Scholars@Duke
Judith Mae Kramer

Judith Mae Kramer

Professor Emeritus of Medicine
Medicine, General Internal Medicine
judith.kramer@duke.edu
Box 3850 Med Ctr, Durham, NC 27710
2400 Pratt St, Durham, NC 27705

Selected 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 Cite

Investigators' 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 Cite

Optimizing 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 Cite

Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.

Journal Article J Am Heart Assoc · September 26, 2013 BACKGROUND: Cardiovascular medicine is widely regarded as a vanguard for evidence-based drug and technology development. Our goal was to describe the cardiovascular clinical research portfolio from ClinicalTrials.gov. METHODS AND RESULTS: We identified 40 ... Full text Open Access Link to item Cite

Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature.

Journal Article Clin Trials · August 2013 BACKGROUND: To improve the efficiency of conducting multicenter clinical trials, the Food and Drug Administration, the Office of Human Research Protections, and the Department of Health and Human Services have expressed support for using a centralized inst ... Full text Link to item Cite

Participants' perspectives on safety monitoring in clinical trials.

Journal Article Clin Trials · August 2013 BACKGROUND: Minimizing the risk to study participants is an essential requirement of ethical research. Respecting the rights of subjects is also paramount, which includes respecting their autonomy by making available important information about the evolvin ... Full text Link to item Cite

Using central IRBs for multicenter clinical trials in the United States.

Journal Article PLoS One · 2013 Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of c ... Full text Link to item Cite

Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.

Journal Article Pharmacoepidemiol Drug Saf · December 2012 PURPOSE: A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain-Barré syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Ce ... Full text Link to item Cite

Clinical Trials: Rethinking How We Ensure Quality

Journal Article Drug Information Journal · November 1, 2012 Full text Open Access Cite

Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.

Journal Article JAMA · May 2, 2012 CONTEXT: Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a com ... Full text Link to item Cite

Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial.

Journal Article Am Heart J · April 2012 BACKGROUND: Nonadherence to cardiovascular medications is a significant public health problem. This randomized study evaluated the effect on medication adherence of linking hospital and community pharmacists. METHODS: Hospitalized patients with coronary ar ... Full text Link to item Cite

Impediments to clinical research in the United States.

Journal Article Clin Pharmacol Ther · March 2012 Clinical trials are essential to the evaluation of promising scientific discoveries, but they are becoming unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing tr ... Full text Link to item Cite

Monitoring the quality of conduct of clinical trials: a survey of current practices.

Journal Article Clin Trials · June 2011 BACKGROUND: There is a little empirical evidence to determine which, if any, monitoring practices best achieve the goals of trial monitoring set forth in ICH E6 under the variable circumstances of different clinical trial settings. PURPOSE: The purpose of ... Full text Link to item Cite

The author replies

Journal Article New England Journal of Medicine · July 9, 2009 Full text Cite

Long-Acting Beta-Agonists in Asthma REPLY

Journal Article NEW ENGLAND JOURNAL OF MEDICINE · July 9, 2009 Link to item Cite

Eligibility criteria for β-blockade might have to be taken into account - Reply

Journal Article Archives of Internal Medicine · June 8, 2009 Cite

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.

Journal Article Am J Cardiol · June 1, 2009 Beta blockers and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEIs/ARBs) are evidence-based medications for chronic heart failure, but little is known about the persistent use and clinical effectiveness of these medications. We ... Full text Link to item Cite

Scientific evidence underlying the ACC/AHA clinical practice guidelines.

Journal Article JAMA · February 25, 2009 CONTEXT: The joint cardiovascular practice guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA) have become important documents for guiding cardiology practice and establishing benchmarks for quality of care. OBJE ... Full text Link to item Cite

Early and long-term outcomes of heart failure in elderly persons, 2001-2005.

Journal Article Arch Intern Med · December 8, 2008 BACKGROUND: The treatment of chronic heart failure has improved during the past 2 decades, but little is known about whether the improvements are reflected in trends in early and long-term mortality and hospital readmission. METHODS: In a retrospective coh ... Full text Link to item Cite

Comparative effectiveness of beta-blockers in elderly patients with heart failure.

