Improving cardiovascular clinical trials conduct in the United States: recommendation from clinicians, researchers, sponsors, and regulators.
Advances in medical therapies leading to improved patient outcomes are in large part related to successful conduct of clinical trials that offer critical information regarding the efficacy and safety of novel interventions. The conduct of clinical trials in the United States, however, continues to face increasing challenges with recruitment and retention. These trends are paralleled by an increasing shift toward more multinational trials where most participants are enrolled in countries outside the United States, bringing into question the generalizability of the results to the American population. This manuscript presents the perspectives and recommendations from clinicians, researchers, sponsors, and regulators who attended a meeting facilitated by the Food and Drug Administration to improve upon the current clinical trial trends in the United States.
Cardiology Division, Stony Brook University, Stony Brook, NY. Electronic address: javed.butler@stonybrookmedicine.edu.
Javed
J
Butler
University of California, Los Angeles, CA.
Gregg C
GC
Fonarow
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Christopher
C
O'Connor
University of North Carolina, Chapel Hill, NC.
Kirkwood
K
Adams
Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL.
Robert O
RO
Bonow
Cardiovascular & Metabolism, Janssen Pharmaceuticals, Raritan, NJ.
Robert J
RJ
Cody
Vanderbilt University, Nashville, TN.
Sean P
SP
Collins
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Preston
P
Dunnmon
Department of Cardiology, Witten University, Witten, Germany; Global Drug Discovery, Clinical Sciences, Bayer Pharma AG, Berlin, Germany.
Wilfried
W
Dinh
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Mona
M
Fiuzat
Emory Cardiovascular Clinical Research Institute, Emory University, Atlanta, GA.
Vasiliki V
VV
Georgiopoulou
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Stephen
S
Grant
Global Clinical Development, Bayer HealthCare AG, Wuppertal, Germany.
So-Young
SY
Kim
Takeda Pharmaceuticals International, Deerfield IL.
Stuart
S
Kupfer
Novartis Pharmaceuticals Inc., East Hanover, NJ.
Martin
M
Lefkowitz
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC.
Robert J
RJ
Mentz
Global Clinical Development, Bayer HealthCare AG, Wuppertal, Germany.
Frank
F
Misselwitz
Division of Cardiology, University of Michigan School of Medicine, Ann Arbor, MI.
Bertram
B
Pitt
Global Clinical Development, Bayer HealthCare AG, Wuppertal, Germany.
Lothar
L
Roessig
University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, PA.
Erik
E
Schelbert
Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD.
Monica
M
Shah
Cardiovascular Division, Brigham and Women's Hospital, Boston, MA.
Scott
S
Solomon
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Norman
N
Stockbridge
Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Clyde
C
Yancy
Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL.
Mihai
M
Gheorghiade
D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D006333:Heart Failure; D006801:Humans; D010560:Personnel Selection; D017410:Practice Guidelines as Topic; D014481:United States