2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
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This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.
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Efforts to standardize the identification of events by adjudication typically exclude many events that are regarded as clinically meaningful by the treating physician.
“efforts to standardize the identification of events by the process of adjudication typically exclude many events that are regarded as clinically meaningful by the treating physician.11–14”
From Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial (2021) · cites this paper as [11]
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Self-citation
- Authors
- Hicks, K. A., Mahaffey, K. W., Mehran, R., Nissen, S. E., Wiviott, S. D., Dunn, B., Solomon, S. D., Marler, J. R., Teerlink, J. R., Farb, A., Morrow, D. A., Targum, S. L., Sila, C. A., Hai, M. T. T., Jaff, M. R., Joffe, H. V., Cutlip, D. E., Desai, A. S., Lewis, E. F., Gibson, C. M., Landray, M. J., Lincoff, A. M., White, C. J., Brooks, S. S., Rosenfield, K., Domanski, M. J., Lansky, A. J., McMurray, J. J. V., Tcheng, J. E., Steinhubl, S. R., Burton, P., Mauri, L., O’Connor, C. M., Pfeffer, M. A., Hung, H. M. J., Stockbridge, N. L., Chaitman, B. R., & Temple, R. J.
- Affiliations
- United States Food and Drug Administration (US)
- Stanford Medicine (US)
- Icahn School of Medicine at Mount Sinai (US)
- Cleveland Clinic (US)
- Brigham and Women's Hospital (US)
- San Francisco VA Medical Center (US)
- University Hospitals of Cleveland (US)
- Harvard University (US)
- Beth Israel Deaconess Medical Center (US)
- University of Oxford (GB)
- Ochsner Medical Center (US)
- Brooks Medtech, LLC, Reisterstown, Maryland (S.S.B.).
- Massachusetts General Hospital (US)
- Mount Sinai Hospital (CA)
- Yale University (US)
- University of Glasgow (GB)
- Duke University (US)
- Division of Digital Medicine, Scripps Translational Science Institute, La Jolla, California (S.R.S.).
- Cardiovascular and Metabolism Medical Affairs, Janssen Pharmaceuticals Inc., Titusville, New Jersey (P.B.).
- Inova Health System (US)
- Saint Louis University (US)
- ORCID
- Mahaffey, Kenneth W.
- Mehran, Roxana
- Nissen, Steven E.
- Wiviott, Stephen D.
- Dunn, Billy
- Solomon, Scott D.
- Teerlink, John R.
- Farb, Andrew
- Morrow, David A.
- Sila, Cathy A.
- Jaff, Michael R.
- Cutlip, Donald E.
- Desai, Akshay S.
- Lewis, Eldrin F.
- Gibson, C. Michael
- Landray, Martin J.
- Lincoff, A. Michael
- White, Christopher J.
- Brooks, Steven S.
- Rosenfield, Kenneth
- Lansky, Alexandra J.
- McMurray, John J.V.
- Tcheng, James E.
- Steinhubl, Steven R.
- Burton, Paul
- Mauri, Laura
- O’Connor, Christopher M.
- Pfeffer, Marc A.
- Hung, H.M. James
- Stockbridge, Norman L.
- Chaitman, Bernard R.
- Venue
- Circulation
- Published
- 2018-02-27
- Volume
- 137
- Issue
- 9
- Pages
- 961-972
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2792588444
- Cited by
- 750
- References
- 33
- Citations by year
- 2026: 89 · 2025: 114 · 2024: 99 · 2023: 87 · 2022: 104 · 2021: 119 · 2020: 76 · 2019: 47 · 2018: 13
- FWCI
- 8.79
- Type
- journal article
- Language
- en
- Open access
- green
- eprints.gla.ac.uk
- Licence
- cc-by-sa
- Locations
- Circulation (publishedVersion)
- PubMed (publishedVersion)
- Research Bank (Australian Catholic University) (submittedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion, cc-by-sa)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- cardiovascular outcomes, stroke outcome, endpoint definition, clinical trial endpoints, FDA guidance, cardiovascular safety, meta-analysis, data aggregation
- MeSH terms
- Cardiovascular Diseases, Clinical Trials as Topic, Data Collection, Humans, United States, United States Food and Drug Administration, Stroke, Endpoint Determination
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