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[From the explanatory to the pragmatic].

R Flamant

    Bulletin Du Cancer
    |January 1, 1987
    PubMed
    Summary

    Clinical trial methodology needs refinement for real-world practice. Explanatory and pragmatic trial designs offer distinct approaches, but challenges remain in assessment and analysis, with decision-making procedures as a potential solution.

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    Area of Science:

    • Clinical Research Methodology
    • Evidence-Based Medicine
    • Therapeutic Research Evaluation

    Context:

    • Classical clinical trial methodology is designed for scientific knowledge advancement.
    • This approach is often inadequate for assessing treatments within clinical practice, considering all benefits and drawbacks.
    • The need for alternative trial designs emerged in the 1970s.

    Purpose:

    • To explore the limitations of classical clinical trial methodology in evaluating treatments for practical application.
    • To introduce and differentiate between explanatory and pragmatic clinical trial approaches.
    • To identify challenges in assessment criteria and analysis methods for clinical trials.

    Summary:

    • Two distinct approaches, explanatory and pragmatic trials, were developed to address the shortcomings of classical clinical trial methodology.
    • Explanatory trials focus on efficacy under ideal conditions, while pragmatic trials assess effectiveness in routine clinical practice.
    • Difficulties in assessment criteria and analysis methods persist, hindering the optimal use of these trial designs.

    Impact:

    • The distinction between explanatory and pragmatic trials offers a valuable framework for designing more relevant clinical studies.
    • Highlights the ongoing research need for improved decision-making procedures in clinical trial analysis.
    • Aims to enhance the applicability of clinical trial findings to real-world healthcare settings.

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