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Published on: September 20, 2019
Effort required in eligibility screening for clinical trials
Lynne T Penberthy1, Bassam A Dahman, Valentina I Petkov
1Virginia Commonwealth University, Richmond, VA, USA. lpenbert@vcu.edu
Journal of Oncology Practice
|April 20, 2013
Summary
Clinical trial (CT) eligibility screening is costly, with per-patient costs ranging from $129 to $336. This significant financial burden highlights the need for better contract negotiations to cover screening expenses.
Area of Science:
- Clinical research operations
- Health economics
- Biomedical informatics
Background:
- Eligibility screening for clinical trials (CTs) is a manual, time-consuming process.
- The costs associated with this screening are often not reimbursed through standard CT contracts.
Purpose of the Study:
- To quantify the effort and financial costs of CT eligibility screening.
- To analyze cost variations based on study type and phase.
- To inform contract negotiations by highlighting non-reimbursed screening expenses.
Main Methods:
- Utilized a real-time tracking system to capture CT evaluation outcomes and staff time spent on screening.
- Analyzed 18 months of eligibility assessment data.
- Employed generalized multinomial modeling to estimate effort per participant and calculate associated costs.
Main Results:
- Eligibility screening costs varied significantly by study phase, ranging from $129.15 to $336.48 per enrolled patient.
- The estimated annual cost for screening exceeded $90,000.
- Identified substantial differences in screening costs across different study types.
Conclusions:
- Eligibility screening represents a significant, often non-reimbursed, financial burden for institutions conducting CTs.
- Institutions should consider study-specific screening costs when negotiating contracts.
- This data can support negotiations to better align reimbursed and non-reimbursed costs.
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