Maximizing scientific knowledge from randomized clinical trials

TY - JOUR

T1 - Maximizing scientific knowledge from randomized clinical trials

AU - Gustafsson, Finn

AU - Atar, Dan

AU - Pitt, Bertram

AU - Zannad, Faiez

AU - Pfeffer, Marc A

AU - participants in 10th Cardiovascular Clinical Trialists Workshop

N1 - Copyright 2010 Mosby, Inc. All rights reserved.

PY - 2010/6/1

Y1 - 2010/6/1

N2 - Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists is outlined.

AB - Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists is outlined.

U2 - 10.1016/j.ahj.2010.03.002

DO - 10.1016/j.ahj.2010.03.002

M3 - Journal article

SN - 0002-8703

VL - 159

SP - 937

EP - 943

JO - American Heart Journal

JF - American Heart Journal

IS - 6

ER -