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Small Clinical Trials: Issues and Challenges (2001)
Institute of Medicine (IOM)

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. "2 Design of Small Clinical Trials." Small Clinical Trials: Issues and Challenges. Washington, DC: The National Academies Press, 2001.

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Because of the limitations of small clinical trials it is especially important that the results be reported with accompanying details about the sample size, sample characteristics, and study design. The details necessary to combine evidence from several related studies, for example, measurement methods, main outcomes, and predictors for individual participants, should be published. There are two reasons for this: first, it allows the clinician to appropriately interpret the data within the clinical context, and second, it paves the way for meta-analysis with other small clinical trials or other future analyses of the study, for example, as part of a sequential design or meta-analysis. In the clinical setting, the consequences might be greater if one misinterprets the results. In the research setting, insufficiently described design strategies and methods diminish the study's value for future analyses.

RECOMMENDATION: Clarify methods in reporting of results of clinical trials. In reporting the results of a small clinical trial, with its inherent limitations, it is particularly important to carefully describe all sample characteristics and methods of data collection and analysis for synthesis of the data from the research.

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