title: Protocol-driven costs in trial-based pharmacoeconomic analyses.
abstract: Many authors and guidelines have proposed to exclude protocol-driven costs from cost-effectiveness analyses alongside clinical trials because they do not occur in clinical practice. This article, however, argues that only costs to improve patient adherence can be excluded, as the underlying protocol-driven activities have a clearly distinguishable cost and utility impact (most of the time). All other protocol-driven costs need to be included because the cost and utility impact of the underlying protocol-driven activities cannot be easily separated.
authors.affiliation: Frankfurt School of Finance and Management, Frankfurt, Germany. a.gandjour@fs.de
authors.forename: Afschin
authors.initials: A
authors.lastname: Gandjour
mesh_terms: D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000191:economics* / Q000592:standards; D003362:Cost-Benefit Analysis; D003625:Data Collection / Q000191:economics; D003955:Diagnostic Tests, Routine / Q000191:economics; D017850:Economics, Pharmaceutical; D017048:Health Care Costs; D006801:Humans; D055118:Medication Adherence; D018803:Models, Economic; D011785:Quality Assurance, Health Care / Q000191:economics; D012107:Research Design / Q000592:standards