Scholars@Duke

• Background
• 

  Education, Training, & Certifications

  • M.D., University of North Carolina at Chapel Hill 1977
  • M.S., University of North Carolina at Chapel Hill 1972
  • B.S., University of North Carolina at Chapel Hill 1970
• 

  Duke Appointment History

  • Professor of Medicine, Medicine, General Internal Medicine, Medicine 2012 - 2014
  • Associate Professor of Medicine, Medicine, General Internal Medicine, Medicine 2011 - 2012
  • Associate Professor of Medicine, Medicine, General Internal Medicine, Medicine 2006 - 2011
  • Assistant Clinical Professor of Medicine, Medicine, General Internal Medicine, Medicine 1998 - 2006
  • Instructor, Temporary in the Department of Medicine, Medicine, General Internal Medicine, Medicine 1997 - 1998
• Recognition
• 

  In the News

  • MAY 27, 2016

    The Washington Post

    FDA approves new way to treat opioid addiction -- under the skin

  • JAN 14, 2016

    USA Today

    Dr. Judith Kramer comments: Panel recommends FDA approve implant to treat opiate addiction
• Research
• 

  Selected Grants

  • CTTI U19 awarded by Food and Drug Administration 2009 - 2015
  • Duke Cardiovascular CERTs awarded by Agency for Healthcare Research and Quality 2007 - 2012
  • Barriers to Optimal Cardiovascular Medication Use in Diabetes and Renal Disease awarded by National Institutes of Health 2006 - 2011
  • DCRI Research Center for CERTs awarded by Agency for Healthcare Research and Quality 1999 - 2008
  • CBER Study of Adverse Effects in use of TNF Inhibitors awarded by Food and Drug Administration 2004 - 2007
  • Managing the Risks of Therapeutic Products awarded by Agency for Healthcare Research and Quality 2003 - 2004
  • Managing the Risks of Therapeutic Products, January 12-14, 2003. awarded by Agency for Healthcare Research and Quality 2002 - 2003
  • Coordinating Center for CERTs awarded by National Institutes of Health 2002 - 2003
  • DCRI CERT for Cardiovascular Therapies awarded by National Institutes of Health 1999 - 2002
• Publications & Artistic Works
• 

  Selected Publications

  • Conference Papers

    • Curtis, LH, Hammill, BG, Eisenstein, EL, Kramer, JM, and Anstrom, KJ. "Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases." October 2007.  Full Text  Link to Item
    • Curtis, JR, Saag, KG, Martin, C, Patkar, N, Shatin, D, Kramer, JM, and Braun, MM. "Validation of claims-identified serious adverse events in rheumatoid arthritis and Crohn's disease patients." December 2005.  Link to Item
    • Kramer, JM, Chen, AY, Hammill, BG, DeLong, ER, LaPointe, NA, Muhlbaier, LH, McCants, CB, and Califf, RM. "Time trends and factors associated with outpatient beta-blocker use in patients with heart failure or left ventricular dysfunction." May 25, 2004.  Link to Item
    • Kramer, JM, Fetterolf, D, Charde, JP, Snyder, R, Hammill, B, DeLong, E, Hoffman, BS, Arrington, RL, LaPointe, NA, and Peterson, ED. "National evaluation of adherence to beta-blocker therapy for one year after acute myocardial infarction in patients with commercial health insurance." May 25, 2004.  Link to Item
    • Newby, LK, LaPointe, NMA, Kramer, JM, Chen, A, Hammil, BG, Muhlbaier, LH, DeLong, ER, and Califf, RM. "Long-term adherence to evidence-based secondary prevention in coronary artery disease." May 25, 2004.  Link to Item
    • LaPointe, NMA, Kramer, JM, DeLong, ER, Muhlbaier, LH, Chen, A, Hammill, BG, McCants, CB, and Califf, RM. "A randomized controlled trial of Internet-based academic detailing in heart failure: Failure to engage or change." March 3, 2004.  Link to Item

