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.

Keywords::

• adherence
• clinical trial
• cost–effectiveness analysis
• pharmacoeconomic analysis
• protocol-driven costs

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.