Pragmatic Trials

Approximately one-third of pragmatic trials are conducted in a single center. These single-center trials do not generally have generalizable results. However, there are a few reasons why single-center pragmatic trials may still be considered pragmatic.

The first reason is the absence of randomization. The absence of randomization can lead to biases. A pragmatic randomized controlled trial may remove these biases. The second reason is that the trials may have similar considerations. For example, they may be used by pharmaceutical manufacturers in reimbursement discussions and by end users to inform decision makers. Depending on the clinical research, the degree of pragmatism may vary.

The third reason is that pragmatic trials may be used by public sponsors as evidence that the intervention has been studied in the real world. This is particularly true for non-regulated interventions, such as cognitive behavior, diet, exercise and acupuncture. These interventions can be compared with real-world approaches to follow-up, recruitment and flexibility.

A pragmatic trial is a study that assesses whether an intervention is likely to be effective in a given population. Generally speaking, pragmatic trials can be divided into two categories: late development trials and early development trials. Early development trials are often referred to as “defying pragmatism.” Late development trials can be referred to as “informal pragmatism.” A trial that defies pragmatism is a trial that is designed to convey a misleading message to patients. Defying pragmatism is a trial conducted in a non-randomized manner that is overtly deviating from usual care.

Pragmatic trials on medicines may also have similar considerations. For example, pragmatic trials on medicines may be used by pharmaceutical manufacturers to inform decision makers and end users about the use of the medicine. In these cases, it is important to conduct the trials in a heterogeneous population, as well as in a variety of settings. The results of these trials should be relevant to a variety of settings, and should be based on actual practice.

Pragmatic RCTs on medicines should be conducted in a variety of settings. For example, they should be conducted in an heterogeneous population, in different sites, and in both regulated and non-regulated settings. Moreover, the results of a pragmatic trial should be applicable to a variety of settings, and they should be based on actual practice. The degree of pragmatism may vary depending on the protocol, as well as on subsequent protocol modifications.

One way to assess the degree of pragmatism of a trial is to use the PRECIS-2 tool. The PRECIS-2 tool is an assessment tool for randomized clinical trials (RCTs). It comprises nine scored domains. The tool can assess pragmatism before, during, and after the conduct of the trial. The tool is reasonably discriminant, has good interrater reliability, and has reasonable discriminant validity.

The PRECIS-2 tool assessment should be publicly disclosed and should include information that may not be commonly reported in manuscripts. For example, it should include information that supports adjudicated scores, and should also explain why the trial was labeled as pragmatic. It should also provide information about future enhancements to the PRECIS-2 tool.