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 aspects to 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. (Acta Med Colomb 2022; 48. DOI:https://doi.org/10.36104/amc.2023.2614).

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