OBJECTIVES: The aim of this study was to describe international enrollment and participation in National Institutes of Health (NIH)-sponsored cardiovascular randomized controlled trials (RCTs). BACKGROUND: RCTs provide the evidence base for major societal guidelines and profoundly influence patient care in the United States. Increased international involvement in clinical trials has been observed, but the rate of international enrollment in NIH-sponsored cardiovascular RCTs has not been described. METHODS: The NIH registry of clinical trials was searched for phase III or IV cardiovascular RCTs funded by the National Heart, Lung, and Blood Institute. Studies with outcomes of myocardial infarction, stroke, or death published between 1997 and 2009 were included. Rates of international enrollment were obtained from published data or personal communication with corresponding authors. RESULTS: Twenty-four studies met all inclusion criteria. Nineteen trials including 151,682 patients had international participation (IP), with median IP of 9.5% (range 0% to 100%). Coronary artery disease trials (11 studies) had nearly 50% international enrollment. High-risk trials and trials testing acute interventions tended to have higher rates of IP. CONCLUSIONS: Cardiovascular RCTs sponsored by the National Heart, Lung, and Blood Institute have substantial rates of international enrollment, particularly coronary artery disease trials. Given questions of applicability and ethical and financial considerations, IP in U.S. clinical trials deserves further scrutiny.
OBJECTIVES: The aim of this study was to describe international enrollment and participation in National Institutes of Health (NIH)-sponsored cardiovascular randomized controlled trials (RCTs). BACKGROUND: RCTs provide the evidence base for major societal guidelines and profoundly influence patient care in the United States. Increased international involvement in clinical trials has been observed, but the rate of international enrollment in NIH-sponsored cardiovascular RCTs has not been described. METHODS: The NIH registry of clinical trials was searched for phase III or IV cardiovascular RCTs funded by the National Heart, Lung, and Blood Institute. Studies with outcomes of myocardial infarction, stroke, or death published between 1997 and 2009 were included. Rates of international enrollment were obtained from published data or personal communication with corresponding authors. RESULTS: Twenty-four studies met all inclusion criteria. Nineteen trials including 151,682 patients had international participation (IP), with median IP of 9.5% (range 0% to 100%). Coronary artery disease trials (11 studies) had nearly 50% international enrollment. High-risk trials and trials testing acute interventions tended to have higher rates of IP. CONCLUSIONS: Cardiovascular RCTs sponsored by the National Heart, Lung, and Blood Institute have substantial rates of international enrollment, particularly coronary artery disease trials. Given questions of applicability and ethical and financial considerations, IP in U.S. clinical trials deserves further scrutiny.
Authors: Stephen J Greene; Adrian F Hernandez; Jie-Lena Sun; Javed Butler; Paul W Armstrong; Justin A Ezekowitz; Faiez Zannad; João Pedro Ferreira; Adrian Coles; Marco Metra; Adriaan A Voors; Robert M Califf; Christopher M O'Connor; Robert J Mentz Journal: Circ Cardiovasc Qual Outcomes Date: 2018-10
Authors: Valentin Fuster; Deepak L Bhatt; Robert M Califf; Alan D Michelson; Marc S Sabatine; Dominick J Angiolillo; Eric R Bates; David J Cohen; Barry S Coller; Bruce Furie; Jean-Sebastien Hulot; Kenneth G Mann; Jessica L Mega; Kiran Musunuru; Christopher J O'Donnell; Matthew J Price; David J Schneider; Daniel I Simon; Jeffrey I Weitz; Marlene S Williams; W Keith Hoots; Yves D Rosenberg; Ahmed A K Hasan Journal: Circulation Date: 2012-09-25 Impact factor: 29.690
Authors: H Vernon Anderson; William S Weintraub; Martha J Radford; Mark S Kremers; Matthew T Roe; Richard E Shaw; Dana M Pinchotti; James E Tcheng Journal: J Am Coll Cardiol Date: 2013-03-06 Impact factor: 24.094
Authors: Elizabeth O Ofili; Laura E Schanberg; Barbara Hutchinson; Felix Sogade; Icilma Fergus; Phillip Duncan; Joe Hargrove; Andre Artis; Osita Onyekwere; Wayne Batchelor; Marcus Williams; Adefisayo Oduwole; Anekwe Onwuanyi; Folake Ojutalayo; Jo Ann Cross; Todd B Seto; Henry Okafor; Priscilla Pemu; Lilly Immergluck; Marilyn Foreman; Ernest Alema Mensah; Alexander Quarshie; Mohamed Mubasher; Almelida Baker; Alnida Ngare; Andrew Dent; Mohamad Malouhi; Paul Tchounwou; Jae Lee; Traci Hayes; Muna Abdelrahim; Daniel Sarpong; Emma Fernandez-Repollet; Stephen O Sodeke; Adrian Hernandez; Kevin Thomas; Anne Dennos; David Smith; David Gbadebo; Janet Ajuluchikwu; B Waine Kong; Cassandra McCollough; Sarah R Weiler; Marc D Natter; Kenneth D Mandl; Shawn Murphy Journal: Int J Environ Res Public Health Date: 2019-05-10 Impact factor: 3.390