Journal Article Archives of internal medicine · December 2008 BACKGROUND: Whether beta-blockers (BBs) other than carvedilol, metoprolol succinate, and bisoprolol fumarate (evidence-based beta-blockers [EBBBs]) improve survival in patients with heart failure (HF) is unknown. We compared the effectiveness of EBBBs vs n ... Cite

A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

Journal Article Pharmacoepidemiol Drug Saf · December 2008 PURPOSE: We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a ... Full text Link to item Cite

Long-term clinical outcomes following coronary stenting.

Journal Article Arch Intern Med · August 11, 2008 BACKGROUND: Clinical trials of drug-eluting stents (DES) vs bare metal stents (BMS) report a reduced need for target lesion revascularization with no difference in death or myocardial infarction. However, these trials selectively enrolled patients with low ... Full text Link to item Cite

Postmarket evaluation of breakthrough technologies.

Journal Article Am Heart J · August 2008 Cardiovascular procedures performed in the United States have more than tripled in the last decade, a trend that is expected to continue with the aging of the population, coupled with epidemics of obesity and diabetes mellitus. Helping to drive this increa ... Full text Link to item Cite

A randomized trial of direct-to-patient communication to enhance adherence to beta-blocker therapy following myocardial infarction.

Journal Article Arch Intern Med · March 10, 2008 BACKGROUND: Although beta-blockers are routinely prescribed at hospital discharge after myocardial infarction (MI), patients' adherence has been shown to decline substantially over time. We sought to test the hypothesis that a simple, direct-to-patient int ... Full text Link to item Cite

Heart failure among younger rheumatoid arthritis and Crohn's patients exposed to TNF-alpha antagonists.

Journal Article Rheumatology (Oxford) · November 2007 OBJECTIVES: New onset heart failure (HF) has been associated with the use of TNF-alpha antagonists etanercept and infliximab based upon spontaneous adverse event reports. HF clinical trials of these agents were stopped early due to futility or worsening of ... Full text Link to item Cite

Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases.

Journal Article Med Care · October 2007 Inverse probability-weighted estimation is a powerful tool for use with observational data. In this article, we describe how this propensity score-based method can be used to compare the effectiveness of 2 or more treatments. First, we discuss the inherent ... Full text Link to item Cite

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation.

Journal Article JAMA · January 10, 2007 CONTEXT: Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. OBJECTIVE: To assess the association between clopidogrel use and long-term clinical outcomes of ... Full text Link to item Cite

National evaluation of adherence to beta-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance.

Journal Article Am Heart J · September 2006 BACKGROUND: Quality measures of evidence-based medications post-myocardial infarction have focused on prescription at hospital discharge. Yet survival benefits of these medications are best realized with sustained therapy. We sought to examine long-term be ... Full text Link to item Cite

Frequency of high-risk use of QT-prolonging medications.

Journal Article Pharmacoepidemiol Drug Saf · June 2006 PURPOSE: Prolongation of the QT interval has been associated with increased risk of torsades de pointes and death. Concurrent use of more than one QT-prolonging drug or a QT-prolonging drug with a drug that alters its pharmacokinetic profile is an importan ... Full text Link to item Cite

Multifaceted intervention to promote beta-blocker use in heart failure.

Journal Article Am Heart J · May 2006 BACKGROUND: Despite a survival benefit and guideline recommendation for beta-blockers in left ventricular systolic dysfunction, beta-blockers are underused in clinical practice. METHODS: Medical practices with > or = 15 patients with heart failure (HF) in ... Full text Link to item Cite

How obesity affects the cut-points for B-type natriuretic peptide in the diagnosis of acute heart failure. Results from the Breathing Not Properly Multinational Study.

Journal Article Am Heart J · May 2006 BACKGROUND: B-type natriuretic peptide (BNP) is valuable in diagnosing heart failure (HF), but its utility in obese patients is unknown. Studies have suggested a cut-point of BNP > or = 100 pg/mL for the diagnosis of HF; however, there is an inverse relati ... Full text Link to item Cite

Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease.

