Open Access2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Author(s) -
Karen A. Hicks,
Kenneth W. Mahaffey,
Roxana Mehran,
Steven E. Nissen,
Stephen D. Wiviott,
Billy Dunn,
Scott D. Solomon,
John R. Marler,
John R. Teerlink,
Andrew Farb,
David A. Morrow,
Shari Targum,
Cathy Sila,
Mary T. Thanh Hai,
Michael R. Jaff,
Hylton V. Joffe,
Donald E. Cutlip,
Akshay S. Desai,
Eldrin F. Lewis,
C. Michael Gibson,
Martin Landray,
A. Michael Lincoff,
Christopher J. White,
Steven S. Brooks,
Kenneth Rosenfield,
Michaël 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,
Hung Hung,
Norman Stockbridge,
Bernard R. Chaitman,
Robert J. Temple
Publication year - 2018
Publication title -
circulation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 7.795
H-Index - 607
eISSN - 1524-4539
pISSN - 0009-7322
DOI - 10.1161/circulationaha.117.033502
Subject(s) - medicine , clinical trial , data collection , food and drug administration , interpretability , alternative medicine , stroke (engine) , clinical study design , clinical research , aggregate data , research design , medline , medical physics , intensive care medicine , risk analysis (engineering) , pathology , artificial intelligence , computer science , mechanical engineering , social science , statistics , mathematics , sociology , law , political science , engineering
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.
Accelerating Research
Robert Robinson Avenue,
Oxford Science Park, Oxford
OX4 4GP, United Kingdom
Address
John Eccles HouseRobert Robinson Avenue,
Oxford Science Park, Oxford
OX4 4GP, United Kingdom