Dr. Sean Tunis, CMTP President and CEO, was involved in the development of the Pragmatic Explanatory Continuum Indicator Summary (PRECIS). The purpose of the PRECIS tool is to provide a framework for describing and evaluating key features of trial design that researchers should consider when designing trials to meet the need of post-regulatory decision makers (patients, clinicians, payers, and policy makers). Although in general, more pragmatic clinical trials will include many of the “pragmatic” features described in the PRECIS instrument, the ultimate decision regarding specific features of trial design will depend on the research question being addressed and the evidence needs of the end user. A novel aspect of this PRECIS framework is therefore the blurry distinction between a pragmatic and explanatory randomized trial, hence the authors use a “continuum” to illustrate the fact the two are not always mutually exclusive.
Documents
For more information about the PRECIS, refer to this peer reviewed journal article,
Thorpe et all (PRECIS) (pdf) (540.6 kB)
For an example of the PRECIS tool applied to the design of a randomized trial,refer to this document,
Riddle 2010 (PRECIS) (pdf) (233.91 kB)