Data standards for clinical endpoints in cardiovascular disease: A literature review protocol

The appropriate a priori selection of outcomes used in clinical research is essential for meaningful and unbiased research, and for drug and device monitoring. Registry-based randomised clinical trials are becoming increasingly common, and provide opportunities for efficient study delivery and gaining new insights into a range of health conditions. This requires a clear understanding of what clinical endpoints are currently in use for studies of people with cardiovascular disease, and also of how robust the evidence is supporting such clinical endpoints.

This systematic review aims to identify the clinical endpoints that are used in contemporary major randomised clinical trials and multicentre observational studies of cardiovascular disease, examine their definitions, and assess the extent of heterogeneity to inform whether there is a need to develop harmonised definitions of these endpoints.