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

  • Academic 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." Journal of the American Heart Association 2, no. 5 (September 26, 2013): e000009-null.  Full Text  Open Access Copy
    • 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." Clinical Trials (London, England) 10, no. 4 (August 2013): 560-567. (Review)  Full Text
    • Flynn, KE, Kramer, JM, Dombeck, CB, and Weinfurt, KP. "Participants' perspectives on safety monitoring in clinical trials." Clinical Trials (London, England) 10, no. 4 (August 2013): 552-559.  Full Text
    • 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 (January 30, 2013): e54999-null.  Full Text
    • 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 (December 2012): 1350-1358.  Full Text
    • 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 1, 2012): 657-660.  Full Text  Open Access Copy
    • 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 2012): 1838-1847.  Full Text
    • 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." American Heart Journal 163, no. 4 (April 2012): 657-65.e1.  Full Text
    • Kramer, JM, Smith, PB, and Califf, RM. "Impediments to clinical research in the United States." Clinical Pharmacology and Therapeutics 91, no. 3 (March 2012): 535-541.  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 (London, England) 8, no. 3 (June 2011): 342-349.  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 (August 2009): 206-209.  Full Text
    • Kramer, JM. "The author replies." New England Journal of Medicine 361, no. 2 (July 9, 2009): 209-null. (Letter)  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
    • 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 (June 8, 2009): 1078-null. (Letter)
    • 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." The American Journal of Cardiology 103, no. 11 (June 2009): 1518-1524.  Full Text
    • 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 2009): 831-841.  Full Text
    • 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
    • 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." Archives of Internal Medicine 168, no. 22 (December 2008): 2481-2488.  Full Text
    • 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." Archives of Internal Medicine 168, no. 15 (August 2008): 1647-1655.  Full Text
    • Califf, RM, and Kramer, JM. "The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment." Pharmacoepidemiology and Drug Safety 17, no. 8 (August 2008): 782-786.  Full Text
    • 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." American Heart Journal 156, no. 2 (August 2008): 201-208.  Full Text
    • 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 beta-blocker therapy following myocardial infarction." Archives of Internal Medicine 168, no. 5 (March 2008): 477-447.  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, 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-alpha antagonists." Rheumatology (Oxford, England) 46, no. 11 (November 2007): 1688-1693.  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 Supl 2 (October 2007): S103-S107.  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 (October 1, 2007).
    • 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 (March 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
    • 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 2007): 159-168.  Full Text
    • Allen LaPointe, NM, and Kramer, JM. "Authors' reply." American Heart Journal 152, no. 4 (October 2006): e45-e45.  Full Text
    • 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." American Heart Journal 152, no. 3 (September 2006): 454.e1-454.e8.  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 (August 1, 2006). (Letter)  Full Text
    • 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
    • Allen LaPointe, NM, 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 (May 1, 2006): 999-1005.  Full Text
    • 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." American Heart Journal 151, no. 5 (May 2006): 992-998.  Full Text
    • 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 9, 2006): 203-212.  Full Text
    • Ridley, DB, and Kramer, JM. "Postapproval drug safety: The authors respond [8]." Health Affairs 25, no. 4 (January 1, 2006): 1187-1188. (Letter)  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." American Heart Journal 147, no. 6 (June 2004): 977-984. (Review)  Full Text
    • Peterson, ED, Hirshfeld, JW, Ferguson, TB, Kramer, JM, Califf, RM, and Kessler, LG. "Part II: Sealing holes in the safety net." American Heart Journal 147, no. 6 (June 2004): 985-990. (Review)  Full Text
    • 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." European Heart Journal 24, no. 23 (December 2003): 2133-2141.  Full Text
    • 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." Journal of Thrombosis and Thrombolysis 16, no. 3 (December 2003): 119-128.  Full Text
    • Allen LaPointe, NM, Chen, A, Hammill, B, DeLong, E, Kramer, JM, and Califf, RM. "Evaluation of the dofetilide risk-management program." American Heart Journal 146, no. 5 (November 2003): 894-901.  Full Text
    • Allen LaPointe, NM, 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 (October 1, 2003): 1316-1321. (Review)  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 (October 2003): 1316-1321.  Link to Item
    • Krantz, MJ, Martell, BA, Arnsten, JH, and Gourevitch, MN. "Medications that prolong the QT interval." Jama 290, no. 8 (August 2003): 1025-null. (Letter)  Full Text
    • Kwon, HJ, Coté, TR, Cuffe, MS, Kramer, JM, and Braun, MM. "Case reports of heart failure after therapy with a tumor necrosis factor antagonist." Annals of Internal Medicine 138, no. 10 (May 2003): 807-811. (Review)  Full Text
    • Al-Khatib, SM, LaPointe, NMA, Kramer, JM, and Califf, RM. "What clinicians should know about the QT interval." Jama 289, no. 16 (April 2003): 2120-2127. (Review)  Full Text
    • LaPointe, NMA, Al-Khatib, SM, Kramer, JM, and Califf, RM. "Knowledge deficits related to the QT interval could affect patient safety." Annals of Noninvasive Electrocardiology : the Official Journal of the International Society for Holter and Noninvasive Electrocardiology, Inc 8, no. 2 (April 2003): 157-160.  Full Text
    • 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." The American Journal of Cardiology 91, no. 1 (January 2003): 91-94.  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." American Heart Journal 144, no. 2 (August 2002): 297-302.  Full Text
    • 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.  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." European Journal of Heart Failure 4, no. 3 (June 2002): 297-304.  Full Text
    • 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." The American Journal of Cardiology 89, no. 9 (May 2002): 1042-1046.  Full Text
    • 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." The American Journal of Cardiology 89, no. 6 (March 2002): 653-661.  Full Text
    • Kramer, JM, Bosco, LA, and Califf, RM. "Centers For Education And Research On Therapeutics (Certs)." Therapeutic Innovation &Amp; Regulatory Science 36, no. 3 (January 1, 2002): 717-723.  Full Text
    • Kramer, JM, Bosco, LA, and Califf, RM. "Centers for Education and Research on Therapeutics (CERTs)." Drug Information Journal 36, no. 3 (January 1, 2002): 717-723. (Review)  Full Text
    • 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." The American Journal of Cardiology 88, no. 4 (August 2001): 359-364.  Full Text
    • Califf, RM, and Kramer, JM. "What have we learned from the calcium channel blocker controversy?." Circulation 97, no. 16 (April 1998): 1529-1531.  Full Text
    • 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 Information Journal 21, no. 1 (January 1987): 63-65.  Full Text

  • 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

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