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Economic endpoints in clinical trials
John Cook1, Michael Drummond, Joseph F Heyse
1Merck Research Laboratories, Blue Bell, PA 19422, USA. john_cook@merck.com
Statistical Methods in Medical Research
|April 8, 2004
Summary
This study guides statisticians on incorporating economic endpoints into clinical trials. It covers data collection, sample size, and analysis methods for cost-effectiveness research at medicine launch.
Area of Science:
- Health Economics
- Biostatistics
- Clinical Trial Design
Background:
- Healthcare decision-makers require cost and cost-effectiveness data for new medicines at launch.
- Clinical trials are a potential source for collecting healthcare resource utilization and cost data.
Purpose of the Study:
- To discuss statistical considerations for including economic endpoints in clinical trials.
- To guide the design and analysis of trials incorporating economic data.
Main Methods:
- Review of design issues for economic endpoints in clinical trials.
- Discussion of alternative methods for collecting economic data.
- Presentation of analytical approaches for resource utilization, cost, and cost-effectiveness data.
Main Results:
- Identified key statistical challenges in designing trials with economic endpoints.
- Presented various methods for data collection and analysis.
- Demonstrated application of analytical approaches using real clinical trial data.
Conclusions:
- Appropriate statistical planning is crucial for integrating economic endpoints into clinical trials.
- The methods discussed can inform the collection and analysis of economic data for healthcare decision-making.
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