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Sample sizes in dosage investigational clinical trials: a systematic evaluation
Ji-Han Huang1, Qian-Min Su2, Juan Yang1
1Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Drug Design, Development and Therapy
|January 23, 2015
Summary
Determining appropriate sample sizes for phase II clinical trials remains unclear. This review of dose-finding studies found most trials use fewer than 40 participants per group, with parallel designs favoring larger sample sizes.
Area of Science:
- Clinical Pharmacology
- Drug Development
- Biostatistics
Background:
- Phase II clinical trials are crucial for exploring drug indications and effective doses.
- Current literature lacks clear guidelines for determining optimal sample sizes in phase II dose-finding studies.
Purpose of the Study:
- To investigate the sample sizes utilized in phase II dose-finding and dose-response clinical trials.
- To identify trends in sample size selection based on study design.
Main Methods:
- Systematic review of clinical trials registered on ClinicalTrials.gov.
- Keywords used: "dose-finding", "dose-response", and "Phase II".
- Data collected from September 20, 1999, to December 31, 2013, including 2103 trials.
Main Results:
- 55.0% of reviewed trials (1,156) had fewer than 40 participants per group.
- Only 17.2% of trials included more than 100 patients per group.
- Parallel designs (median 151 participants) used larger sample sizes than crossover designs (median 37 participants).
Conclusions:
- Phase II drug development employs diverse designs for dosage studies.
- Sample size selection requires careful consideration of study design and objectives.
- Further research may be needed to establish evidence-based sample size recommendations.
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