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The problem of protocol driven costs in pharmacoeconomic analysis.
1Clinical Epidemiology Unit, Loeb Research Institute, Ottawa Civic Hospital, Ontario, Canada. dcoyle@lri.ca
Pharmacoeconomics
|May 27, 1999
Summary
Economic evaluations linked to clinical trials are rising, but study quality is not. Protocol-driven costs in trials threaten generalizability, requiring better reporting and methods for accurate healthcare economic analysis.
Area of Science:
- Health Economics
- Clinical Trial Methodology
- Pharmacoeconomics
Background:
- Economic evaluations of healthcare interventions, especially drug therapies, are increasing.
- Study quality in economic evaluations has not kept pace with the increase in volume.
- Concerns exist regarding the external validity and generalizability of economic analyses linked to randomized controlled trials (RCTs).
Purpose of the Study:
- To identify and discuss protocol-driven costs as a threat to the external validity of economic evaluations based on RCTs.
- To explore methods for controlling protocol-driven costs in pharmacoeconomic study designs.
- To assess the current consideration of protocol-driven costs in published studies.
Main Methods:
- Literature review to identify the existence and consideration of protocol-driven costs in published economic evaluations alongside RCTs.
- Discussion of methods to control for protocol-driven costs, including modeling with observational data and pragmatic trial designs.
- Analysis of two types of protocol-driven costs: prescribed (mandated by trial design) and derived (atypical disease management due to trial investigations).
Main Results:
- Protocol-driven costs, arising from trial designs or mandated investigations, pose a significant threat to the generalizability of economic evaluation results.
- Methods exist to mitigate these costs, such as using combined clinical trial and observational data or refining trial designs.
- A review found limited explicit consideration of protocol-driven costs in published studies, despite evidence of their presence.
Conclusions:
- Lack of transparency in reporting hinders the assessment of how protocol-driven costs are managed in current studies.
- Future economic evaluations conducted alongside RCTs must explicitly address the handling of protocol-driven costs.
- Improved methodology and reporting are crucial for enhancing the validity and generalizability of healthcare economic analyses.
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