Overview
· Optimizing the use of drugs, devices, and biological products in clinical practice.
· Studying methods of risk management for therapeutic products
Current Appointments & Affiliations
Professor Emeritus of Medicine
·
2014 - Present
Medicine, General Internal Medicine,
Medicine
Member in the Duke Clinical Research Institute
·
1997 - Present
Duke Clinical Research Institute,
Institutes and Centers
Recent Publications
Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND.
Journal Article Ther Innov Regul Sci · November 2014 Due to investigators' complaints about the volume and limited interpretability of expedited safety reports received in Investigational New Drug (IND) studies, the authors surveyed industry sponsors in late 2009 about their reporting practices. An Internet- ... Full text Link to item CiteInvestigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.
Journal Article Ther Innov Regul Sci · July 2014 Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these ex ... Full text Link to item CiteOptimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application.
Journal Article Ther Innov Regul Sci · March 2014 In September 2010, the US Food and Drug Administration (FDA) published a final rule governing the requirements for expedited safety reporting for products subject to an investigational new drug application. The rule clarified the types of safety informatio ... Full text Link to item CiteRecent Grants
CTTI U19
ResearchProgram Director · Awarded by Food and Drug Administration · 2009 - 2015Duke Cardiovascular CERTs
ResearchCo Investigator · Awarded by Agency for Healthcare Research and Quality · 2007 - 2012Barriers to Optimal Cardiovascular Medication Use in Diabetes and Renal Disease
ResearchCo-Mentor · Awarded by National Institutes of Health · 2006 - 2011View All Grants
Education, Training & Certifications
University of North Carolina, Chapel Hill ·
1977
M.D.
University of North Carolina, Chapel Hill ·
1972
M.S.
University of North Carolina, Chapel Hill ·
1970
B.S.