Journal Article Circulation · January 17, 2006 BACKGROUND: Studies have examined the use of evidence-based therapies for coronary artery disease (CAD) in the short term and at hospital discharge, but few have evaluated long-term use. METHODS AND RESULTS: Using the Duke Databank for Cardiovascular Disea ... Full text Link to item Cite

Spending on postapproval drug safety.

Journal Article Health Aff (Millwood) · 2006 Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on ... Full text Open Access Link to item Cite

Authors' reply

Journal Article American Heart Journal · 2006 Full text Cite

Postapproval drug safety: The authors respond [8]

Journal Article Health Affairs · January 1, 2006 Full text Cite

Postapproval drug safety: The authors respond

Journal Article HEALTH AFFAIRS · 2006 Full text Cite

Managing the risks of therapeutic products: proceedings of a workshop.

Journal Article Pharmacoepidemiol Drug Saf · September 2005 Featured Publication Traditional tools available to the Food and Drug Administration for managing known risks of therapeutic products (drugs, devices and biological products) have limited effectiveness. This report presents the recommendations of a multidisciplinary workshop f ... Full text Link to item Cite

A survey of health care practitioners' knowledge of the QT interval.

Journal Article J Gen Intern Med · May 2005 Featured Publication OBJECTIVE: To assess health care practitioners' ability to correctly measure the QT interval, and to identify factors and medications that may increase the risk of QT-interval prolongation and torsades de pointes. DESIGN: A cross-sectional analysis of a su ... Full text Link to item Cite

Part II: Sealing holes in the safety net.

Journal Article Am Heart J · June 2004 Featured Publication Full text Link to item Cite

Part I: Identifying holes in the safety net.

Journal Article Am Heart J · June 2004 Featured Publication Full text Link to item Cite

International variation in the use of evidence-based medicines for acute coronary syndromes.

Journal Article Eur Heart J · December 2003 Featured Publication AIMS: We sought to evaluate international patterns of use and factors influencing use of evidence-based medications early after ACS. METHODS AND RESULTS: Using a database of 15904 ACS patients enrolled in the SYMPHONY and 2nd SYMPHONY trials in 37 countrie ... Full text Link to item Cite

Aspirin use post-acute coronary syndromes: intolerance, bleeding and discontinuation.

Journal Article J Thromb Thrombolysis · December 2003 Featured Publication BACKGROUND: While aspirin's secondary prevention benefit is clear, prior reports indicate that 19-83% of eligible patients may not use aspirin chronically. METHODS: We investigated intolerance and bleeding while on aspirin and aspirin discontinuation using ... Full text Link to item Cite

Evaluation of the dofetilide risk-management program.

Journal Article Am Heart J · November 2003 Featured Publication BACKGROUND: Dose-dependent torsades de pointes has been shown to occur with dofetilide (Tikosyn) and sotalol HCl (Betapace AF); thus, detailed dosing and monitoring recommendations to minimize this risk are included in the product labeling for both drugs. ... Full text Link to item Cite

New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance.

Journal Article Pharmacotherapy · October 2003 Featured Publication OBJECTIVE: To determine how well dofetilide and Betapace AF (sotalol, approved solely for atrial fibrillation and atrial flutter), with their detailed dosing and monitoring guidelines for safety, were accepted into clinical practice during the 2 calendar y ... Full text Link to item Cite

Case reports of heart failure after therapy with a tumor necrosis factor antagonist.

Journal Article Ann Intern Med · May 20, 2003 Featured Publication BACKGROUND: Etanercept and infliximab are U.S. Food and Drug Administration-approved tumor necrosis factor (TNF) antagonists. OBJECTIVE: To describe adverse event reports of heart failure after TNF antagonist therapy. DESIGN: Case series. SETTING: The U.S. ... Full text Link to item Cite

What clinicians should know about the QT interval.