  • Journal Articles

    • Sethi, SS, Kramer, JM, Gagnon, S, Nadzan, G, and Vega, JM. "Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND." Therapeutic Innovation & Regulatory Science 48, no. 6 (November 2014): 741-748.  Full Text
    • Kramer, JM, Vock, D, Greenberg, HE, Janning, C, Szczech, L, Salgo, M, Gagnon, S, and Ellenberg, S. "Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule." Therapeutic innovation & regulatory science 48, no. 4 (July 2014): 413-419.  Full Text
    • Archdeacon, P, Grandinetti, C, Vega, JM, Balderson, D, and Kramer, JM. "Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application." Therapeutic Innovation & Regulatory Science 48, no. 2 (March 2014): 200-207.  Full Text
    • Alexander, KP, Kong, DF, Starr, AZ, Kramer, J, Chiswell, K, Tasneem, A, and Califf, RM. "Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov. (Published online)" J Am Heart Assoc 2, no. 5 (September 26, 2013): e000009-.  Full Text  Link to Item
    • Check, DK, Weinfurt, KP, Dombeck, CB, Kramer, JM, and Flynn, KE. "Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature." Clin Trials 10, no. 4 (August 2013): 560-567. (Review)  Full Text  Link to Item
    • Flynn, KE, Kramer, JM, Dombeck, CB, and Weinfurt, KP. "Participants' perspectives on safety monitoring in clinical trials." Clin Trials 10, no. 4 (August 2013): 552-559.  Full Text  Link to Item
    • Flynn, KE, Hahn, CL, Kramer, JM, Check, DK, Dombeck, CB, Bang, S, Perlmutter, J, Khin-Maung-Gyi, FA, and Weinfurt, KP. "Using central IRBs for multicenter clinical trials in the United States." PLoS One 8, no. 1 (2013): e54999-.  Full Text  Link to Item
    • Landray, MJ, Grandinetti, C, Kramer, JM, Morrison, BW, Ball, L, and Sherman, RE. "Clinical Trials: Rethinking How We Ensure Quality." DRUG INFORMATION JOURNAL 46, no. 6 (November 2012): 657-660.  Full Text  Link to Item
    • Califf, RM, Zarin, DA, Kramer, JM, Sherman, RE, Aberle, LH, and Tasneem, A. "Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010." JAMA 307, no. 17 (May 2, 2012): 1838-1847.  Full Text  Link to Item
    • Calvert, SB, Kramer, JM, Anstrom, KJ, Kaltenbach, LA, Stafford, JA, and Allen LaPointe, NM. "Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial." Am Heart J 163, no. 4 (April 2012): 657-65.e1.  Full Text  Link to Item
    • Kramer, JM, Smith, PB, and Califf, RM. "Impediments to clinical research in the United States." Clin Pharmacol Ther 91, no. 3 (March 2012): 535-541.  Full Text  Link to Item
    • Velentgas, P, Amato, AA, Bohn, RL, Chan, KA, Cochrane, T, Funch, DP, Dashevsky, I, Duddy, AL, Gladowski, P, Greenberg, SA, Kramer, JM, McMahill-Walraven, C, Nakasato, C, Spettell, CM, Syat, BL, Wahl, PM, Walker, AM, Zhang, F, Brown, JS, and Platt, R. "Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination." Pharmacoepidemiology and Drug Safety 21, no. 12 (2012): 1350-1358.  Full Text
    • Morrison, BW, Cochran, CJ, White, JG, Harley, J, Kleppinger, CF, Liu, A, Mitchel, JT, Nickerson, DF, Zacharias, CR, Kramer, JM, and Neaton, JD. "Monitoring the quality of conduct of clinical trials: A survey of current practices." Clinical Trials 8, no. 3 (2011): 342-349.  Full Text
    • Kramer, JM. "Long-Acting Beta-Agonists in Asthma REPLY." NEW ENGLAND JOURNAL OF MEDICINE 361, no. 2 (July 9, 2009): 209-209.  Link to Item
