Judith Mae Kramer, MD

Professor Emeritus of Medicine
Member in the Duke Clinical Research Institute
Campus mail 2400 Pratt St, Durham, NC 27705
Email address judith.kramer@duke.edu

· Studying methods to facilitate the uptake of evidence-based treatment recommendations.
· Optimizing the use of drugs, devices, and biological products in clinical practice.
· Studying methods of risk management for therapeutic products

Education and Training

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

Publications

Sethi, Sundeep S., Judith M. Kramer, Suzanne Gagnon, Greg Nadzan, and José M. Vega. “Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND.” Ther Innov Regul Sci 48, no. 6 (November 2014): 741–48. https://doi.org/10.1177/2168479014532260.

PMID
30227477
Full Text

Kramer, Judith M., David Vock, Howard E. Greenberg, Cheri Janning, Lynda Szczech, Miklos Salgo, Suzanne Gagnon, and Susan Ellenberg. “Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.” Ther Innov Regul Sci 48, no. 4 (July 2014): 413–19. https://doi.org/10.1177/2168479013520160.

PMID
25419504
Full Text

Archdeacon, Patrick, Cheryl Grandinetti, José M. Vega, David Balderson, and Judith M. Kramer. “Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.” Ther Innov Regul Sci 48, no. 2 (March 2014): 200–207. https://doi.org/10.1177/2168479013509382.

PMID
30227498
Full Text

Alexander, Karen P., David F. Kong, Aijing Z. Starr, Judith Kramer, Karen Chiswell, Asba Tasneem, and Robert M. Califf. “Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.” J Am Heart Assoc 2, no. 5 (September 26, 2013): e000009. https://doi.org/10.1161/JAHA.113.000009.

PMID
24072529
Full Text

Check, Devon K., Kevin P. Weinfurt, Carrie B. Dombeck, Judith M. Kramer, and Kathryn E. Flynn. “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): 560–67. https://doi.org/10.1177/1740774513484393.

PMID
23666951
Full Text

Flynn, Kathryn E., Judith M. Kramer, Carrie B. Dombeck, and Kevin P. Weinfurt. “Participants' perspectives on safety monitoring in clinical trials.” Clin Trials 10, no. 4 (August 2013): 552–59. https://doi.org/10.1177/1740774513484394.

PMID
23644503
Full Text

Flynn, Kathryn E., Cynthia L. Hahn, Judith M. Kramer, Devon K. Check, Carrie B. Dombeck, Soo Bang, Jane Perlmutter, Felix A. Khin-Maung-Gyi, and Kevin P. Weinfurt. “Using central IRBs for multicenter clinical trials in the United States.” Plos One 8, no. 1 (2013): e54999. https://doi.org/10.1371/journal.pone.0054999.

PMID
23383026
Full Text

Velentgas, Priscilla, Anthony A. Amato, Rhonda L. Bohn, K Arnold Chan, Thomas Cochrane, Donnie P. Funch, Inna Dashevsky, et al. “Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.” Pharmacoepidemiol Drug Saf 21, no. 12 (December 2012): 1350–58. https://doi.org/10.1002/pds.3321.

PMID
22807266
Full Text

Landray, M. J., C. Grandinetti, J. M. Kramer, B. W. Morrison, L. Ball, and R. E. Sherman. “Clinical Trials: Rethinking How We Ensure Quality.” Drug Information Journal 46, no. 6 (November 1, 2012): 657–60. https://doi.org/10.1177/0092861512464372.

Full Text

Califf, Robert M., Deborah A. Zarin, Judith M. Kramer, Rachel E. Sherman, Laura H. Aberle, and Asba Tasneem. “Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.” Jama 307, no. 17 (May 2, 2012): 1838–47. https://doi.org/10.1001/jama.2012.3424.

PMID
22550198
Full Text

Pages