Conduction of Pragmatic Clinical Trials in Routine Clinical Settings: Guidelines for Development of Protocol

The relationships between treatments and real-world healthcare outcomes can be effectively evaluated through the implementation of a pragmatic clinical trial or practical clinical trial (PCT).

This trial helps to bridge the gap between clinical research and real-world practice by providing valuable insights into treatment effectiveness in routine health care settings. This article aims to present a systematic approach for developing study protocols by combining the author's real-world experience from study center and knowledge derived from existing literature.

This brief review article is based on a focused literature review and the author's academic experience in developing study protocol for academic research using PCT design. The core methodology components, such as research question formation, site selection, feasibility testing, and sample size calculation, are presented in a stepwise manner to guide protocol development.

The study outlines a structured approach that can be applied in routine health care practice. The stepwise approach aids in the systematic planning and execution of PCT, ensuring their feasibility and relevance in real-world clinical settings.

This article serves as a practical guide for future trialists and researchers interested in adopting the PCT design. It also aims to raise awareness among those unfamiliar with this approach, offering an alternative perspective beyond traditional randomized controlled trials.

CTRI/2025/03/081559.