Use of a clinical trial screening tool to enhance patient accrual

Background Clinical trial patient accrual continues to be challenging despite the identification of multiple physician, patient, and system barriers. Expanded collection of demographic data, including socioeconomic status (employment, income, education) and comorbidities, can enhance our understanding of the identified barriers, inform the development of interventions to overcome these barriers, and recognize their impact on treatment outcomes. A clinical trials screening tool was developed to collect expanded demographic data and barriers to trial enrollment; it has been implemented in the National Cancer Institute Clinical Oncology Research Program. The purpose of this article is to describe the development and implementation of the tool and to share information obtained during the first 43 months of its use. Methods There were 19,373 entries collected; 74% of those screened enrolled in a clinical trial. Demographic characteristics were compared between those screened and those enrolled. They varied significantly between the groups. Results Reasons for nonenrollment included ineligibility (50%), eligible but declined (47%), eligible but physician declined to offer participation (2%), and eligible but the study was suspended (1%). The most common reasons for ineligibility were failure to meet the protocol-specific stage of cancer, the presence of comorbidities, and the symptom-eligibility score was not met. The most common reason for eligible patients declining participation was that they had no desire to participate in research. Conclusions The tool provides valuable information about the characteristics of individuals who are screened and enrolled in National Cancer Institute-sponsored trials, as well as about barriers to enrollment in trials. The data also inform protocol development and interventions at the patient, provider, and institutional level.

Automated summary

This article describes the development and implementation of a clinical trials screening tool for collecting expanded demographic data and barriers to trial enrollment, and shares information obtained during the first 43 months of its use. Analysis of the results shows that the main reasons for non-enrollment include ineligibility, refusal to participate, physician not offering participation, and study suspension, while the main reasons for ineligibility are failure to meet the protocol-specific stage of cancer.