer, 12% as offer pending, 18% as trial discussed/not offered, and 39% as trial not discussed. Of those with no offer, 57% included information that the cancer had not progressed. In 68% of the remaining interactions with patients whose cancer had progressed but did not receive an offer, reasons for the lack of offer were identified, but in 32%, no explanation was provided. CONCLUSION: Even in optimal circumstances, few patients were offered a trial, often because their cancer had not progressed. Findings support professional recommendations to broaden trial inclusion criteria. Findings suggest accrual rates should reflect the proportion of eligible patients who enroll.

Addressing multilevel barriers to clinical trial participation among Black and White men with prostate cancer through the PACCT study

“…Such strategies could improve inclusiveness, access and enrollment, thereby improving the generalizability of results and accelerating the pace of scientific progress 39,41 . Additionally, findings suggest that published enrollment rates should consider not only all patients, but also all eligible patients as a meaningful denominator, thus providing more accurate data on the sources of low enrollment and potential intervention targets 42 …”

Feasibility of Randomized Controlled Trials for Cancer Drugs Approved by the Food and Drug Administration Based on Single-Arm Studies

“…Additionally, the SEER database provides a close estimate of cancer statistics, and like any registry, underreporting is a caveat. Although difficulties exist with patient accrual to RCTs, here, duration to complete RCT was calculated based on the conservative accrual rate of 5% of all eligible US patients ( 25 ). Recent data suggest that enrollment into clinical trials is improving with estimated accrual of about 16% in academic centers and 7% in the community ( 7 , 26 ).…”

A Review of Research on Disparities in the Care of Black and White Patients With Cancer in Detroit

“…Racial disparities in patient-physician communication are well-documented and have been associated with racial disparities in cancer treatment and mortality (56,57). In research that used video-recordings of patient-physician treatment discussions (after written consent) (58), PSDR researchers have investigated disparities in clinical communication during interactions between non-Black oncologists and their Black patients (59)(60)(61)(62). They have also studied the influence of race-based attitudes (e.g., oncologist implicit racial bias, patient suspicion of medical care) on those interactions (61,62).…”