David DeMets

Q: What Schools Are Affiliated With David DeMets

David DeMets is affiliated with the following schools: University of Minnesota, University of Wisconsin–Madison

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David DeMets

Mathematics

#4725

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#6697

Historical Rank

Statistics

#266

World Rank

#325

Historical Rank

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Mathematics

Why Is David DeMets Influential?

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According to Wikipedia, David L. DeMets is an American biostatistician. DeMets earned a doctorate in biostatistics from the University of Minnesota in 1970, and completed his postdoctoral research at the National Institutes of Health in 1972, then joined the University of Wisconsin–Madison faculty in 1972. He was later named Max Halperin Professor of Biostatistics, and awarded emeritus status upon retirement in 2017.

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David DeMets's Published Works

Number of citations in a given year to any of this author's works

Total number of citations to an author for the works they published in a given year. This highlights publication of the most important work(s) by the author

Published Works

2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (2014) (6648)
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework (2001) (5642)
Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. (2004) (5153)
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in-Congestive Heart Failure (MERIT-HF) (1999) (4830)
Effect of carvedilol on survival in severe chronic heart failure. (2001) (3027)
Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. (2019) (2915)
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. (2013) (2552)
Discrete sequential boundaries for clinical trials (1983) (1979)
2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (2014) (1905)
2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (2014) (1904)
The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. (1984) (1890)
Fundamentals of Clinical Trials (1982) (1595)
The Wisconsin epidemiologic study of diabetic retinopathy. III. Prevalence and risk of diabetic retinopathy when age at diagnosis is 30 or more years. (1984) (1555)
Surrogate End Points in Clinical Trials: Are We Being Misled? (1996) (1517)
Interpretation of the evidence for the efficacy and safety of statin therapy (2016) (1290)
The Wisconsin Epidemiologic Study of Diabetic Retinopathy. VI. Retinal photocoagulation. (1987) (1272)
Effect of Carvedilol on the Morbidity of Patients With Severe Chronic Heart Failure: Results of the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study (2002) (1260)
Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer. (1992) (1132)
Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021) (1083)
2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults (2013) (1053)
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial (2018) (993)
Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group. (1996) (931)
The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. (1984) (786)
Methods for combining randomized clinical trials: strengths and limitations. (1987) (771)
2012 ACCF/AHA focused update incorporated into the ACCF/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. (2013) (590)
Reprint: 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. (2013) (583)
Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. (2013) (579)
Glycosylated hemoglobin predicts the incidence and progression of diabetic retinopathy. (1988) (578)
The Wisconsin Epidemiologic Study of Diabetic Retinopathy. IX. Four-year incidence and progression of diabetic retinopathy when age at diagnosis is less than 30 years. (1989) (487)
Interim analysis: the alpha spending function approach. (1994) (455)
A Dose-Dependent Increase in Mortality with Vesnarinone among Patients with Severe Heart Failure (1998) (427)
Randomized clinical trials. Perspectives on some recent ideas. (1976) (424)
Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop. (2001) (406)
Effects of tamoxifen on cardiovascular risk factors in postmenopausal women. (1991) (395)
The Wisconsin Epidemiologic Study of Diabetic Retinopathy. X. Four-year incidence and progression of diabetic retinopathy when age at diagnosis is 30 years or more. (1989) (363)
International, randomized, controlled trial of lamifiban (a platelet glycoprotein IIb/IIIa inhibitor), heparin, or both in unstable angina (1998) (351)
Secondary prevention after myocardial infarction: a review of long-term trials. (1982) (320)
A double blind study of the effects of zinc sulfate on taste and smell dysfunction (1976) (309)
Effects of tamoxifen therapy on lipid and lipoprotein levels in postmenopausal patients with node-negative breast cancer. (1990) (292)
Cyclooxygenase inhibition and cardiovascular risk. (2005) (278)
Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS recommendations): a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (2013) (277)
Clinical effects of endothelin receptor antagonism with bosentan in patients with severe chronic heart failure: results of a pilot study. (2005) (268)
Design and analysis of group sequential tests based on the type I error spending rate function (1987) (267)
2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. (2012) (256)
Is blood pressure a predictor of the incidence or progression of diabetic retinopathy? (1989) (237)
Fundamentals of Clinical Trials. (2nd ed.). (1987) (231)
Data Monitoring Committees in Clinical Trials: A Practical Perspective (2002) (229)
A trial to evaluate the effect of the sodium–glucose co‐transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA‐HF) (2019) (226)
A trial to evaluate the effect of the sodium–glucose co‐transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA‐HF) (2019) (226)
The Wisconsin epidemiologic study of diabetic retinopathy. XI. The incidence of macular edema. (1989) (225)
Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. (2022) (225)
Relation of ocular and systemic factors to survival in diabetes. (1989) (222)
A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. Vesnarinone Trial Investigators. (1999) (221)
Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial (2008) (220)
Factors Associated With Outcome in Heart Failure With Preserved Ejection Fraction: Findings From the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-PRESERVE) (2011) (211)
Reprint: 2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk. (2013) (211)
Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial (2021) (201)
Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction (2019) (195)
Prevalence of diabetes mellitus in southern Wisconsin. (1984) (190)
Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the Efficacy of Vasopressin antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST). (2005) (187)
Increasing the sample size when the unblinded interim result is promising (2004) (181)
The clinical features of submassive and massive pulmonary emboli. (1977) (181)
Group sequential methods for clinical trials with a one-sided hypothesis (1980) (175)
Data Monitoring Committees in Clinical Trials (2002) (175)
An aid to data monitoring in long-term clinical trials. (1982) (164)
Cardiac Resynchronization Therapy Reduces the Risk of Hospitalizations in Patients With Advanced Heart Failure: Results From the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) Trial (2009) (160)
Cardiovascular drug development: is it dead or just hibernating? (2015) (159)
The Beaver Dam Eye Study: the relation of age-related maculopathy to smoking. (1993) (156)
The randomized clinical trial: bias in analysis. (1981) (148)
The Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure (DAPA‐HF) trial: baseline characteristics (2019) (144)
History and physical examination in acute pulmonary embolism in patients without preexisting cardiac or pulmonary disease. (1981) (142)
Group sequential procedures: calendar versus information time. (1989) (139)
ACCF/AHA Clinical Practice Guideline Methodology Summit Report: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines (2013) (136)
The need for large-scale randomized evidence without undue emphasis on small trials, meta-analyses, or subgroup analyses. (2009) (134)
Asymmetric group sequential boundaries for monitoring clinical trials (1982) (132)
Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer. (2002) (131)
Her-2/neu overexpression and response to oophorectomy plus tamoxifen adjuvant therapy in estrogen receptor-positive premenopausal women with operable breast cancer. (2003) (130)
Dapagliflozin in heart failure with preserved and mildly reduced ejection fraction: rationale and design of the DELIVER trial (2021) (128)
Effects of low-dose oral enoximone administration on mortality, morbidity, and exercise capacity in patients with advanced heart failure: the randomized, double-blind, placebo-controlled, parallel group ESSENTIAL trials (2009) (123)
How informed is informed consent? The BHAT experience. (1981) (120)
The agonising negative trend in monitoring of clinical trials (1999) (119)
Retinopathy in Young-onset Diabetic Patients (1985) (119)
Monitoring of clinical trials: issues and recommendations. (1993) (117)
Challenges of subgroup analyses in multinational clinical trials: experiences from the MERIT-HF trial. (2001) (114)
Effects of dapagliflozin in DAPA-HF according to background heart failure therapy (2020) (114)
Computations for group sequential boundaries using the Lan-DeMets spending function method. (2000) (111)
Factors Associated With Outcome in Heart Failure With Preserved Ejection FractionClinical Perspective (2011) (109)
Introduction to Statistical Methods for Clinical Trials (2007) (103)
