2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

Area of Science:

• Cardiology
• Clinical Trials
• Regulatory Science

Background:

• Clinical trials for cardiovascular and stroke outcomes require consistent data collection.
• The U.S. Food and Drug Administration (FDA) established an initiative to standardize data collection.
• Existing methods may lack uniformity, impacting data aggregation and analysis.

Purpose of the Study:

• To describe uniform definitions for cardiovascular and stroke outcomes.
• To simplify the design and conduct of clinical trials supporting marketing applications.
• To provide standardized definitions for potential use in clinical care processes.

Main Methods:

• Development of uniform definitions by the Standardized Data Collection for Cardiovascular Trials Initiative and the FDA.
• Review and consensus on outcome definitions for cardiovascular and stroke events.
• Consideration of applicability beyond marketing applications.

Main Results:

• Uniform definitions for cardiovascular and stroke outcomes have been established.
• FDA use of these definitions enhances data aggregation across development programs.
• These definitions facilitate meta-analyses for cardiovascular safety and comparative effectiveness of drugs and devices.

Conclusions:

• Standardized definitions improve the ability to aggregate and analyze cardiovascular trial data.
• The definitions support meta-analyses and comparisons of medical products.
• Further research is needed to confirm if prospective data collection with these definitions enhances trial design and interpretability.