    • Allen LaPointe, NM, Zhou, Y, Stafford, JA, Hernandez, AF, Kramer, JM, and Anstrom, KJ. "Association between mortality and persistent use of beta blockers and angiotensin-converting enzyme inhibitors in patients with left ventricular systolic dysfunction and coronary artery disease." Am J Cardiol 103, no. 11 (June 1, 2009): 1518-1524.  Full Text  Link to Item
    • Kramer, JM. "Balancing the benefits and risks of inhaled long-acting beta-agonists--the influence of values." N Engl J Med 360, no. 16 (April 16, 2009): 1592-1595.  Full Text  Link to Item
    • Tricoci, P, Allen, JM, Kramer, JM, Califf, RM, and Smith, SC. "Scientific evidence underlying the ACC/AHA clinical practice guidelines." JAMA 301, no. 8 (February 25, 2009): 831-841.  Full Text  Link to Item
    • Kramer, JM, Curtis, LH, Dupree, CS, Hernandez, AF, Massing, M, and Anstrom, KJ. "Eligibility criteria for β-blockade might have to be taken into account - Reply." Archives of Internal Medicine 169, no. 11 (2009): 1078--.
    • Kramer, JM. "The author replies." New England Journal of Medicine 361, no. 2 (2009): 209--.  Full Text
    • Luce, BR, Kramer, JM, Goodman, SN, Connor, JT, Tunis, S, Whicher, D, and Schwartz, JS. "Rethinking randomized clinical trials for comparative effectiveness research: The need for transformational change." Annals of Internal Medicine 151, no. 3 (2009): 206-209.
    • Curtis, LH, Greiner, MA, Hammill, BG, Kramer, JM, Whellan, DJ, Schulman, KA, and Hernandez, AF. "Early and long-term outcomes of heart failure in elderly persons, 2001-2005." Arch Intern Med 168, no. 22 (December 8, 2008): 2481-2488.  Full Text  Link to Item
    • Kramer, JM, Curtis, LH, Dupree, CS, Pelter, D, Hernandez, A, Massing, M, and Anstrom, KJ. "Comparative effectiveness of beta-blockers in elderly patients with heart failure." Arch Intern Med 168, no. 22 (December 8, 2008): 2422-2428.  Full Text  Link to Item
    • Anstrom, KJ, Kong, DF, Shaw, LK, Califf, RM, Kramer, JM, Peterson, ED, Rao, SV, Matchar, DB, Mark, DB, Harrington, RA, and Eisenstein, EL. "Long-term clinical outcomes following coronary stenting." Arch Intern Med 168, no. 15 (August 11, 2008): 1647-1655.  Full Text  Link to Item
    • Califf, RM, and Kramer, JM. "The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment." Pharmacoepidemiol Drug Saf 17, no. 8 (August 2008): 782-786.  Full Text  Link to Item
    • Rao, SV, Califf, RM, Kramer, JM, Peterson, ED, Gross, TP, Pepine, CJ, Williams, DO, Donohoe, D, Waksman, R, Mehran, R, and Krucoff, MW. "Postmarket evaluation of breakthrough technologies." Am Heart J 156, no. 2 (August 2008): 201-208.  Full Text  Link to Item
    • Smith, DH, Kramer, JM, Perrin, N, Platt, R, Roblin, DW, Lane, K, Goodman, M, Nelson, WW, Yang, X, and Soumerai, SB. "A randomized trial of direct-to-patient communication to enhance adherence to β-blocker therapy following myocardial infarction." Archives of Internal Medicine 168, no. 5 (2008): 477-483.  Full Text
    • Velentgas, P, Bohn, RL, Brown, JS, Chan, KA, Gladowski, P, Holick, CN, Kramer, JM, Nakasato, C, Spettell, CM, Walker, AM, Zhang, F, and Platt, R. "A distributed research network model for post-marketing safety studies: The Meningococcal Vaccine Study." Pharmacoepidemiology and Drug Safety 17, no. 12 (2008): 1226-1234.  Full Text
