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Related Experiment Videos

The consumer's risk in clinical trials.

B S Kramer1

  • 1NCI-Navy Medical Oncology Branch, National Naval Medical Center, Bethesda, MD 20814.

Molecular Biotherapy
|September 1, 1990
PubMed
Summary

Statistical testing involves two error types: Type 1 (alpha) and Type 2 (beta). This study focuses on consumer's risk (Type 2 error), often overlooked in clinical trials compared to producer's risk.

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Area of Science:

  • Biostatistics
  • Clinical Trial Methodology
  • Statistical Inference

Background:

  • Formal statistical tests of the null hypothesis involve two potential errors: Type 1 (alpha) and Type 2 (beta).
  • Type 1 error occurs when the null hypothesis is wrongly rejected (false positive).
  • Type 2 error occurs when the null hypothesis is wrongly accepted (false negative).

Purpose of the Study:

  • To highlight the significance of Type 2 errors, conceptualized as consumer's risk.
  • To address the underemphasis of consumer's risk in clinical trial reporting.
  • To identify and discuss potential sources contributing to consumer's risk.

Main Methods:

  • Conceptual analysis of statistical error types in hypothesis testing.
  • Review of common practices in clinical trial reporting.
  • Identification of factors contributing to Type 2 errors.

Main Results:

  • Type 1 error is often termed producer's risk, while Type 2 error is consumer's risk.
  • Clinical trial reports frequently emphasize producer's risk.
  • Numerous potential sources of consumer's risk exist but are often not detailed.

Conclusions:

  • Consumer's risk (Type 2 error) is a critical consideration in statistical testing and clinical trials.
  • A greater focus on understanding and mitigating consumer's risk is warranted.
  • Further research into the sources and implications of consumer's risk is needed.

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