Endpoint Determination

• 

  Subject Areas on Research

  • 'Smooth' inference for survival functions with arbitrarily censored data. 
  • 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). 
  • 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). 
  • 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). 
  • 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. 
  • 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. 
  • A Critical Appraisal of Short-Term End Points in Acute Heart Failure Clinical Trials. 
  • A comparison of least squares and conditional maximum likelihood estimators under volume endpoint censoring in tumor growth experiments. 
  • A general formulation for a one-sided group sequential design. 
  • A global rank end point for clinical trials in acute heart failure. 
  • A global ranking approach to end points in trials of mechanical circulatory support devices. 
  • A hybrid Bayesian adaptive design for dose response trials. 
  • A longitudinal trial comparing chloroquine as monotherapy or in combination with artesunate, azithromycin or atovaquone-proguanil to treat malaria. 
  • A novel test to compare two treatments based on endpoints involving both nonfatal and fatal events. 
  • A phase I surrogate endpoint study of SU6668 in patients with solid tumors. 
  • A randomized trial comparing the efficacy and safety of imiglucerase (Cerezyme) infusions every 4 weeks versus every 2 weeks in the maintenance therapy of adult patients with Gaucher disease type 1. 
  • A tale of two trials: a comparison of the post-acute coronary syndrome lipid-lowering trials A to Z and PROVE IT-TIMI 22. 
  • Abciximab survival advantage following percutaneous coronary intervention is predicted by clinical risk profile. 
  • Adalimumab in Active and Inactive, Non-Infectious Uveitis: Global Results from the VISUAL I and VISUAL II Trials. 
  • Alopecia areata investigational assessment guidelines--Part II. National Alopecia Areata Foundation. 
  • An evidence-based approach to perioperative nutrition support in the elective surgery patient. 
  • An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. 
  • Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials. 
  • Analysis of time-to-event data with nonuniform patient entry and loss to follow-up under a two-stage seamless adaptive design with weibull distribution. 
  • Analysis strategies for adaptive designs with multiple endpoints. 
  • Application of the parallel line assay to assessment of biosimilar products based on binary endpoints. 
  • Applying novel methods to assess clinical outcomes: insights from the TRILOGY ACS trial. 
  • Assessment of myocardial infarction by cardiac magnetic resonance imaging and long-term mortality. 
  • Assessment of myocardial scarring improves risk stratification in patients evaluated for cardiac defibrillator implantation. 
  • Azimilide for the treatment of atrial fibrillation, atrial flutter, and paroxysmal supraventricular tachycardia: results of a randomized trial and insights on the concordance of symptoms and recurrent arrhythmias. 
  • Benefit of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes and troponin t-positive status: the paragon-B troponin T substudy. 
  • Benefits and risks of abciximab use in primary angioplasty for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial. 
  • Benefits, challenges and obstacles of adaptive clinical trial designs. 
  • Biomarkers and Surrogate Endpoints: Lessons Learned From Glaucoma. 
  • Biomarkers and correlative endpoints for immunotherapy trials. 
  • Biomarkers and surrogate endpoints in glaucoma clinical trials. 
  • Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum. 
  • Characterization of cardiovascular clinical events and impact of event adjudication on the treatment effect of darapladib versus placebo in patients with stable coronary heart disease: Insights from the STABILITY trial. 
  • Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium. 
  • Clinical endpoints for drug development in prostate cancer. 
  • Clinical studies of angiogenesis inhibitors: the University of Texas MD Anderson Center Trial of Human Endostatin. 
  • Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium. 
  • Clinical trials of pharmacological therapies in acute heart failure syndromes: lessons learned and directions forward. 
  • Comments on concurrent and adjuvant chemotherapy for nasopharyngeal carcinoma: a mist of mysterious results. 
  • Comparison of omapatrilat and enalapril in patients with chronic heart failure: the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE). 
  • Comparison of one-year outcomes following coronary artery stenting in diabetic versus nondiabetic patients (from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy [ESPRIT] Trial). 
  • Comparison of outcomes of patients with myocardial infarction when living alone versus those not living alone. 
  • Composite End Points in Acute Heart Failure Research: Data Simulations Illustrate the Limitations. 
  • Composite End Points in Clinical Research: A Time for Reappraisal. 
  • Connecting genetic risk to disease end points through the human blood plasma proteome. 
  • Cystatin C and estimated glomerular filtration rate as predictors for adverse outcome in patients with ST-elevation and non-ST-elevation acute coronary syndromes: results from the Platelet Inhibition and Patient Outcomes study. 
  • Cytokine profiling for prediction of symptomatic radiation-induced lung injury. 
  • Death: The Simple Clinical Trial Endpoint. 
  • Decade-Long Profile of Imaging Biomarker Use in Ophthalmic Clinical Trials. 
  • Defining heart failure end points in ST-segment elevation myocardial infarction trials: integrating past experiences to chart a path forward. 
  • Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access. 
  • Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. 
  • Designing phase II studies in cancer with time-to-event endpoints. 
  • Designs for randomized phase II clinical trials with two treatment arms. 
  • Determination of the falloff constant (k(f)) from modeling biochemical marker release: a new variable for discriminating therapies. 
  • Determining the efficacy of antiplatelet therapies for the individual: lessons from clinical trials. 
  • Determining the most appropriate components for a composite clinical trial outcome. 
  • Do cardiac troponins provide prognostic insight in hemodialysis patients? 
  • Effect of abciximab on angiographic complications during percutaneous coronary stenting in the Evaluation of Platelet IIb/IIIa Inhibition in Stenting Trial (EPISTENT). 
  • Effect of antihypertensive therapy on incident stroke in cohorts with prehypertensive blood pressure levels: a meta-analysis of randomized controlled trials. 
  • Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study. 
  • Efficacy and safety of extended-release venlafaxine in the treatment of generalized anxiety disorder in children and adolescents: two placebo-controlled trials. 
  • Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank. 
  • End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--Alliance for Clinical Trials in Oncology--International Society Of Geriatric Oncology position article. 
  • End points for clinical trials in acute heart failure syndromes. 
  • Endpoints for clinical trials testing treatment of acute graft-versus-host disease: a joint statement. 
  • Enhanced response to enzyme replacement therapy in Pompe disease after the induction of immune tolerance. 
  • Established and Emerging Roles of Biomarkers in Heart Failure Clinical Trials. 
  • Estimating Clinical Trial Bleeding Events Using Electronic Health Record Data. 
  • Estimating suicidality as an outcome measure in clinical trials of suicide in schizophrenia. 
  • Ethics and equipoise: rationale for a placebo-controlled study design of platelet glycoprotein IIb/IIIa inhibition in coronary intervention. 
  • Evaluating treatment efficacy by multiple end points in phase II acute heart failure clinical trials: analyzing data using a global method. 
  • Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint. 
  • Evaluation of progressive neuroretinal rim loss as a surrogate end point for development of visual field loss in glaucoma. 
  • Four phases of intravenous fluid therapy: a conceptual model. 
  • Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials. 
  • Growth as a part of the composite endpoint in paediatric antiretroviral clinical trials. 
  • Hemoglobin and N-terminal pro-brain natriuretic peptide: Independent and synergistic predictors of mortality in patients with acute heart failure Results from the International Collaborative of NT-proBNP (ICON) Study. 
  • Hospitalization for Recently Diagnosed Versus Worsening Chronic Heart Failure: From the ASCEND-HF Trial. 
  • How can modeling best contribute to the assessment of secondary stroke prevention strategies? 
  • Hypocaloric compared with eucaloric nutritional support and its effect on infection rates in a surgical intensive care unit: a randomized controlled trial. 
  • ISCHEMIA: Establishing the Primary End Point. 
  • Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. 
  • Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. 
  • Impact of weighted composite compared to traditional composite endpoints for the design of randomized controlled trials. 
  • Implantable cardioverter defibrillator in high-risk long QT syndrome patients. 
  • Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review. 
  • Implementing core outcomes in kidney disease: report of the Standardized Outcomes in Nephrology (SONG) implementation workshop. 
  • Incidence of severe Plasmodium falciparum malaria as a primary endpoint for vaccine efficacy trials in Bandiagara, Mali. 
  • Increased Risk of Severe Hypoglycemic Events Before and After Cardiovascular Outcomes in TECOS Suggests an At-Risk Type 2 Diabetes Frail Patient Phenotype. 
  • Inference on treatment effects from a randomized clinical trial in the presence of premature treatment discontinuation: the SYNERGY trial. 
  • Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points: Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure). 
  • Influence of obesity on surgical regional anesthesia in the ambulatory setting: an analysis of 9,038 blocks. 
  • Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial. 
  • Interpreting measures of treatment effect in cancer clinical trials. 
  • Latent-model robustness in joint models for a primary endpoint and a longitudinal process. 
  • Lessons learned from recent cardiovascular clinical trials: Part I. 
  • Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure. 
  • Long-term intraocular pressure fluctuations and risk of conversion from ocular hypertension to glaucoma. 
  • Making genuine progress against metastatic breast cancer. 
  • Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements. 
  • Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer. 
  • Metoprolol and coronary artery bypass grafting surgery: does intraoperative metoprolol attenuate acute beta-adrenergic receptor desensitization during cardiac surgery? 
  • Metrics to assess the quantity of antibiotic use in the outpatient setting: a systematic review followed by an international multidisciplinary consensus procedure. 
  • Monitoring liver safety in drug development: the GSK experience. 
  • More sensitive assays for better drug resistance prediction? 
  • Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids-DOTT trial): pilot/feasibility phase findings. 
  • Multicenter study of acetaminophen hepatotoxicity reveals the importance of biological endpoints in genomic analyses. 
  • Multiple testing of treatment-effect-modifying biomarkers in a randomized clinical trial with a survival endpoint. 
  • Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer. 
  • Objective outcome measures: Collecting meaningful data on alopecia areata. 
  • Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis. 
  • On Enrichment Strategies for Biomarker Stratified Clinical Trials. 
  • On Two-stage Seamless Adaptive Design in Clinical Trials. 
  • One-year experience with intravenous treprostinil for pulmonary arterial hypertension. 
  • Opioid-volatile anesthetic synergy: a response surface model with remifentanil and sevoflurane as prototypes. 
  • Outcomes of patients with acute coronary syndromes and prior coronary artery bypass grafting: results from the platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial. 
  • Outcomes research in cardiovascular imaging: report of a workshop sponsored by the National Heart, Lung, and Blood Institute. 
  • Outcomes-Based CV Imaging Research Endpoints and Trial Design: From Pixels to Patient Satisfaction. 
  • P-value calculation for multistage phase II cancer clinical trials. 
  • Patient-centered outcomes composites: a glimpse of the future. 
  • Patients with acute coronary syndromes without persistent ST elevation undergoing percutaneous coronary intervention benefit most from early intervention with protection by a glycoprotein IIb/IIIa receptor blocker. 
  • Patterns of platelet response in idiopathic TTP/HUS: frequency of declining platelet counts with plasma exchange and the recognition and significance of a pseudo refractory state. 
  • Peer-assessed outcomes in the multimodal treatment study of children with attention deficit hyperactivity disorder. 
  • Permutation criteria to evaluate multiple clinical endpoints in a proof-of-concept study: lessons from Pre-RELAX-AHF. 
  • Phase I/II study of mocetinostat in combination with gemcitabine for patients with advanced pancreatic cancer and other advanced solid tumors. 
  • Phase II cancer clinical trials for biomarker-guided treatments. 
  • Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator. 
  • Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: a meta-analysis of all major randomised clinical trials. 
  • Predictive probability of serum prostate-specific antigen for prostate cancer: an approach using Bayes rule. 
  • Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic renal cell carcinoma. 
  • Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. 
  • Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. 
  • Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis: a consensus effort from the multinational interdisciplinary working group for uveitis in childhood. 
  • Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition. 
  • Prospective randomized study of mode switching in a clinical trial of pacemaker therapy for sinus node dysfunction. 
  • Prostate-specific antigen endpoints in hormone-refractory prostate cancer. 
  • Quetiapine as monotherapy for social anxiety disorder: a placebo-controlled study. 
  • Rationale and design of the pilot randomized study of nesiritide versus dobutamine in heart failure (PRESERVD-HF). 
  • Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure. 
  • Recent developments in therapeutic cancer vaccines. 
  • Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank. 
  • Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points. 
  • Relationship of T2-Weighted MRI Myocardial Hyperintensity and the Ischemic Area-At-Risk. 
  • Reliability of the triple-timed up-and-go test. 
  • Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial. 
  • Reply: idiopathic pulmonary fibrosis: perspectives on clinically meaningful primary endpoints in phase 3 clinical trials. 
  • Review of the accumulated PLATO documentation supports reliable and consistent superiority of ticagrelor over clopidogrel in patients with acute coronary syndrome: Commentary on: DiNicolantonio JJ, Tomek A, Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: serious concerns over the reliability of the PLATO trial, International Journal of Cardiology, 2013. 
  • Scientific factors and current issues in biosimilar studies. 
  • Seeking the optimal aspirin dose in acute coronary syndromes. 
  • Serum CA19-9 response as a surrogate for clinical outcome in patients receiving fixed-dose rate gemcitabine for advanced pancreatic cancer. 
  • Slowed ST segment recovery despite early infarct artery patency in patients with Q waves at presentation with a first acute myocardial infarction. Implications of initial Q waves on myocyte reperfusion. 
  • Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. 
  • Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. 
  • Statistical analysis for two-stage seamless design with different study endpoints. 
  • Statistical methods in translational medicine. 
  • Steroid-Responsive Acute Rejection Should Not Be the End Point for Immunosuppressive Trials. 
  • Stiffness After Pan-Lumbar Arthrodesis for Adult Spinal Deformity Does Not Significantly Impact Patient Functional Status or Satisfaction Irrespective of Proximal Endpoint. 
  • Study of the biologic effects of lapatinib, a reversible inhibitor of ErbB1 and ErbB2 tyrosine kinases, on tumor growth and survival pathways in patients with advanced malignancies. 
  • Successful Translation of Fluorescence Navigation During Oncologic Surgery: A Consensus Report. 
  • Surgical perspectives in gastrointestinal disease: a study of quality of life outcomes in esophageal, pancreatic, colon, and rectal cancers. 
  • Systematic review and consensus definitions for standardised endpoints in perioperative medicine: postoperative cancer outcomes. 
  • Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine (StEP) initiative: infection and sepsis. 
  • Testing homogeneity of two zero-inflated Poisson populations. 
  • Tests for inter-subject and total variabilities under crossover designs. 
  • The American College of Rheumatology response criteria for proliferative and membranous renal disease in systemic lupus erythematosus clinical trials. 
  • The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). 
  • The National Lung Screening Trial: overview and study design. 
  • The challenge of systematic reviews of diagnostic and staging studies in cancer. 
  • The clinician as investigator: participating in clinical trials in the practice setting: Appendix 1: fundamentals of study design. 
  • The clinician as investigator: participating in clinical trials in the practice setting: Appendix 2: statistical concepts in study design and analysis. 
  • The imaging viewpoint: how imaging affects determination of progression-free survival. 
  • The impact of arrhythmias in acute heart failure. 
  • The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. 
  • The rate of structural change: the confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study. 
  • Thrombin-specific anticoagulation with bivalirudin versus heparin in patients receiving fibrinolytic therapy for acute myocardial infarction: the HERO-2 randomised trial. 
  • Translational toxicology: a developmental focus for integrated research strategies. 
  • Trends in Heart Failure Clinical Trials From 2001-2012. 
  • Troponin T levels and risk of 30-day outcomes in patients with the acute coronary syndrome: prospective verification in the GUSTO-IV trial. 
  • Understanding prognostic benefits of exercise and antidepressant therapy for persons with depression and heart disease: the UPBEAT study--rationale, design, and methodological issues. 
  • Undertaking positive control studies as part of developmental neurotoxicity testing: a report from the ILSI Research Foundation/Risk Science Institute expert working group on neurodevelopmental endpoints. 
  • Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. 
  • Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. 
  • Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. 
  • Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. 
  • Use of alternative methodologies for evaluation of composite end points in trials of therapies for critical limb ischemia. 
  • Visual Function Metrics in Early and Intermediate Dry Age-related Macular Degeneration for Use as Clinical Trial Endpoints. 
  • [Comparative prognostic value of plasma and urinary N-terminal pro-B-type natriuretic peptide in patients with acute destabilized heart failure]. 
• 

  Keywords of People

  • Halabi, Susan, Professor of Biostatistics and Bioinformatics, Biostatistics & Bioinformatics
  • Milano, Carmelo Alessio, Professor of Surgery, Surgery, Cardiovascular and Thoracic Surgery
  • Nielsen, Karen Cristina, Associate Professor of Anesthesiology, Anesthesiology, Ambulatory
  • O'Connor, Christopher Michael, Richard Sean Stack, M.D. / Guidant Foundation Distinguished Professor of Cardiology, Medicine, Clinical Pharmacology
  • Patz Jr., Edward F., James and Alice Chen Distinguished Professor of Radiology, Pathology
  • Sullivan, Daniel Carl, Professor Emeritus of Radiology, Radiology
  • Swaminathan, Madhav, Professor of Anesthesiology, Anesthesiology, Cardiothoracic