What we want versus what we can get: a closer look at failure time endpoints for cardiovascular studies

Area of Science:

• Clinical Trials Methodology
• Biostatistics
• Epidemiology

Background:

• All-cause mortality is a common primary endpoint in clinical trials.
• Composite endpoints are frequently used but can present interpretation challenges.

Purpose of the Study:

• To review the current use of all-cause mortality and composite endpoints.
• To propose a recurrent composite endpoint as a novel primary endpoint alternative.
• To provide guidance for clinical trialists and practitioners.

Main Methods:

• Literature review of primary endpoint selection in clinical trials.
• Conceptual proposal of a recurrent composite endpoint.
• Discussion of practical implications for trial design and analysis.

Main Results:

• Current practices regarding primary endpoints require clarification.
• Recurrent composite endpoints offer a potential improvement for specific trial designs.
• Guidance is offered to enhance the rigor of endpoint selection.

Conclusions:

• The selection and interpretation of primary endpoints, particularly composite endpoints, need further standardization.
• Recurrent composite endpoints represent a promising area for future research and application in clinical trials.
• Clearer guidelines are essential for optimizing the design and reporting of clinical trials.