Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Round Table of the European Society of Cardiology

Pharmacogenomic Determinants of the Cardiovascular Effects of DalcetrapibCLINICAL PERSPECTIVE

(2015) Jean-Claude Tardif et al.   Circulation-Cardiovascular Genetics

Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial

(2015) Frederick J Raal et al.   LANCET

PCSK9 inhibition with evolocumab (AMG 145) in heterozygous familial hypercholesterolaemia (RUTHERFORD-2): a randomised, double-blind, placebo-controlled trial

(2015) Frederick J Raal et al.   LANCET

Pharmacogenomic Determinants of the Cardiovascular Effects of DalcetrapibCLINICAL PERSPECTIVE

(2015) Jean-Claude Tardif et al.   Circulation-Cardiovascular Genetics

Large streamlined trials in cardiovascular disease

(2014) G. Calvo et al.   EUROPEAN HEART JOURNAL

The continuum of personalized cardiovascular medicine: a position paper of the European Society of Cardiology

(2014) Paulus Kirchhof et al.   EUROPEAN HEART JOURNAL

Mendelian randomization studies in coronary artery disease

(2014) H. Jansen et al.   EUROPEAN HEART JOURNAL

Analysing recurrent hospitalizations in heart failure: a review of statistical methodology, with application to CHARM-Preserved

(2014) Jennifer K. Rogers et al.   EUROPEAN JOURNAL OF HEART FAILURE

Effect of Darapladib on Major Coronary Events After an Acute Coronary Syndrome

(2014) Michelle L. O’Donoghue et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Effect of Evolocumab or Ezetimibe Added to Moderate- or High-Intensity Statin Therapy on LDL-C Lowering in Patients With Hypercholesterolemia

(2014) Jennifer G. Robinson et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Assessing the Clinical Benefits of Lipid-Disorder Drugs

(2014) William R. Hiatt et al.   NEW ENGLAND JOURNAL OF MEDICINE

A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia

(2014) Dirk J. Blom et al.   NEW ENGLAND JOURNAL OF MEDICINE

Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients

(2014)   NEW ENGLAND JOURNAL OF MEDICINE

Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive Attitude

(2013) F Ehmann et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Personalized management of atrial fibrillation: Proceedings from the fourth Atrial Fibrillation competence NETwork/European Heart Rhythm Association consensus conference

(2013) P. Kirchhof et al.   EUROPACE

Cardiovascular disease in Europe: epidemiological update

(2013) Melanie Nichols et al.   EUROPEAN HEART JOURNAL

Championing cardiovascular health innovation in Europe

(2013) Michel Komajda et al.   EUROPEAN HEART JOURNAL

Trends in age-specific coronary heart disease mortality in the European Union over three decades: 1980–2009

(2013) Melanie Nichols et al.   EUROPEAN HEART JOURNAL

Clinical Advances in Molecular Biomarkers for Cancer Diagnosis and Therapy

(2013) Seema Sethi et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

An adaptive-design dose-ranging study of PD 0348292, an oral factor Xa inhibitor, for thromboprophylaxis after total knee replacement surgery

(2013) A. T. Cohen et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Randomized Clinical Trials — Removing Unnecessary Obstacles

(2013) Christina Reith et al.   NEW ENGLAND JOURNAL OF MEDICINE

Are Routinely Collected NHS Administrative Records Suitable for Endpoint Identification in Clinical Trials? Evidence from the West of Scotland Coronary Prevention Study

(2013) Sarah J. E. Barry et al.   PLoS One

Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

(2012) H-G Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A statistical approach to central monitoring of data quality in clinical trials

(2012) David Venet et al.   Clinical Trials

Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop

(2012) Christopher S Coffey et al.   Clinical Trials

Mortality from ischaemic heart disease by country, region, and age: Statistics from World Health Organisation and United Nations

(2012) Judith A. Finegold et al.   INTERNATIONAL JOURNAL OF CARDIOLOGY

Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study

(2012) Michael J Koren et al.   LANCET

Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study

(2012) Robert P Giugliano et al.   LANCET

Effect of a monoclonal antibody to PCSK9, REGN727/SAR236553, to reduce low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolaemia on stable statin dose with or without ezetimibe therapy: a phase 2 randomised controlled trial

(2012) Evan A Stein et al.   LANCET

Plasma HDL cholesterol and risk of myocardial infarction: a mendelian randomisation study

(2012) Benjamin F Voight et al.   LANCET

Interleukin-6 receptor pathways in coronary heart disease: a collaborative meta-analysis of 82 studies

(2012)   LANCET

Diagnosing the decline in pharmaceutical R&D efficiency

(2012) Jack W. Scannell et al.   NATURE REVIEWS DRUG DISCOVERY

A conditional error function approach for subgroup selection in adaptive clinical trials

(2012) T. Friede et al.   STATISTICS IN MEDICINE

ACCF/AHA 2011 Key Data Elements and Definitions of a Base Cardiovascular Vocabulary for Electronic Health Records

(2011) et al.   CIRCULATION

Designing a seamless phase II/III clinical trial using early outcomes for treatment selection: An application in multiple sclerosis

(2011) T. Friede et al.   STATISTICS IN MEDICINE

Recruiting patients cost-effectively by mail

(2011) Theingi Aung et al.   Trials

Comments on the FDA Draft Guidance on Adaptive Designs

(2010) Janet Wittes   Journal of Biopharmaceutical Statistics

Adaptive Methods: Telling “The Rest of the Story”

(2010) Scott S. Emerson et al.   Journal of Biopharmaceutical Statistics

Rolofylline, an Adenosine A1−Receptor Antagonist, in Acute Heart Failure

(2010) Barry M. Massie et al.   NEW ENGLAND JOURNAL OF MEDICINE

Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design

(2010) Peter J. Barnes et al.   PULMONARY PHARMACOLOGY & THERAPEUTICS

Molecular Markers for Early Detection

(2010) Barbara K. Dunn et al.   SEMINARS IN ONCOLOGY

Identifying needs and opportunities for advancing translational research in cardiovascular disease

(2009) K. R. Sipido et al.   CARDIOVASCULAR RESEARCH

Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs

(2009) Janice Pogue et al.   Clinical Trials

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency

(2009) Jan Regnstrom et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Do we need to adjudicate major clinical events?

(2008) Christopher B Granger et al.   Clinical Trials

Genetically Elevated C-Reactive Protein and Ischemic Vascular Disease

(2008) Jeppe Zacho et al.   NEW ENGLAND JOURNAL OF MEDICINE