A fundamental component of a study’s methodology is the determination of primary and secondary outcomes. The definition of these endpoints is critical: the primary outcomes serve as the principal measures by which efficacy or harm of an intervention is evaluated, and secondary outcomes provide valuable insights into broader impacts of the study, and potentially reveal new avenues for future investigation. This distinction is especially important in cardiovascular trials, where standardised outcome measures are essential for consistency and comparability. Recognising this need, the US Food and Drug Administration established the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) in 2009. This initiative aimed to streamline the design and execution of cardiovascular clinical trials by developing standardised definitions for key clinical endpoints. By promoting uniformity in outcome definitions, the SCTI facilitates the aggregation of data across studies, enhances the comparability of intervention effectiveness and supports more robust meta-analyses.1 2 In 2017, a formal document from the group was published with the aim of standardising such endpoint definitions. However, uptake of these standardised definitions has not been uniform.
Bhatty et al presented a systematic review of clinical outcomes based on published cardiovascular phase 3 or 4 randomised clinical trials (RCTs) or multicentre observational studies in three high-impact journals (New England Journal of Medicine, Lancet or Journal …