    • Curtis, LH, Hammill, BG, Eisenstein, EL, Kramer, JM, and Anstrom, KJ. "Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases." Med Care 45, no. 10 Supl 2 (October 2007): S103-S107.  Full Text  Link to Item
    • Eisenstein, EL, Anstrom, KJ, Kong, DF, Shaw, LK, Tuttle, RH, Mark, DB, Kramer, JM, Harrington, RA, Matchar, DB, Kandzari, DE, Peterson, ED, Schulman, KA, and Califf, RM. "Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation." JAMA 297, no. 2 (January 10, 2007): 159-168.  Full Text  Link to Item
    • Curtis, JR, Kramer, JM, Martin, C, Saag, KG, Patkar, N, Shatin, D, Burgess, M, Xie, A, and Braun, MM. "Heart failure among younger rheumatoid arthritis and Crohn's patients exposed to TNF-α antagonists." Rheumatology 46, no. 11 (2007): 1688-1693.  Full Text
    • Curtis, JR, Martin, C, Saag, KG, Patkar, NM, Kramer, J, Shatin, D, Allison, J, and Braun, MM. "Confirmation of administrative claims-identified opportunistic infections and other serious potential adverse events associated with tumor necrosis factor alpha antagonists and disease-modifying antirheumatic drugs." Arthritis and rheumatism 57, no. 2 (2007): 343-346.  Full Text
    • Curtis, JR, Martin, C, Saag, KG, Patkar, NM, Kramer, J, Shatin, D, Allison, J, and Braun, MM. "Confirmation of administrative claims-identified opportunistic infections and other serious potential adverse events associated with tumor necrosis factor α antagonists and disease-modifying antirheumatic drugs." Arthritis Care and Research 57, no. 2 (2007): 343-346.  Full Text
    • Curtis, LH, Hammill, BG, Eisenstein, EL, Kramer, JM, and Anstrom, KJ. "Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases." Medical Care 45, no. 10 SUPPL. 2 (2007): S103-S107.
    • Kramer, JM, Hammill, B, Anstrom, KJ, Fetterolf, D, Snyder, R, Charde, JP, Hoffman, BS, Allen LaPointe, N, and Peterson, E. "National evaluation of adherence to beta-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance." Am Heart J 152, no. 3 (September 2006): 454.e1-454.e8.  Full Text  Link to Item
    • Allen LaPointe, NM, Curtis, LH, Chan, KA, Kramer, JM, Lafata, JE, Gurwitz, JH, Raebel, MA, and Platt, R. "Frequency of high-risk use of QT-prolonging medications." Pharmacoepidemiol Drug Saf 15, no. 6 (June 2006): 361-368.  Full Text  Link to Item
    • LaPointe, NMA, DeLong, ER, Chen, A, Hammill, BG, Muhlbaier, LH, Califf, RM, and Kramer, JM. "Multifaceted intervention to promote beta-blocker use in heart failure." Am Heart J 151, no. 5 (May 2006): 992-998.  Full Text  Link to Item
    • Ridley, DB, Kramer, JM, Tilson, HH, Grabowski, HG, and Schulman, KA. "Spending on postapproval drug safety." Health Aff (Millwood) 25, no. 2 (March 2006): 429-436.  Full Text  Open Access Copy  Link to Item
    • Newby, LK, LaPointe, NMA, Chen, AY, Kramer, JM, Hammill, BG, DeLong, ER, Muhlbaier, LH, and Califf, RM. "Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease." Circulation 113, no. 2 (January 17, 2006): 203-212.  Full Text  Link to Item
    • LaPointe, NMA, DeLong, ER, Chen, A, Hammill, BG, Muhlbaier, LH, Califf, RM, and Kramer, JM. "Multifaceted intervention to promote β-blocker use in heart failure." American Heart Journal 151, no. 5 (2006): 999-1005.  Full Text
