2017 cardiovascular and stroke endpoint definitions for clinical trials

Autor: 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 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, 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, Heather D. Fitter, Kachikwu Illoh, Kenneth J. Cavanaugh, Benjamin M. Scirica, Ilan Irony, Rachel E. Brown Kichline, Jonathan G. Levine, Anna Park, Leonard Sacks, Ana Szarfman, Ellis F. Unger, Lori Ann Wachter, Bram Zuckerman, Yale Mitchel, Douglas Peddicord, Thomas Shook, Bron Kisler, Charles Jaffe, Rhonda Bartley, David L. DeMets, MariJo Mencini, Cheri Janning, Steve Bai, John Lawrence, Ralph B. D’Agostino, Stuart J. Pocock
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Cardiac Catheterization
medicine.medical_specialty
Endpoint Determination
cardiovascular and stroke endpoint definitions
endpoints
cardiovascular and stroke outcome definitions
endpoint definitions
030204 cardiovascular system & hematology
Risk Assessment
cardiovascular endpoint definitions
clinical trial endpoint definitions
03 medical and health sciences
stroke outcomes
0302 clinical medicine
Physiology (medical)
Humans
Medicine
Medical physics
Prospective Studies
030212 general & internal medicine
Clinical care
stroke endpoint definitions
Stroke
Interpretability
Heart Valve Prosthesis Implantation
Clinical Trials as Topic
Cardiovascular safety
Data collection
clinical trial endpoints
United States Food and Drug Administration
business.industry
Data Collection
cardiovascular endpoints
outcome definitions
medicine.disease
United States
cardiovascular outcomes
Hospitalization
Clinical trial
Cardiovascular Diseases
Medical product
Aggregate data
cardiovascular and stroke outcomes
business
Cardiology and Cardiovascular Medicine
stroke endpoints
030217 neurology & neurosurgery
Popis: 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.
Databáze: OpenAIRE
Externí odkaz: