Identifying eligible patients for clinical trials represents one of the most challenging and important components in the accrual process, yet most sponsors typically do not reimburse for the eligibility screening process.

In the November 2012 Journal of Oncology Practice (JOP) article, “Effort Required in Eligibility Screening for Clinical Trials,” authors Lynne T. Penberthy, MD, MPH; Bassam A. Dahman, PhD; Valentina I. Petkov, MD, MPH, et al., summarize their efforts using a real-time tracking system to capture clinical trial evaluations and also outline information on evaluation outcomes and time spent on each eligibility screening by research staff. Specifically, the article includes tables that outline:

• a distribution of evaluations according to patient characteristics,
• a distribution of the proportion of evaluations according to the level of effort and by nonpatient characteristics, and
• an estimated time per evaluation and per enrollment and the associated cost.

Authors concluded that “the cost of recruiting patients to [clinical trials] is high, with most studies not fully covering the cost of the trial itself.” Eligibility screening can be a significant financial burden to an institution, especially if the institution is performing early-phase clinical trials. Accordingly, the information presented in the article “could serve as a point of negotiation with sponsors to reduce the gap between reimbursed and unreimbursed costs.”

Visit jop.ascopubs.org for more information.