2017 cardiovascular and stroke endpoint definitions for clinical trials

Karen A. Hicks, Kenneth W. Mahaffey, Roxana Mehran, Steven Nissen, Stephen D. Wiviott, Billy Dunn, Scott D. Solomon, John R. Marler, John R. Teerlink, Andrew Farb, David A. Morrow, Shari L. Targum, Cathy A. Sila, Mary T. Thanh Hai, Michael R. Jaff, Hylton V. Joffe, Donald E. Cutlip, Akshay S. Desai, Eldrin F. Lewis, C. Michael Gibson & 18 others Martin J. Landray, A. Michael Lincoff, Christopher J. White, Steven S. Brooks, Kenneth Rosenfield, Michael J. Domanski, Alexandra J. Lansky, John J.V. McMurray, James E. Tcheng, Steven R. Steinhubl, Paul Burton, Laura Mauri, Christopher M. O'Connor, Marc A. Pfeffer, H. M.James Hung, Norman L. Stockbridge, Bernard R. Chaitman, Robert J. Temple

Research output: Contribution to journalArticle

  • 3 Citations

Abstract

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.

LanguageEnglish (US)
Pages961-972
Number of pages12
JournalCirculation
Volume137
Issue number9
DOIs
StatePublished - Jan 1 2018

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United States Food and Drug Administration
Myocardial Infarction
Clinical Trials
Marketing
Meta-Analysis
Safety
Equipment and Supplies
Pharmaceutical Preparations

Keywords

  • Cardiovascular and stroke endpoint definitions
  • Cardiovascular and stroke outcome definitions
  • Cardiovascular and stroke outcomes
  • Cardiovascular endpoint definitions
  • Cardiovascular endpoints
  • Cardiovascular outcomes
  • Clinical trial endpoint definitions
  • Clinical trial endpoints
  • Endpoint definitions
  • Endpoints
  • Outcome definitions
  • Stroke endpoint definitions
  • Stroke endpoints
  • Stroke outcomes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Hicks, K. A., Mahaffey, K. W., Mehran, R., Nissen, S., Wiviott, S. D., Dunn, B., ... Temple, R. J. (2018). 2017 cardiovascular and stroke endpoint definitions for clinical trials. Circulation, 137(9), 961-972. https://doi.org/10.1161/CIRCULATIONAHA.117.033502

2017 cardiovascular and stroke endpoint definitions for clinical trials. / Hicks, Karen A.; Mahaffey, Kenneth W.; Mehran, Roxana; Nissen, Steven; Wiviott, Stephen D.; Dunn, Billy; Solomon, Scott D.; Marler, John R.; Teerlink, John R.; Farb, Andrew; Morrow, David A.; Targum, Shari L.; Sila, Cathy A.; Thanh Hai, Mary T.; Jaff, Michael R.; Joffe, Hylton V.; 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; Domanski, Michael J.; 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.; Temple, Robert J.

In: Circulation, Vol. 137, No. 9, 01.01.2018, p. 961-972.

Research output: Contribution to journalArticle

Hicks, KA, Mahaffey, KW, Mehran, R, Nissen, S, Wiviott, SD, Dunn, B, Solomon, SD, Marler, JR, Teerlink, JR, Farb, A, Morrow, DA, Targum, SL, Sila, CA, Thanh Hai, MT, Jaff, MR, Joffe, HV, Cutlip, DE, Desai, AS, Lewis, EF, Gibson, CM, Landray, MJ, Lincoff, AM, White, CJ, Brooks, SS, Rosenfield, K, Domanski, MJ, Lansky, AJ, McMurray, JJV, Tcheng, JE, Steinhubl, SR, Burton, P, Mauri, L, O'Connor, CM, Pfeffer, MA, Hung, HMJ, Stockbridge, NL, Chaitman, BR & Temple, RJ 2018, '2017 cardiovascular and stroke endpoint definitions for clinical trials' Circulation, vol. 137, no. 9, pp. 961-972. https://doi.org/10.1161/CIRCULATIONAHA.117.033502
Hicks, Karen A. ; Mahaffey, Kenneth W. ; Mehran, Roxana ; Nissen, Steven ; Wiviott, Stephen D. ; Dunn, Billy ; Solomon, Scott D. ; Marler, John R. ; Teerlink, John R. ; Farb, Andrew ; Morrow, David A. ; Targum, Shari L. ; Sila, Cathy A. ; Thanh Hai, Mary T. ; Jaff, Michael R. ; Joffe, Hylton V. ; 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 ; Domanski, Michael J. ; 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. ; Temple, Robert J. / 2017 cardiovascular and stroke endpoint definitions for clinical trials. In: Circulation. 2018 ; Vol. 137, No. 9. pp. 961-972.
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