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[Clinical trials: principles of the method].

J P Aboulker1

  • 1INSERM SC10, Villejuif. jp.aboulker@vjf.inserm.fr

La Revue Du Praticien
|June 30, 2000
PubMed
Summary

Clinical reasoning has evolved over centuries, leading to the development of controlled studies and, by the 1940s, randomized clinical trials. Modern trials remain prospective, controlled, and randomized to ensure reliable therapeutic inferences.

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Area of Science:

  • Medical Research Methodology
  • Clinical Epidemiology
  • Evidence-Based Medicine

Context:

  • The historical application of comparative judgment in scientific measurement and clinical reasoning.
  • The 19th-century drive to systematize medical observation for reliable therapeutic inference.
  • The evolution from early controlled studies to the formalization of clinical trials.

Purpose:

  • To trace the historical development and methodological advancements in clinical trials.
  • To highlight the integration of statistical theories into clinical research design.
  • To underscore the foundational principles of modern clinical trial methodology.

Summary:

  • Comparative judgment, fundamental to science, has been applied to clinical reasoning for centuries.
  • The 19th century saw efforts to systematize medical observations, leading to controlled studies.
  • By the 1940s, clinical trials adopted Fisher's statistical theories, becoming a 'hard science' for causal inference, and remain primarily controlled, randomized, prospective studies today.

Impact:

  • Established clinical trials as a rigorous methodology for causal inference in therapy.
  • Enabled significant advances in clinical and therapeutic knowledge through systematic investigation.
  • Continues to shape modern medical research by emphasizing bias limitation and statistical significance.

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