Effort required in eligibility screening for clinical trials.

PURPOSE Determining eligibility for a clinical trial (CT) typically requires a lengthy manual review of data for a single evaluation. The cost associated with eligibility screening is typically not compensated through contracts supporting CTs. METHODS We used a real-time tracking system that captures CT evaluations and provides information on evaluation outcomes and time spent on each eligibility screening by research staff. Using these data, we describe the effort and costs of eligibility screening overall and per enrolled patient for cancer CTs. The study sample included all completed eligibility assessment (evaluation) records for the 18-month study period. We used generalized multinomial modeling to predict evaluation outcomes and then used the resulting parameter coefficients to estimate the effort associated with each participant, adjusted for probability of being enrolled. From these data, we calculated cost associated with eligibility screening. RESULTS We found substantial variation in attributed cost by study type and phase. The cost of eligibility screening ranged by study phase from $129.15 to $336.48 per enrolled patient. The estimated annual cost of screening was more than $90,000. CONCLUSION This study provides results based on prospectively captured effort to estimate the largely nonreimbursed costs of eligibility screening and suggests that screening can be a significant financial burden to an institution. Centers performing CTs may need to acknowledge the differences in screening costs for different study types when negotiating contracts with funding organizations. Information such as that captured here could support such negotiations to reduce the gap between reimbursed and nonreimbursed costs.