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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Study design considerations for a large simple trial of bisphosphonates
Nicole C Wright1, Amy H Warriner, Kenneth G Saag
1Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama 35294, USA. ncwright@uab.edu
Current Opinion in Rheumatology
|May 10, 2013
Summary
Designing large simple trials (LSTs) for osteoporosis requires careful consideration of comparative effectiveness research challenges. Properly designed LSTs offer generalizable, real-world insights into osteoporosis treatments.
Area of Science:
- Osteoporosis research
- Clinical trial design
- Comparative effectiveness
Background:
- Growing need for comparative effectiveness studies in osteoporosis.
- Challenges in designing osteoporosis trials include study design, comparator selection, participant and outcome selection, data acquisition, and analysis.
Purpose of the Study:
- Evaluate design considerations for osteoporosis large simple trials (LSTs).
- Propose novel approaches for LSTs in osteoporosis comparative effectiveness research.
Main Methods:
- Review of design aspects for large simple trials in osteoporosis.
- Discussion of bisphosphonate active comparator initiation and discontinuation trials.
- Analysis of advantages and disadvantages of various design elements.
Main Results:
- Comparative effectiveness studies in osteoporosis face design challenges.
- Large simple trials (LSTs) can achieve high generalizability when designed appropriately.
Conclusions:
- Properly designed LSTs are crucial for generalizable osteoporosis research.
- Novel approaches are proposed to address challenges in osteoporosis comparative effectiveness research using LSTs.
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