    • LaPointe, NMA, and Kramer, JM. "Authors' reply." American Heart Journal 152, no. 4 (2006): e45-.  Full Text
    • Newby, LK, Allen-LaPointe, NM, Chen, AY, Kramer, JM, Hammill, BG, DeLong, ER, Muhlbaier, LH, and Califf, RM. "Response to letter regarding article, "Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease" [2]." Circulation 114, no. 6 (2006): e241-.  Full Text
    • Ridley, DB, and Kramer, JM. "Postapproval drug safety: The authors respond [8]." Health Affairs 25, no. 4 (2006): 1187-1188.  Full Text
    • Ridley, DB, and Kramer, JM. "Postapproval drug safety: The authors respond." HEALTH AFFAIRS 25, no. 4 (2006): 1187-1188.  Full Text  Link to Item
    • Kramer, JM. "Managing the risks of therapeutic products: proceedings of a workshop." Pharmacoepidemiol Drug Saf 14, no. 9 (September 2005): 619-628.  Full Text  Link to Item
    • Al-Khatib, SM, Allen LaPointe, NM, Kramer, JM, Chen, AY, Hammill, BG, Delong, L, and Califf, RM. "A survey of health care practitioners' knowledge of the QT interval." Journal of General Internal Medicine 20, no. 5 (May 2005): 392-396.  Full Text
    • O'Shea, JC, Kramer, JM, Califf, RM, and Peterson, ED. "Part I: Identifying holes in the safety net." Am Heart J 147, no. 6 (June 2004): 977-984. (Review)  Full Text  Link to Item
    • Peterson, ED, Hirshfeld, JW, Ferguson, TB, Kramer, JM, Califf, RM, and Kessler, LG. "Part II: Sealing holes in the safety net." Am Heart J 147, no. 6 (June 2004): 985-990. (Review)  Full Text  Link to Item
    • Kramer, JM, Newby, LK, Chang, WC, Simes, RJ, Van de Werf, F, Granger, CB, Lee, KL, White, HD, Piegas, LS, Topol, EJ, Califf, RM, Armstrong, PW, and SYMPHONY and 2nd SYMPHONY Investigators, . "International variation in the use of evidence-based medicines for acute coronary syndromes." Eur Heart J 24, no. 23 (December 2003): 2133-2141.  Link to Item
    • Newby, LK, Bhapkar, MV, White, HD, Moliterno, DJ, LaPointe, NMA, Kandzari, DE, Verheugt, FWA, Kramer, JM, Armstrong, PW, Califf, RM, and SYMPHONY and 2nd SYMPHONY investigators, . "Aspirin use post-acute coronary syndromes: intolerance, bleeding and discontinuation." J Thromb Thrombolysis 16, no. 3 (December 2003): 119-128.  Full Text  Link to Item
    • Allen LaPointe, NM, Chen, A, Hammill, B, DeLong, E, Kramer, JM, and Califf, RM. "Evaluation of the dofetilide risk-management program." Am Heart J 146, no. 5 (November 2003): 894-901.  Full Text  Link to Item
    • LaPointe, NMA, Pamer, CA, and Kramer, JM. "New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance." Pharmacotherapy 23, no. 10 (October 2003): 1316-1321.  Link to Item
    • Kwon, HJ, Coté, TR, Cuffe, MS, Kramer, JM, and Braun, MM. "Case reports of heart failure after therapy with a tumor necrosis factor antagonist." Ann Intern Med 138, no. 10 (May 20, 2003): 807-811. (Review)  Link to Item
    • Al-Khatib, SM, LaPointe, NMA, Kramer, JM, and Califf, RM. "What clinicians should know about the QT interval." JAMA 289, no. 16 (April 23, 2003): 2120-2127. (Review)  Full Text  Link to Item
    • LaPointe, NMA, Al-Khatib, SM, Kramer, JM, and Califf, RM. "Knowledge deficits related to the QT interval could affect patient safety." Ann Noninvasive Electrocardiol 8, no. 2 (April 2003): 157-160.  Link to Item