Journal Article JAMA · April 23, 2003 Featured Publication CONTEXT: Of the several factors implicated in causing QT interval prolongation and torsades de pointes, errors in the use of medications that may prolong this interval deserve special attention. OBJECTIVE: To systematically summarize the available clinical ... Full text Link to item Cite

Knowledge deficits related to the QT interval could affect patient safety.

Journal Article Ann Noninvasive Electrocardiol · April 2003 Featured Publication BACKGROUND: Recently, some QT-prolonging, noncardiac medications were withdrawn from the U.S. drug market because of continued inappropriate use by health care practitioners despite warnings and label changes from both the drug manufacturers and the U.S. F ... Full text Link to item Cite

Outpatient prescribing of antiarrhythmic drugs from 1995 to 2000.

Journal Article Am J Cardiol · January 1, 2003 Featured Publication Full text Link to item Cite

Practitioner acceptance of the dofetilide risk-management program.

Journal Article Pharmacotherapy · August 2002 Featured Publication STUDY OBJECTIVE: To assess the opinions and knowledge retention of practitioners after participation in the dofetilide risk-management program. DESIGN: A 21-item questionnaire. SETTING: A large academic medical center. PARTICIPANTS: One hundred forty-six p ... Full text Link to item Cite

Role of target vessel size and body surface area on outcomes after percutaneous coronary interventions in women.

Journal Article Am Heart J · August 2002 Featured Publication BACKGROUND: Women have higher mortality rates than men after coronary angioplasty. Differences in target vessel size may partially account for these differences. We set out to explore the effects of sex, body surface area (BSA), and target coronary vessel ... Full text Link to item Cite

Dissociation between hemodynamic changes and symptom improvement in patients with advanced congestive heart failure.

Journal Article Eur J Heart Fail · June 2002 Featured Publication BACKGROUND: Changes in hemodynamic measures often serve as surrogate end points in efficacy trials for advanced heart failure, although there are few objective data to support this practice. AIMS: We compared changes in hemodynamic variables vs. changes in ... Full text Link to item Cite

Patient-reported frequency of taking aspirin in a population with coronary artery disease.

Journal Article Am J Cardiol · May 1, 2002 Featured Publication Despite the established benefits of antiplatelet agents in coronary artery disease (CAD), many appropriate patients are not receiving them. We investigated the prevalence of and factors associated with aspirin use and nonuse within a large referral populat ... Full text Link to item Cite

Underuse of aspirin in a referral population with documented coronary artery disease.

Journal Article Am J Cardiol · March 15, 2002 Featured Publication Despite substantial evidence that antiplatelet therapy saves lives and reduces adverse events in patients with coronary artery disease (CAD), use of the most widely available and lowest cost antiplatelet agent, aspirin, continues to be disappointingly low. ... Full text Link to item Cite

Centers for Education and Research on Therapeutics (CERTs)

Journal Article Drug Information Journal · 2002 The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative authorized by the Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 105-115) as a public-private partnership. The program is administered by the Agenc ... Cite

Effect of gender on the outcomes of contemporary percutaneous coronary intervention.

Journal Article Am J Cardiol · August 15, 2001 Limited information exists regarding the outcomes of newer percutaneous coronary intervention (PCI) technologies in women. This study sought to determine whether female gender is an independent risk factor for PCI mortality and/or complications in contempo ... Full text Link to item Cite

What have we learned from the calcium channel blocker controversy?

Journal Article Circulation · April 28, 1998 Featured Publication Full text Link to item Cite

Intracranial hemorrhage after coronary thrombolysis with tissue plasminogen activator.

Journal Article Am J Med · April 1992 Featured Publication PURPOSE AND METHODS: We analyzed the clinical, laboratory, and radiologic data in nine patients who sustained an intracranial hemorrhage (ICH) after receiving intravenous recombinant tissue plasminogen activator (rt-PA) and heparin for treatment of acute m ... Full text Link to item Cite

Package insert: view of a rural town practitioner.

Journal Article Drug Inf J · 1987 Featured Publication Consideration of how the practitioner uses the package insert leads to constructive suggestions relating to the content and format of the insert. These suggestions primarily relate to the handling of adverse experience reporting. It is suggested that the p ... Full text Link to item Cite