A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors.

PubWeight™: 4.42‹?› | Rank: Top 1%

🔗 View Article (PMID 12397192)

Published in N Engl J Med on October 24, 2002

Authors

Kevin A Schulman1, Damon M Seils, Justin W Timbie, Jeremy Sugarman, Lauren A Dame, Kevin P Weinfurt, Daniel B Mark, Robert M Califf

Author Affiliations

1: Center for Clinical and Genetic Economics, Duke University Medical Center, Durham, NC, USA. kevin.schulman@duke.edu

Articles citing this

Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development. Arthritis Res Ther (2004) 2.07

Biomedical conflicts of interest: a defence of the sequestration thesis-learning from the cases of Nancy Olivieri and David Healy. J Med Ethics (2004) 1.58

Facing the evidence: antidepressant treatment in children and adolescents. CMAJ (2004) 1.45

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest. Clin Transl Med (2015) 1.41

Getting it right: industry sponsorship and medical research. CMAJ (2003) 1.29

The controlling interests of research. CMAJ (2002) 1.12

Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents. PLoS One (2008) 1.09

Sponsors' participation in conduct and reporting of industry trials: a descriptive study. Trials (2012) 1.04

Institutions, contracts, and academic freedom. N Engl J Med (2002) 1.00

Investigator experiences with financial conflicts of interest in clinical trials. Trials (2011) 0.98

Institutional ethics review of clinical study agreements. J Med Ethics (2004) 0.89

Observational study of contracts processing at 29 CTSA sites. Clin Transl Sci (2013) 0.84

The need for a transparent, ethical, and successful relationship between academic scientists and the pharmaceutical industry: a view of the Group for the Respect of Ethics and Excellence in Science (GREES). Osteoporos Int (2010) 0.82

Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med (2016) 0.82

Criteria for evaluating tobacco control research funding programs and their application to models that include financial support from the tobacco industry. Tob Control (2009) 0.81

Finer nuances of clinical study agreements for research trials. Indian J Ophthalmol (2008) 0.81

Public welfare agenda or corporate research agenda? Mens Sana Monogr (2005) 0.78

Toward effective Canadian public-private partnerships in health research. CMAJ (2003) 0.77

Ethical obligation towards research subjects. Mens Sana Monogr (2007) 0.75

Marketing, media, wishful thinking, and conflicts of interest: inflating the value of new medical technology. Perm J (2009) 0.75

Clinical research: a tale of two studies. Trans Am Clin Climatol Assoc (2003) 0.75

Clinical-trial agreements between medical schools and industry. N Engl J Med (2003) 0.75

Clinical-trial agreements between medical schools and industry. N Engl J Med (2003) 0.75

Managing conflict of interest: sense and sensibility. Clin Biochem Rev (2005) 0.75

Concerned Journals, Editors And ICMJE. Mens Sana Monogr (2007) 0.75

Clinical-trial agreements between medical schools and industry. N Engl J Med (2003) 0.75

Conforming to ICMJE principles. CMAJ (2005) 0.75

An Analysis of Sponsors/Collaborators of 69,160 Drug Trials Registered with ClinicalTrials.gov. PLoS One (2016) 0.75

Academic medical centers, private industry, and clinical trials: how do we achieve fairness, objectivity, and balance? Int Urogynecol J Pelvic Floor Dysfunct (2007) 0.75

The Is-Ought Problem in Practical Ethics. HEC Forum (2017) 0.75

Articles by these authors

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med (2011) 28.99

Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med (2005) 27.36

The limitations of "vulnerability" as a protection for human research participants. Am J Bioeth (2004) 14.06

Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med (2015) 13.90

Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA (2009) 13.69

Ethical and scientific implications of the globalization of clinical research. N Engl J Med (2009) 11.42

Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med (2003) 10.57

ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-Elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction) developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. J Am Coll Cardiol (2007) 10.19

The ClinicalTrials.gov results database--update and key issues. N Engl J Med (2011) 9.83

Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA (2004) 9.74

Relation between renal dysfunction and cardiovascular outcomes after myocardial infarction. N Engl J Med (2004) 9.13

Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med (2006) 8.74

Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med (2015) 8.70

Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA (2002) 8.28

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA (2006) 7.81

A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med (2013) 7.09

Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. N Engl J Med (2005) 6.86

ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation (2007) 6.78

Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness: the ESCAPE trial. JAMA (2005) 6.10

Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA (2005) 5.93

Patients' views on identifiability of samples and informed consent for genetic research. Am J Bioeth (2008) 5.73

Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med (2010) 5.46

Dealing with the long-term social implications of research. Am J Bioeth (2011) 5.41

Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA (2013) 5.31

Research ethics recommendations for whole-genome research: consensus statement. PLoS Biol (2008) 5.24

Endoscopic versus open vein-graft harvesting in coronary-artery bypass surgery. N Engl J Med (2009) 5.19

Depression and coronary heart disease: recommendations for screening, referral, and treatment: a science advisory from the American Heart Association Prevention Committee of the Council on Cardiovascular Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Psychiatric Association. Circulation (2008) 5.15

Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med (2008) 5.13

Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes. JAMA (2004) 5.11

Ethics and best practice guidelines for training experiences in global health. Am J Trop Med Hyg (2010) 5.05

Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. Lancet (2002) 5.04

Medical and nursing students' television viewing habits: potential implications for bioethics. Am J Bioeth (2008) 4.94

Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med (2003) 4.72

Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med (2008) 4.64

ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol (2002) 4.64

ACC/AHA 2002 guideline update for exercise testing: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). Circulation (2002) 4.56

ACC/AHA 2002 guideline update for exercise testing: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). J Am Coll Cardiol (2002) 4.48

