TY - JOUR
T1 - Rescuing clinical trials in the united states and beyond:A call for action
AU - Eapen, Zubin J.
AU - Vavalle, John P.
AU - Granger, Christopher B.
AU - Harrington, Robert A.
AU - Peterson, Eric D.
AU - Califf, Robert M.
N1 - Funding Information:
Drs Eapen and Vavalle have no relevant conflicts to report. Dr Granger reports research funding from Boehringer Ingelheim, Bristol-Myers-Squibb, GlaxoSmithKline, Medtronic Foundation, Merck & Co, Pfizer, Sanofi-Aventis, Takeda, and The Medicines Company (all significant); consulting or other services (including CME) from Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Hoffmann-La Roche, Sanofi-Aventis, Takeda, The Medicines Company, and AstraZeneca (all modest); and consulting or other non-CME services from Boehringer Ingelheim, Lilly, Pfizer, Sanofi-Aventis (all modest), and Bristol-Myers Squibb (significant). Dr Harrington reports research funding from Abott Laboratories, Abiomed, Acm Cardiovascular, and Aastrom Biosciences (all significant). Dr Peterson reports research funding from Eli Lilly & Company, Ortho-McNeil-Janssen Pharmaceuticals, Inc; Society of Thoracic Surgeons; American Heart Association; and American College of Cardiology (all significant). He also reports consulting or other services (including CME) from AstraZeneca; Boehringer Ingelheim; Genentech; Johnson & Johnson; Ortho-McNeil-Janssen Pharmaceuticals, Inc; Pfizer; Sanofi-Aventis; and WebMD (all modest). Dr Califf reports research funding from Bristol-Myers Squibb Foundation, and Novartis (both significant) and consulting or other services (include CME or other non-CME) from Bayer, Bristol-Myers Squibb Foundation, CV Sight, LLC, DSI-Lilly, Gambro, Heart.org, Janssen R&D, LLC, Kowa, and Novartis (all modest).
Funding Information:
This white paper summarizes the proceedings of a think tank meeting partially supported by the following companies: AstraZeneca LP, Bristol-Myers Squibb, Eli Lilly and Company, F. Hoffmannn-La Roche Ltd, GlaxoSmithKline, Portola Pharmaceuticals, Inc., Sanofi U.S., St. Jude Medical, The Medicines Company.
PY - 2013/6
Y1 - 2013/6
N2 - Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems. (Am Heart J 2013;165:837-47.).
AB - Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems. (Am Heart J 2013;165:837-47.).
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UR - http://www.scopus.com/inward/citedby.url?scp=84880081205&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2013.02.003
DO - 10.1016/j.ahj.2013.02.003
M3 - Article
C2 - 23708153
AN - SCOPUS:84880081205
SN - 0002-8703
VL - 165
SP - 837
EP - 847
JO - American heart journal
JF - American heart journal
IS - 6
ER -