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Updated: Jul 17, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Treatment Effect Estimates From Pilot Trials Are Unreliable.

Jesse D Troy1, Megan L Neely1, Gina-Maria Pomann1

  • 1Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA.

Journal of Pain and Symptom Management
|September 4, 2023
PubMed
Summary

Pilot trials are unreliable for assessing treatment efficacy due to sampling variability. Computer simulations show that these small studies often yield misleading results, incorrectly suggesting harm or benefit, and should not guide treatment development decisions.

Keywords:
Clinical trialsPilot studiesStatistics and research methods

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