Explanatory and pragmatic clinical trials

Methodological differences

Abstract

Introduction: clinical trials are experimental studies whose results can lead to the best level of evidence expected for healthcare practice; however, their designs have multiple methodological variants needed to ensure their objectives are met.

Objective: to describe the methodological aspectsto be considered in designing explanatory and pragmatic clinical trials.

Materials and methods: a review of the literature including articles published from 2016-2020: original or review articles describing the methodological aspects of clinical trials. The search and selection were performed on Google Scholar, Scopus and PubMed, obtaining a total of 47 articles for the analysis.

Results: six relevant methodological aspects show differences in clinical trial design with regard to: the purpose and objective; participant recruitment; participant assignment; masking and/or blinding; data analysis; and internal and external validity.
Conclusion: both types of clinical trials currently have benefits and barriers to overcome for their performance in the clinical setting; health researchers must have a detailed understanding of their methodological requirements to enable them to carry out these types of studies more accurately.