The purpose of including primary and secondary endpoints in a protocol is to:

The inclusion of primary and secondary endpoints in a research protocol plays a crucial role in clarifying the research objectives and outcomes. Primary endpoints refer to the main outcomes that the study aims to evaluate, serving as the principal measure of the effectiveness of an intervention. They guide the primary focus of the analysis and significantly influence the study’s design and sample size calculations.

Secondary endpoints, on the other hand, are additional outcomes that may provide further insight into the effects of the intervention but are not the main focus of the study. They can help explore additional dimensions of the research question and contribute to a more comprehensive understanding of the intervention's impact.

By clearly outlining these endpoints, researchers ensure that the study's goals are well-defined, facilitating precise measurement and interpretation of the results. This clarity is essential for stakeholders, including researchers, participants, and regulatory bodies, as it establishes a roadmap for the research process and allows for consistent evaluation against the stated objectives.