Selected IDMC Publications

Selected IDMC Publications

IDMC Process, Design, and Benefit

Sartor O, Halabi S.  Independent data monitoring committees: An update and overview.  Urologic Oncology: Seminars and Original Investigations. 2015;33(3):143-148.

Hess C, Roe M, Gibson C, Temple R, Pencina M, Zarin D, Anstrom K, Alexander J, Sherman R, Fiedorek F, Mahaffey K, Lee K, Chow S, Armstrong P, Califf R. Independent data monitoring committees: Preparing a path for the future. American Heart Journal. 2014;168(2):135-141.

Armstrong P, Califf R. Data and Safety Monitoring Boards: Academic Credit Where Credit Is Due? JAMA. 2013;310(15):1563-1564.

Chow S, Corey R, Lin M. On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials. Journal of Biopharmaceutical Statistics. 2012;22(4):853-867.

DeMets D, Califf R, Dixon D, Ellenberg S, Fleming T, Held P, Julian D, Kaplan R, Levine R, Neaton J, Packer M, Pocock S, Rockhold F, Seto B, Siegel J, Snapinn S, Stump D, Temple R, Whitley R.. Issues in regulatory guidelines for data monitoring committees Clin Trials April 2004;1:162-169.

Califf R, Lee K.  Data and safety monitoring committees:  Philosophy and practice. American Heart Journal. 2001;141:154-155.

 

Recent trials with DMC support by DCRI 

G. Ralph Corey, M.D., Heidi Kabler, M.D., Purvi Mehra, M.D., Sandeep Gupta, M.D., J. Scott Overcash, M.D., Ashwin Porwal, et al for the SOLO I Investigators. Single-Dose Oritavancin in the Treatment of Acute Bacterial Skin Infections. N Engl J Med 2014; 370:2180-2190.

Newman MF, Ferguson TB, White JA, Ambrosio G, Koglin J, Nussmeier NA, et al for RED-CABG Steering Committee and Investigators. Effect of adenosine-regulating agent acadesine on morbidity and mortality associated with coronary artery bypass grafting: the RED-CABG randomized controlled trial. JAMA 2012; 308(2):157-64.

Alexander, JH, Lopes, RD, James, S, Kilaru, R, He, Y, Mohan, P, Bhatt, DL, et al for APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med 2011; 365: 699-708.

Eric J. Velazquez, M.D., Kerry L. Lee, Ph.D., Marek A. Deja, M.D., Ph.D., Anil Jain, M.D., George Sopko, M.D., M.P.H., Andrey Marchenko, M.D. et al for the STICH Investigators. Coronary-Artery Bypass Surgery in Patients with Left Ventricular Dysfunction. N Engl J Med 2011; 364:1607-1616.