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Power and sample size for cost-effectiveness analysis: fFN neonatal screening.

Kathleen A Boyd¹, Andrew H Briggs, Elisabeth Fenwick

¹University of Glasgow, Glasgow, UK. Kathleen.Boyd@glasgow.ac.uk

Contemporary Clinical Trials

|July 26, 2011

Summary

Calculating sample sizes for cost-effectiveness in clinical trials is feasible using the net monetary benefit approach. This method ensures trials are powered for economic outcomes, not just effectiveness, guiding trial design and non-inferiority margins.

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Area of Science:

Health economics
Clinical trial design
Biostatistics

Background:

Randomised controlled trials (RCTs) with cost-effectiveness evaluations often neglect health economic input for sample size calculations.
Sample size calculations should align with cost-effectiveness outcomes when it's the primary endpoint.

Purpose of the Study:

Demonstrate the feasibility of sample size calculation for cost-effectiveness in a real-world setting using the net monetary benefit (NMB) approach.
Propose a framework for integrating economic considerations into clinical trial design.

Main Methods:

Utilized the net monetary benefit (NMB) approach for cost-effectiveness analysis.
Calculated sample sizes for a proposed RCT of fetal fibronectin screening (fFN) for threatened pre-term labour.

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Performed probabilistic analysis to explore parameter uncertainty and its impact on sample size.

Main Results:

The NMB approach was used to calculate required sample sizes for various statistical powers.
Sample size calculations were adjusted using a non-inferiority margin to ensure effectiveness endpoint sufficiency.
Pre-trial predictions indicated potential cost-savings with a minor negative impact on neonatal morbidity.

Conclusions:

Economic assessments should guide conventional clinical trial design.
The NMB approach is feasible for determining sample sizes in cost-effectiveness studies.
Economic considerations can effectively guide the establishment of non-inferiority margins.