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[Explanatory or pragmatic trials, the dualism]
1Inserm U21, Villejuif, France.
Abstract:
A comparative clinical trial may have different objectives. For instance, it may be aimed at finding out whether a new drug is actually efficient in man, as suggested by the results of experimental studies: this occur when new molecules are found, or when new indications are discovered for an old drug. In such cases clinical trials are designed as laboratory experiments and the drug must be used in optimum conditions so that its efficacy can be best proven. The trial is said to have an explicative design. A different objective for a trial may be to evaluate the practical interests of a new treatment, the efficacy of which has already been proven; this treatment will then be compared to those already existing and its advantages as well as its drawbacks will have to be considered when recommendations are given. This approach requires a pragmatic design, in order to help physicians take the best therapeutic decisions (or society to take public health decisions). Finally, it is the experimental or pragmatic design of a trial which determines the choice of patients, endpoint criteria, drug regimen, follow-up and methods of comparison.
Insights
Clinical trials serve distinct purposes, focusing on proving a new drug's efficacy through explicative designs or evaluating its practical use in real-world scenarios via pragmatic designs.
Area of Science:
- Clinical trial design
- Drug efficacy evaluation
- Therapeutic decision-making
Context:
- Comparative clinical trials are essential for advancing medical treatments.
- Distinguishing between explicative and pragmatic trial designs is crucial for accurate interpretation of results.
Purpose:
- To elucidate the different objectives and designs of comparative clinical trials.
- To differentiate between explicative trials (proving efficacy under optimal conditions) and pragmatic trials (evaluating real-world utility).
Summary:
- Explicative trials focus on demonstrating a new drug's efficacy, often in ideal settings, akin to laboratory experiments.
- Pragmatic trials assess the practical value of established treatments, comparing them to existing options to inform clinical and public health decisions.
- The chosen trial design (explicative or pragmatic) dictates patient selection, outcome measures, treatment protocols, and comparison methods.
Impact:
- Informs the selection of appropriate clinical trial methodologies based on research objectives.
- Facilitates better therapeutic decision-making by physicians and public health policy.
- Enhances the understanding of how trial design influences the interpretation of drug effectiveness and real-world application.