    • Al-Khatib, SM, LaPointe, NMA, Curtis, LH, Kramer, JM, Swann, J, Honig, P, and Califf, RM. "Outpatient prescribing of antiarrhythmic drugs from 1995 to 2000." Am J Cardiol 91, no. 1 (January 1, 2003): 91-94.  Link to Item
    • Krantz, MJ, Martell, BA, Arnsten, JH, Gourevitch, MN, Gillespie, JA, Clary, CM, Cappuccio, C, Al-Khatib, SM, LaPointe, NMA, Kramer, JM, and Califf, RM. "Medications That Prolong the QT Interval [1] (multiple letters)." Journal of the American Medical Association 290, no. 8 (2003): 1025-1026.  Full Text
    • LaPointe, NMA, Pamer, CA, and Kramer, JM. "New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance." Pharmacotherapy 23, no. 10 II (2003): 1316-1321.  Full Text
    • Cantor, WJ, Miller, JM, Hellkamp, AS, Kramer, JM, Peterson, ED, Hasselblad, V, Zidar, JP, Newby, LK, and Ohman, EM. "Role of target vessel size and body surface area on outcomes after percutaneous coronary interventions in women." Am Heart J 144, no. 2 (August 2002): 297-302.  Link to Item
    • LaPointe, NMA, Kramer, JM, Weinfurt, KP, and Califf, RM. "Practitioner acceptance of the dofetilide risk-management program." Pharmacotherapy 22, no. 8 (August 2002): 1041-1046.  Link to Item
    • Kramer, JM, Bosco, LA, and Califf, RM. "Centers for Education and Research on Therapeutics (CERTs)." Drug Information Journal 36, no. 3 (July 2002): 717-723.  Full Text
    • Shah, MR, Hasselblad, V, Stinnett, SS, Kramer, JM, Grossman, S, Gheorghiade, M, Adams, KF, Swedberg, K, Califf, RM, and O'Connor, CM. "Dissociation between hemodynamic changes and symptom improvement in patients with advanced congestive heart failure." Eur J Heart Fail 4, no. 3 (June 2002): 297-304.  Link to Item
    • Allen LaPointe, NM, Kramer, JM, DeLong, ER, Ostbye, T, Hammill, BG, Muhlbaier, LH, McCants, CB, Chen, A, and Califf, RM. "Patient-reported frequency of taking aspirin in a population with coronary artery disease." Am J Cardiol 89, no. 9 (May 1, 2002): 1042-1046.  Link to Item
    • Califf, RM, DeLong, ER, Ostbye, T, Muhlbaier, LH, Chen, A, LaPointe, NA, Hammill, BG, McCants, CB, and Kramer, JM. "Underuse of aspirin in a referral population with documented coronary artery disease." Am J Cardiol 89, no. 6 (March 15, 2002): 653-661.  Link to Item
    • Kramer, JM, Bosco, LA, and Califf, RM. "Centers for Education and Research on Therapeutics (CERTs)." Drug Information Journal 36, no. 3 (2002): 717-723.
    • Peterson, ED, Lansky, AJ, Kramer, J, Anstrom, K, Lanzilotta, MJ, and National Cardiovascular Network Clinical Investigators, . "Effect of gender on the outcomes of contemporary percutaneous coronary intervention." Am J Cardiol 88, no. 4 (August 15, 2001): 359-364.  Link to Item
    • Califf, RM, and Kramer, JM. "What have we learned from the calcium channel blocker controversy?." Circulation 97, no. 16 (April 28, 1998): 1529-1531.  Link to Item
    • Kase, CS, Pessin, MS, Zivin, JA, del Zoppo, GJ, Furlan, AJ, Buckley, JW, Snipes, RG, and LittleJohn, JK. "Intracranial hemorrhage after coronary thrombolysis with tissue plasminogen activator." Am J Med 92, no. 4 (April 1992): 384-390.  Link to Item
    • LittleJohn, JK. "Package insert: view of a rural town practitioner." Drug Inf J 21, no. 1 (1987): 63-65.  Link to Item

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