Safety and transparency of pediatric drug trials.

Innovative clinical trial design for pediatric therapeutics. Expert Rev Clin Pharmacol (2011) 1.64

The status of paediatric medicines initiatives around the world--What has happened and what has not? Eur J Clin Pharmacol (2011) 1.26

Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry. Pediatrics (2012) 1.19

A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007. BMC Pediatr (2010) 1.15

Pediatric clinical trials. Perspect Clin Res (2013) 0.85

Anesthetic use in newborn infants: the urgent need for rigorous evaluation. Pediatr Res (2015) 0.79

Clinician uptake of obesity-related drug information: a qualitative assessment using continuing medical education activities. Nutr J (2013) 0.75

Novel therapies, high-risk pediatric research, and the prospect of benefit: learning from the ethical disagreements. Mol Ther (2012) 0.75

Analysis of pediatric clinical drug trials for neuropsychiatric conditions. Pediatrics (2013) 0.75

Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA (1998) 9.91

Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry (2006) 7.60

Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ (2004) 4.53

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

Effects of sibutramine treatment in obese adolescents: a randomized trial. Ann Intern Med (2006) 2.38

Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients--FDA. Final rule. Fed Regist (1998) 2.31

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

Oxcarbazepine adjunctive therapy in infants and young children with partial seizures. Neurology (2005) 2.13

Safety of budesonide inhalation suspension in infants aged six to twelve months with mild to moderate persistent asthma or recurrent wheeze. J Pediatr (2005) 2.09

Double-blind placebo-controlled trial of adjunctive levetiracetam in pediatric partial seizures. Neurology (2006) 1.81

An update on the therapeutic orphan. Pediatrics (1999) 1.52

Tolterodine treatment for children with symptoms of urinary urge incontinence suggestive of detrusor overactivity: results from 2 randomized, placebo controlled trials. J Urol (2005) 1.44

Interferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics. Hepatology (2005) 1.40

Glimepiride versus metformin as monotherapy in pediatric patients with type 2 diabetes: a randomized, single-blind comparative study. Diabetes Care (2007) 1.22

Pharmacokinetic and pharmacodynamic data collection in children and neonates. A quiet frontier. Clin Pharmacokinet (1992) 0.93

Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities. Paediatr Drugs (2008) 0.88

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

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

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

Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med (2007) 6.22

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

Sports medicine and ethics. Am J Bioeth (2013) 5.51

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

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

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

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

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

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

HIV viral load monitoring in resource-limited regions: optional or necessary? Clin Infect Dis (2006) 4.56

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

A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med (2002) 4.42

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

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

Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics (2006) 3.78

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

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

Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA (2003) 3.58

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

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

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

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

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

Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab (2010) 2.99

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

A microfluidic device for practical label-free CD4(+) T cell counting of HIV-infected subjects. Lab Chip (2006) 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

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

Coronary artery involvement in children with Kawasaki disease: risk factors from analysis of serial normalized measurements. Circulation (2007) 2.76

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

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

Between-hospital variation in treatment and outcomes in extremely preterm infants. N Engl J Med (2015) 2.59

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

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

Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity. Pediatrics (2010) 2.48

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

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

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

Beyond detuning: 10 years of progress and new challenges in the development and application of assays for HIV incidence estimation. AIDS (2010) 2.43

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

Prediction of bronchopulmonary dysplasia by postnatal age in extremely premature infants. Am J Respir Crit Care Med (2011) 2.31

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

A cross-sectional study of exercise performance during the first 2 decades of life after the Fontan operation. J Am Coll Cardiol (2008) 2.30

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

Cognitive behavioral therapy and aerobic exercise for Gulf War veterans' illnesses: a randomized controlled trial. JAMA (2003) 2.26

Prognostic implications of left ventricular mass and geometry following myocardial infarction: the VALIANT (VALsartan In Acute myocardial iNfarcTion) Echocardiographic Study. JACC Cardiovasc Imaging (2008) 2.24

Early statin initiation and outcomes in patients with acute coronary syndromes. JAMA (2002) 2.23

Differential case ascertainment in clinical registry versus administrative data and impact on outcomes assessment for pediatric cardiac operations. Ann Thorac Surg (2012) 2.22

Effect of antecedent hypertension and follow-up blood pressure on outcomes after high-risk myocardial infarction. Hypertension (2007) 2.22

Comparison of omapatrilat and enalapril in patients with chronic heart failure: the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE). Circulation (2002) 2.20

Sensible approaches for reducing clinical trial costs. Clin Trials (2008) 2.20

Evolution of the coronary care unit: clinical characteristics and temporal trends in healthcare delivery and outcomes. Crit Care Med (2010) 2.19

Sex differences in mortality following acute coronary syndromes. JAMA (2009) 2.17

Prognostic value of serial B-type natriuretic peptide testing during follow-up of patients with unstable coronary artery disease. JAMA (2005) 2.17

Outcomes of discontinuing rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: analysis from the ROCKET AF trial (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). J Am Coll Cardiol (2013) 2.17

Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome. Am Heart J (2007) 2.14

An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase. Am J Med (2002) 2.12

Relationship between depressive symptoms and long-term mortality in patients with heart failure. Am Heart J (2007) 2.12

The failure of orally administered glycoprotein IIb/IIIa inhibitors to prevent recurrent cardiac events. Am J Med (2002) 2.09

Pulmonary artery catheterization in acute coronary syndromes: insights from the GUSTO IIb and GUSTO III trials. Am J Med (2005) 2.08

Practice standards for electrocardiographic monitoring in hospital settings: an American Heart Association scientific statement from the Councils on Cardiovascular Nursing, Clinical Cardiology, and Cardiovascular Disease in the Young: endorsed by the International Society of Computerized Electrocardiology and the American Association of Critical-Care Nurses. Circulation (2004) 2.04

Risk stratification after hospitalization for decompensated heart failure. J Card Fail (2004) 2.04

Serial measurement of monocyte chemoattractant protein-1 after acute coronary syndromes: results from the A to Z trial. J Am Coll Cardiol (2007) 2.03

Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. Circulation (2010) 2.00

Sustained ventricular tachycardia and ventricular fibrillation complicating non-ST-segment-elevation acute coronary syndromes. Circulation (2012) 1.99