Trends in Utilization of Surrogate Endpoints in Contemporary Cardiovascular Clinical Trials

Abstract Surrogate endpoints facilitate trial efficiency, but are variably linked to clinical outcomes and limited data are available exploring their utilization in cardiovascular clinical trials over time. We abstracted data regarding primary clinical, intermediate, and surrogate endpoints from all...

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Bibliographic Details
Published in:The American journal of cardiology 2016-06, Vol.117 (11), p.1845-1850
Main Authors: Patel, Ravi B., MD, Vaduganathan, Muthiah, MD MPH, Samman-Tahhan, Ayman, MD, Kalogeropoulos, Andreas P., MD MPH PhD, Georgiopoulou, Vasiliki V., MD, Fonarow, Gregg C., MD, Gheorghiade, Mihai, MD, Butler, Javed, MD MPH MBA
Format: Article
Language:English
Subjects:
Acute coronary syndromes
Biomarkers - metabolism
Cardiology
Cardiovascular
Cardiovascular disease
Cardiovascular Diseases - metabolism
Classification
Clinical trials
Clinical Trials as Topic
Coronary vessels
Endpoint Determination - methods
Enrollments
Funding
Heart attacks
Heart failure
Humans
Hypertension
Hypotheses
Impact factors
Internal medicine
Journal Impact Factor
Laboratories
Lipids
Medicine
Mortality
Stroke
Studies
Thromboembolism
Trends
Variance analysis
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Summary:Abstract Surrogate endpoints facilitate trial efficiency, but are variably linked to clinical outcomes and limited data are available exploring their utilization in cardiovascular clinical trials over time. We abstracted data regarding primary clinical, intermediate, and surrogate endpoints from all phase II-IV cardiovascular clinical trials from 2001 to 2012 published in the 8 highest Web of Science impact factor journals. Two authors independently classified type of primary endpoint. Of the 1,224 trials evaluated, 677 (55.3%) primary endpoints were clinical, 165 (13.5%) intermediate, and 382 (31.2%) surrogate. The relative proportions of these endpoints remained constant over time (p=0.98). Trials using surrogate endpoints were smaller (187 vs. 1,028 patients) and enrolled patients more expeditiously (1.4 vs. 0.9 patients per site per month) compared to trials using clinical endpoints [p
ISSN:0002-9149
1879-1913
DOI:10.1016/j.amjcard.2016.03.021