Ken Mahaffey

Kenneth W. Mahaffey, MD, Professor and Vice Chair of Clinical Research, Department of Medicine, Stanford University School of Medicine; Director, Stanford Center for Clinical Research (SCCR)


Research Description: Prior to joining Stanford in 2013, Dr. Mahaffey was at Duke University for 20 years. He leads the design and conduct of multicenter clinical trials and analyses of important clinical cardiac issues using large patient databases.  His focus is testing novel anticoagulants and antiplatelet agents for treating acute coronary syndromes (ACS) and atrial fibrillation (AF), the cardiovascular safety and efficacy of treat diabetes and identifying innovative approaches to improve the efficiency and quality of clinical research methods and procedures.  These efforts have resulted in the approval of new therapies for the treatment of patients with ACS or AF and defined the current standard approaches for the ascertainment and adjudication of clinical endpoints. I have lead or served on the Executive Committees for many cardiovascular outcome trials, over 125 Clinical Endpoint Committees, and multiple Data Safety Monitoring Boards.  At DCRI, I was also the faculty leader of the Clinical Events Classification (CEC and Cardiovascular MegaTrial groups that were both internationally recognized as a leaders in the field and developed efficient strategies to adjudicate clinical endpoints and conduct and manage operational features of global cardiovascular clinical trials.  He has worked with the FDA and is a consultant for the Endocrinologic and Metabolic Drugs Advisory Committee.  Dr. Mahaffey is the on the executive committee of the CANVAS and CANVAS R trials and is the co-Principal Investigator and co-chair of the Clinical Events Committee for CREDENCE.  These three trials will enroll nearly 15,000 patients to evaluate the effects of canagliflozin on renal and cardiovascular outcomes in subjects with type 2 diabetes mellitus and diabetic nephropathy. 


Selected relevant publications (Stanford DRC members in BOLD):

  1. Frederich R, Alexander JH, Fiedorek FT, Donovan M, Berglind N, Harris S, Chen R, Wolf R, Mahaffey KW.  A systematic assessment of cardiovascular outcomes in the saxagliptin drug development program for Type 2 diabetes.  Postgrad Med 2010;122(3):16-27.
  2. Neal B, Perkovic V, de Zeeuw D, Mahaffey KW,…Matthews D. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial. Am Heart J. 2013 Aug;166(2):217-223.e11.
  3. Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, Mahaffey KW, Mathieu C, Woo V, Wysham C, Capuano G, Desai M, Shaw W, Vercruysse F, Meininger G, Neal B; CANVAS trial collaborative group. Efficacy and safety of canagliflozin when used in conjunction with incretin-mimetic therapy in patients with type 2 diabetes.  Diabetes Obes Metab 2016;18(1):82-91.
  4. Neal B, Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Ways K, Desai M,..; CANVAS Trial Collaborative Group. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care 38:403-11, 2015.
  5. Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, Mahaffey KW,…Desai M, Shaw W, Vercruysse F, Meininger G, Neal B. Efficacy and Safety of Canagliflozin Used in Conjunction with Sulfonylurea in Patients with Type 2 Diabetes Mellitus: A Randomized, Controlled Trial.  Diabetes Ther 6(3):289-302, 2015.