Multicenter Cardiovascular Studies and Trials: Lessons Learned From 35 Years of Productive Collaboration

• Published in: Journal of the American College of Cardiology Vol. 68; no. 20; pp. 2232 - 2234
• Main Authors: Moss, Arthur J., Benhorin, Jesia, Bigger, Thomas, Block-Thomsen, Poul Eric, Bodenheimer, Monty, Brown, Mary, Case, Robert, Dwyer, Edward M., Eberly, Shirley, Fleiss, Joseph, Francis, Charles, Gillespie, John, Goldstein, Robert, Greenberg, Henry, Haigney, Mark, Klein, Helmut, Krone, Ronald, Kutyifa, Valentina, Lichstein, Edgar, Locati, Emanuela, Marcus, Frank, Oakes, David, Odoroff, Charles, Ryan, Daniel, Zareba, Wojciech, Beck, Christopher, Cannom, David, Daubert, James, Estes, Mark, Goldenberg, Ilan, Hall, Jack, Hammes, Stephen, Huang, David, Knops, Reinoud, Kosiborod, Michael, Poole, Jeanne, Schuger, Claudio, Singh, Jagmeet, Solomon, Scott, Wilber, David
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 15-11-2016; Elsevier Limited
• Subjects: Cardiology; Cardiology - organization & administration; Cardiology - standards; Clinical trials; Collaboration; Liability insurance; Mortality; Multicenter Studies as Topic; Patient safety; Randomized Controlled Trials as Topic; Studies; United States > US
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2016.09.930

For a study to be considered "positive" in terms of providing evidence to assist in securing approval of a new treatment by the U.S. Food and Drug Administration, convincing evidence of effectiveness requires a 2-sided alpha p value <=0.05, or equivalently that a 95% confidence interval for the true parameter value being estimated (treatment difference, risk difference, or hazard ratio) not include the null value of the parameter. The data safety monitoring board (DSMB) was responsible for the safety of study subjects and for the efficacy of study procedures, including the timely and reliable acquisition and management of study information. [...]the DSMB protected the interests of trial participants but also the interests of the sponsor and the larger community in ensuring a scientifically valid outcome.