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Some remaining challenges regarding multiple endpoints in clinical trials

Statistics in medicine, 2017-12, Vol.36 (28), p.4441-4445

Snapinn, Steven

2017

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Effects of Losartan on Renal and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Nephropathy

The New England journal of medicine, 2001-09, Vol.345 (12), p.861-869

2001

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Albuminuria and cardiovascular risk in hypertensive patients with left ventricular hypertrophy: the LIFE study

Annals of internal medicine, 2003-12, Vol.139 (11), p.901

2003

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Risk Scores for Predicting Outcomes in Patients with Type 2 Diabetes and Nephropathy: The RENAAL Study

Clinical journal of the American Society of Nephrology, 2006-07, Vol.1 (4), p.761-767

2006

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University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding data and safety monitoring committees in clinical trials (morning panel session)

Clinical trials (London, England), 2018-08, Vol.15 (4), p.335-351

2018

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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 : the journal of the American Medical Association, 2004-07, Vol.292 (1), p.55

2004

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Does Albuminuria Predict Cardiovascular Outcomes on Treatment With Losartan Versus Atenolol in Patients With Diabetes, Hypertension, and Left Ventricular Hypertrophy?: The LIFE study

Diabetes care, 2006-03, Vol.29 (3), p.595-600

2006

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Comparison of Sample Size Requirements of Randomized and Historically Controlled Trials Based on Calibrated Error Rates

Statistics in biopharmaceutical research, 2023-01, Vol.15 (1), p.69-73

2023

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Assessment of futility in clinical trials

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2006-10, Vol.5 (4), p.273-281

2006

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The issue of multiplicity in noninferiority studies

Clinical trials (London, England), 2012-12, Vol.9 (6), p.730-735

2012

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Treatment effect measures under nonproportional hazards

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2023-01, Vol.22 (1), p.181-193

2023

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Comment on "Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group": The Test Statistic Should Estimate Some Reasonable Measure of Treatment Benefit

Statistics in biopharmaceutical research, 2023-04, Vol.15 (2), p.297-299

2023

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Proportion of treatment effect (PTE) explained by a surrogate marker

Statistics in medicine, 2003-11, Vol.22 (22), p.3449-3459

2003

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On the clinical meaningfulness of a treatment's effect on a time-to-event variable

Statistics in medicine, 2011-08, Vol.30 (19), p.2341-2348

2011

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Importance of baseline distribution of proteinuria in renal outcomes trials : Lessons from the reduction of endpoints in NIDDM with the angiotensin II antagonist losartan (RENAAL) study

Journal of the American Society of Nephrology, 2005-06, Vol.16 (6), p.1775-1780

2005

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Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials

Statistics in medicine, 2008-02, Vol.27 (3), p.382-391

2008

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Content Validity of HIT‐6 as a Measure of Headache Impact in People With Migraine: A Narrative Review

Headache, 2020-01, Vol.60 (1), p.28-39

2020

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Comment on "The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations"

Statistics in biopharmaceutical research, 2021-02, Vol.13 (1), p.40-42

2021

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Controlling the type 1 error rate in non-inferiority trials

Statistics in medicine, 2008-02, Vol.27 (3), p.371-381

2008

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Regression of electrocardiographic left ventricular hypertrophy during antihypertensive treatment and the prediction of major cardiovascular events

JAMA : the journal of the American Medical Association, 2004-11, Vol.292 (19), p.2343

2004

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Daprodustat and On-Treatment Cardiovascular Events in Chronic Kidney Disease. Reply

The New England journal of medicine, 2022-12, Vol.387 (26), p.2482

2022

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Daprodustat and On-Treatment Cardiovascular Events in Chronic Kidney Disease

The New England journal of medicine, 2022-12, Vol.387 (26), p.2481-2485

2022

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On-Treatment Cancer Safety Events With Daprodustat vs. Erythropoiesis-Stimulating Agents: Post Hoc Analyses of ASCEND-ND and ASCEND-D: SA-PO115

Journal of the American Society of Nephrology, 2022-11, Vol.33 (11S), p.631-631

2022

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Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents—post hoc analyses of the ASCEND-ND and ASCEND-D trials

Nephrology, dialysis, transplantation, 2023-07, Vol.38 (8), p.1890-1897

2023

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Some remaining challenges regarding multiple endpoints in clinical trials

Effects of Losartan on Renal and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Nephropathy

Albuminuria and cardiovascular risk in hypertensive patients with left ventricular hypertrophy: the LIFE study

Risk Scores for Predicting Outcomes in Patients with Type 2 Diabetes and Nephropathy: The RENAAL Study

University of Pennsylvania 10th annual conference on statistical issues in clinical trials: Current issues regarding data and safety monitoring committees in clinical trials (morning panel session)

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

Does Albuminuria Predict Cardiovascular Outcomes on Treatment With Losartan Versus Atenolol in Patients With Diabetes, Hypertension, and Left Ventricular Hypertrophy?: The LIFE study

Comparison of Sample Size Requirements of Randomized and Historically Controlled Trials Based on Calibrated Error Rates

Assessment of futility in clinical trials

The issue of multiplicity in noninferiority studies

Treatment effect measures under nonproportional hazards

Comment on "Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group": The Test Statistic Should Estimate Some Reasonable Measure of Treatment Benefit

Proportion of treatment effect (PTE) explained by a surrogate marker

On the clinical meaningfulness of a treatment's effect on a time-to-event variable

Importance of baseline distribution of proteinuria in renal outcomes trials : Lessons from the reduction of endpoints in NIDDM with the angiotensin II antagonist losartan (RENAAL) study

Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials

Content Validity of HIT‐6 as a Measure of Headache Impact in People With Migraine: A Narrative Review

Comment on "The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations"

Controlling the type 1 error rate in non-inferiority trials

Regression of electrocardiographic left ventricular hypertrophy during antihypertensive treatment and the prediction of major cardiovascular events

Daprodustat and On-Treatment Cardiovascular Events in Chronic Kidney Disease. Reply

Daprodustat and On-Treatment Cardiovascular Events in Chronic Kidney Disease

On-Treatment Cancer Safety Events With Daprodustat vs. Erythropoiesis-Stimulating Agents: Post Hoc Analyses of ASCEND-ND and ASCEND-D: SA-PO115

Predictors of cardiovascular events in patients with hypertension and left ventricular hypertrophy: the Losartan Intervention For Endpoint reduction in hypertension study

Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents—post hoc analyses of the ASCEND-ND and ASCEND-D trials

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