What clinicians should know about the QT interval. JAMA (2003) 4.45

Effect of nateglinide on the incidence of diabetes and cardiovascular events. N Engl J Med (2010) 4.38

Depression as a risk factor for mortality after coronary artery bypass surgery. Lancet (2003) 4.21

Compliance with results reporting at ClinicalTrials.gov. N Engl J Med (2015) 4.17

Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation (2012) 4.10

Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation (2006) 3.96

Clinical and economic implications of the Multicenter Automatic Defibrillator Implantation Trial-II. Ann Intern Med (2005) 3.83

ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--2002: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). Circulation (2002) 3.80

Prognostic value of growth-differentiation factor-15 in patients with non-ST-elevation acute coronary syndrome. Circulation (2007) 3.62

Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med (2004) 3.58

Evolution of adverse changes in stored RBCs. Proc Natl Acad Sci U S A (2007) 3.58

Role of microvolt T-wave alternans in assessment of arrhythmia vulnerability among patients with heart failure and systolic dysfunction: primary results from the T-wave alternans sudden cardiac death in heart failure trial substudy. Circulation (2008) 3.54

Comparative efficacy of dronedarone and amiodarone for the maintenance of sinus rhythm in patients with atrial fibrillation. J Am Coll Cardiol (2009) 3.54

Impact of the pulmonary artery catheter in critically ill patients: meta-analysis of randomized clinical trials. JAMA (2005) 3.51

Ethical goals of community consultation in research. Am J Public Health (2005) 3.46

The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J Thorac Cardiovasc Surg (2007) 3.45

Effect of an implantable gentamicin-collagen sponge on sternal wound infections following cardiac surgery: a randomized trial. JAMA (2010) 3.39

2011 ACCF/AHA focused update incorporated into the ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American Academy of Family Physicians, Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. J Am Coll Cardiol (2011) 3.37

Cardiorenal interactions: insights from the ESCAPE trial. J Am Coll Cardiol (2008) 3.35

Secondary analysis of the CHOIR trial epoetin-alpha dose and achieved hemoglobin outcomes. Kidney Int (2008) 3.34

Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol (2003) 3.31

Short-term intravenous milrinone for acute exacerbation of chronic heart failure: a randomized controlled trial. JAMA (2002) 3.24

Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med (2013) 3.08

The cost of institutional review boards in academic medical centers. N Engl J Med (2005) 3.06

Rationale and design of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial): comparison of ezetimbe/simvastatin versus simvastatin monotherapy on cardiovascular outcomes in patients with acute coronary syndromes. Am Heart J (2008) 3.02

Bioethics consultation in the private sector. Hastings Cent Rep (2002) 3.01

Troponin T levels in patients with acute coronary syndromes, with or without renal dysfunction. N Engl J Med (2002) 3.01

The role of academic health science systems in the transformation of medicine. Lancet (2009) 2.98

Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA (2006) 2.92

Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA (2004) 2.89

Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med (2013) 2.86

Lower serum sodium is associated with increased short-term mortality in hospitalized patients with worsening heart failure: results from the Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) study. Circulation (2005) 2.86

Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA (2009) 2.83

Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol (2012) 2.77

2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation (2011) 2.72

The inescapable relevance of bioethics for the practicing clinician. Chest (2006) 2.70

Admission or changes in renal function during hospitalization for worsening heart failure predict postdischarge survival: results from the Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF). Circ Heart Fail (2008) 2.69

New ISSCR guidelines underscore major principles for responsible translational stem cell research. Cell Stem Cell (2008) 2.61

Lessons learned from recent cardiovascular clinical trials: Part I. Circulation (2002) 2.57

Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial. Circulation (2009) 2.57

Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community. Ann Emerg Med (2003) 2.56

Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial. Circulation (2011) 2.52

Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med (2009) 2.49

Ethical considerations for short-term experiences by trainees in global health. JAMA (2008) 2.48

Long-term outcome and its predictors among patients with ST-segment elevation myocardial infarction complicated by shock: insights from the GUSTO-I trial. J Am Coll Cardiol (2007) 2.47

International differences in evolution of early discharge after acute myocardial infarction. Lancet (2004) 2.47

Safety and efficacy of enoxaparin vs unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes who receive tirofiban and aspirin: a randomized controlled trial. JAMA (2004) 2.46

Randomized clinical trials--removing unnecessary obstacles. N Engl J Med (2013) 2.43

Optimizing statin treatment for primary prevention of coronary artery disease. Ann Intern Med (2010) 2.41

Relation between dose of loop diuretics and outcomes in a heart failure population: results of the ESCAPE trial. Eur J Heart Fail (2007) 2.39

Reengineering the national clinical and translational research enterprise: the strategic plan of the National Clinical and Translational Science Awards Consortium. Acad Med (2010) 2.38

2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol (2011) 2.37

Sex Differences in Demographics, Risk Factors, Presentation, and Noninvasive Testing in Stable Outpatients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial. JACC Cardiovasc Imaging (2016) 2.36

Maximizing survival benefit with primary prevention implantable cardioverter-defibrillator therapy in a heart failure population. Circulation (2009) 2.34

The prognostic importance of comorbidity for mortality in patients with stable coronary artery disease. J Am Coll Cardiol (2004) 2.34

Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. Eur Heart J (2011) 2.31

Economic return of clinical trials performed under the pediatric exclusivity program. JAMA (2007) 2.28

Rapid-rate nonsustained ventricular tachycardia found on implantable cardioverter-defibrillator interrogation: relationship to outcomes in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol (2013) 2.28

Central nervous system injury associated with cardiac surgery. Lancet (2006) 2.27

Design and methodology of the Occluded Artery Trial (OAT). Am Heart J (2005) 2.26