5 Pragmatic Free Trial Lessons From The Pros

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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are usually characterized by a focus on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of standard equipment.

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A practical trial that employs various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and also helps reduce bias in the results. However too much heterogeneity could cause problems with the design of the trial.

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The goal of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. Usually, they are ordered by policymakers and practitioners to guide their decisions. They can be used to determine the causality of an intervention and its effects. However, they should not be used to substitute for explanation trials.

The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials, which inform the policy and practice of. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a practical trial, including recruitment, design and delivery of the intervention, and follow-up.

The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.