Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual

Abstract

Purpose: Screening logs have the potential to help oncology clinical trial programs at the site level, as well as trial leaders, address enrollment in real time. Such an approach could be especially helpful in improving representation of racial/ethnic minority and other underrepresented populations in clinical trials.

Methods: The National Cancer Institute Community Cancer Centers Program (NCCCP) developed a screening log. Log data collected from March 2009 through May 2012 were analyzed for number of patients screened versus enrolled, including for demographic subgroups; screening methods; and enrollment barriers, including reasons for ineligibility and provider and patient reasons for declining to offer or participate in a trial. User feedback was obtained to better understand perceptions of log utility.

Results: Of 4,483 patients screened, 18.4% enrolled onto NCCCP log trials. Reasons for nonenrollment were ineligibility (51.6%), patient declined (25.8%), physician declined (15.6%), urgent need for treatment (6.6%), and trial suspension (0.4%). Major reasons for patients declining were no desire to participate in trials (43.2%) and preference for standard of care (39%). Major reasons for physicians declining to offer trials were preference for standard of care (53%) and concerns about tolerability (29.3%). Enrollment rates onto log trials did not differ between white and black (P = .15) or between Hispanic and non-Hispanic patients (P = .73). Other races had lower enrollment rates than whites and blacks. Sites valued the ready access to log data on enrollment barriers, with some sites changing practices to address those barriers.

Conclusion: Use of screening logs to document enrollment barriers at the local level can facilitate development of strategies to enhance clinical trial accrual.

Figure 1.

Reasons for nonenrollment. (A) Reason(s) for ineligibility. (*) A total of 1,973 responses were provided across 1,882 of 1,886 ineligible patients. Four records did not supply reasons for ineligibility. (B) Reason(s) health care provider declined. (†) A total of 614 responses were provided across all 570 providers who declined to offer trial. (C) Reason(s) patient declined. (‡) A total of 1,091 responses were provided across all 944 patients who declined trial participation.

Figure A1.

Patients screened and enrolled, by clinical trial, in the National Cancer Institute Community Cancer Centers Program Clinical Trial Screening and Accrual Log, March 2009-May 2012. H&N, head and neck.