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Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical
Rhiannon T Edwards1, Barry Hounsome, Pat Linck
1Centre for Economics and Policy in Health, Institute of Medical and Social Care Research, Bangor University, Dean Street, Bangor, UK. r.t.edwards@bangor.ac.uk
Trials
|November 19, 2008
Summary
Pragmatic trials best support economic evaluation. Developing a standard operating procedure (SOP) for economic evaluation alongside pragmatic trials is crucial, yet currently uncommon among UK Clinical Research Collaboration (UKCRC) registered units.
Area of Science:
- Health economics
- Clinical trial methodology
- Research administration
Background:
- Pragmatic randomized trials are recognized as optimal for economic evaluations due to strong internal validity and efficient data collection.
- Collecting economic data alongside clinical data in trials is cost-effective.
- The UK Clinical Research Collaboration (UKCRC) does not mandate a standard operating procedure (SOP) for economic evaluations for trial unit registration.
Purpose of the Study:
- To highlight the importance of integrating health economics into clinical trials.
- To advocate for the requirement of a dedicated SOP for economic evaluations in pragmatic trials.
- To address the gap in current UKCRC registration requirements.
Main Methods:
- A collaboration between health economists and trialists developed a specific SOP for economic evaluation in pragmatic trials.
- This SOP complements the existing twenty SOPs required by UKCRC for trial unit registration.
- A telephone survey was conducted to assess the current prevalence of economic SOPs in UKCRC-registered trials units.
Main Results:
- The developed SOP is an addition to the twenty standard operating procedures mandated by UKCRC.
- A recent survey indicated that no other UKCRC-registered trials unit currently possesses a dedicated SOP for economic evaluation.
- This suggests a significant gap in standardized economic evaluation practices within registered trials units.
Conclusions:
- The UK Clinical Research Collaboration (UKCRC) should mandate a SOP for economic evaluation for all Trials Units seeking registration or re-registration.
- Implementing such a SOP would enhance the rigor and integration of health economics in pragmatic trials.
- Standardization of economic evaluation procedures is essential for robust trial outcomes.
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