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Economics in sample size determination for clinical trials
D J Torgerson1, M Ryan, J Ratcliffe
1National Primary Care Research and Development Centre, University of York.
Summary
Health economics can optimize clinical trial design by identifying economically significant outcomes. Incorporating economic factors ensures trials are efficiently sized, preventing wasted research resources.
Area of Science:
- Health Economics
- Clinical Trial Design
- Biostatistics
Background:
- Sample size determination in clinical trials typically involves statisticians and clinicians.
- Health economists are rarely involved in the sample size determination process.
- Economic significance of outcomes is crucial for efficient trial design and funding.
Purpose of the Study:
- To demonstrate how health economics can influence clinical trial sample size determination.
- To highlight the importance of considering economic significance in trial planning.
- To advocate for the integration of health economists in trial design.
Main Methods:
- Utilizing three case studies: prevention of osteoporosis, management of infertility, and endometriosis.
- Analyzing outcome changes for their economic significance.
- Applying economic principles to inform sample size calculations.
Main Results:
- Economic significance can guide the determination of appropriate clinical trial sample sizes.
- Inappropriate trial sizes (too small or too large) lead to research resource wastage.
- Health economic input can lead to more efficient and effective clinical trial designs.
Conclusions:
- Integrating health economics into clinical trial design optimizes resource allocation.
- Considering economic significance ensures trials yield meaningful and actionable results.
- Health economists play a vital role in enhancing the efficiency and impact of clinical research.