TY - JOUR
T1 - The future of cardiovascular clinical research in North America and beyond - Addressing challenges and leveraging opportunities through unique academic and grassroots collaborations
AU - Roe, Matthew T.
AU - Mahaffey, Kenneth W.
AU - Ezekowitz, Justin A.
AU - Alexander, John H.
AU - Goodman, Shaun G.
AU - Hernandez, Adrian
AU - Temple, Tracy
AU - Berdan, Lisa
AU - Califf, Robert M.
AU - Harrington, Robert A.
AU - Peterson, Eric D.
AU - Armstrong, Paul W.
N1 - Funding Information:
Disclosures for Drs Roe, Alexander, Hernandez, Califf, and Peterson are available at https://dcri.org/about-us/conflict-of-interest . Dr Mahaffey's current disclosures are listed at http://med.stanford.edu/profiles/kenneth_mahaffey ; previous disclosures are listed at https://dcri.org/about-us/conflict-of-interest . Dr Ezekowitz has received consulting fees/honoraria from Servier, Abbott Labs, Pfizer, Astra-Zeneca, and Bristol-Myers Squibb and research grants from Amgen. Dr Goodman has consulted for Sanofi-Aventis, Eli Lilly, AstraZeneca, Bayer, and Bristol-Myers Squibb and has received grants from Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly, Boehringer Ingelheim, Actelion, Bayer, Merck, Daiichi Sankyo, Servier, and Pfizer. Dr Harrington has received research grants and consultant/advisory fees from Merck & Co. Dr Armstrong has received consulting fees from Eli Lilly, Hoffmann-La Roche, Regado Biosciences, Axio/Orexigen, Merck, and Bayer; grant funding from Boehringer Ingelheim, Merck, GlaxoSmithKline, Amylin, Sanofi-Aventis, and Regado; and payment for developing educational presentations from AstraZeneca. The other authors have no relationships relevant to this article to disclose.
Publisher Copyright:
© 2015 Elsevier Inc. All rights reserved.
PY - 2015/6/1
Y1 - 2015/6/1
N2 - Recent developments have highlighted the challenges facing cardiovascular clinical research in global contemporary practice, particularly in North America, including shifting priorities for drug development targets, increasing regulatory requirements, and expensive operational approaches for conducting randomized clinical trials. Nonetheless, emerging trends such as the consolidation of practices and hospitals into integrated health systems, the integration of electronic health records from thousands of practices into large data repositories to support prospective research studies, and streamlined operational approaches such as registry-based trials and risk-based monitoring have created numerous opportunities to disrupt the clinical research paradigm. Within this context, academic research organizations around the globe, particularly a strengthened collaboration of 3 established academic research organizations in North America, are uniquely positioned to promote and develop grassroots collaborations across all types of clinical practices, to delineate successful solutions to obstacles that limit clinical research initiatives, and to guide the future of cardiovascular research in the global research environment.
AB - Recent developments have highlighted the challenges facing cardiovascular clinical research in global contemporary practice, particularly in North America, including shifting priorities for drug development targets, increasing regulatory requirements, and expensive operational approaches for conducting randomized clinical trials. Nonetheless, emerging trends such as the consolidation of practices and hospitals into integrated health systems, the integration of electronic health records from thousands of practices into large data repositories to support prospective research studies, and streamlined operational approaches such as registry-based trials and risk-based monitoring have created numerous opportunities to disrupt the clinical research paradigm. Within this context, academic research organizations around the globe, particularly a strengthened collaboration of 3 established academic research organizations in North America, are uniquely positioned to promote and develop grassroots collaborations across all types of clinical practices, to delineate successful solutions to obstacles that limit clinical research initiatives, and to guide the future of cardiovascular research in the global research environment.
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U2 - 10.1016/j.ahj.2015.03.002
DO - 10.1016/j.ahj.2015.03.002
M3 - Review article
C2 - 26027610
AN - SCOPUS:84930150207
SN - 0002-8703
VL - 169
SP - 743
EP - 750
JO - American Heart Journal
JF - American Heart Journal
IS - 6
ER -