ACCF/AHA clinical practice guideline methodology summit report: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. (2013) (103)
Changing frequency of interim analysis in sequential monitoring. (1989) (103)
Estimation of normal ranges and cumulative proportions by transforming observed distributions to gaussian form. (1972) (101)
Lessons learned from recent cardiovascular clinical trials: Part I. (2002) (101)
Lessons learned from recent cardiovascular clinical trials: Part II. (2002) (94)
The clinical features of submassive and massive pulmonary emboli. (1977) (93)
Effect of amlodipine on mode of death among patients with advanced heart failure in the PRAISE trial. Prospective Randomized Amlodipine Survival Evaluation. (1998) (92)
Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF (2020) (89)
Approaches to monitoring the results of long-term disease prevention trials: Examples from the Women's Health Initiative (1996) (88)
Long-Term Effect of Endothelin Receptor Antagonism With Bosentan on the Morbidity and Mortality of Patients With Severe Chronic Heart Failure: Primary Results of the ENABLE Trials. (2017) (87)
Effect of amlodipine on the survival of patients with severe chronic heart failure due to a nonischemic cardiomyopathy: results of the PRAISE-2 study (prospective randomized amlodipine survival evaluation 2). (2013) (81)
Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis (2022) (80)
Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age (2019) (80)
Statistical association and causation: contributions of different types of evidence. (2011) (78)
Principles From Clinical Trials Relevant to Clinical Practice: Part II (2002) (78)
Statistical aspects of early termination in the beta-blocker heart attack trial (1984) (78)
Practical aspects in data monitoring: a brief review. (1987) (73)
Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF) (2020) (72)
Confidence intervals following group sequential tests in clinical trials. (1987) (70)
The Wisconsin Epidemiologic Study of Diabetic Retinopathy. A comparison of retinopathy in younger and older onset diabetic persons. (1985) (69)
Genomic surveillance to combat COVID-19: challenges and opportunities (2021) (66)
Sequential Comparison of Changes with Repeated Measurements Data (1991) (66)
Data Monitoring in Clinical Trials: A Case Studies Approach (2005) (64)
Phase I evaluation of a synthetic mutant of β-interferon (1985) (63)
Factors associated with visual outcome after photocoagulation for diabetic retinopathy. Diabetic Retinopathy Study Report #13. (1989) (63)
Sample sizes for long-term medical trial with time-dependent dropout and event rates. (1980) (62)
Data integrity. (2020) (62)
Machine Learning Algorithm Predicts Cardiac Resynchronization Therapy Outcomes: Lessons From the COMPANION Trial (2018) (61)
A historical perspective on clinical trials innovation and leadership: where have the academics gone? (2011) (60)
Toward protecting the safety of participants in clinical trials. (2003) (59)
Proteinuria in diabetes. (1988) (58)
Essential fatty acid deficiency in premature infants. (1988) (57)
Phase II trial of perillyl alcohol (NSC 641066) administered daily in patients with metastatic androgen independent prostate cancer (2003) (54)
Rationale, design, and organization of the metoprolol CR/XL randomized intervention trial in heart failure (MERIT-HF) (1997) (54)
Sample size determination for group sequential clinical trials with immediate response. (1992) (53)
The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. (1995) (52)
The Wisconsin Epidemiologic Study of Diabetic Retinopathy. VII. Diabetic nonproliferative retinal lesions. (1987) (52)
Principles from clinical trials relevant to clinical practice: Part I. (2002) (52)
Stopping guidelines vs stopping rules: a practitioner's point of view (1984) (52)
Use of logrank tests and group sequential methods at fixed calendar times. (1985) (52)
The alpha spending function approach to interim data analyses. (1995) (51)
Information and information fractions for design and sequential monitoring of clinical trials (1994) (50)
Inter-observer variation in refraction and visual acuity measurement using a standardized protocol. (1983) (50)
Simulation Studies on Increments of the Two-Sample Logrank Score Test for Survival Time Data, with Application to Group Sequential Boundaries (1982) (49)
Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial. (2022) (47)
A co-operative study for the detection of the carrier state of classic hemophilia. (1977) (47)
Estimating and reducing bias in group sequential designs with Gaussian independent increment structure (1997) (46)
Training of the next generation of biostatisticians: a call to action in the U.S. (2006) (44)
Data monitoring committees: Promoting best practices to address emerging challenges (2017) (44)
Futility approaches to interim monitoring by data monitoring committees (2006) (43)
Monitoring clinical trials: issues and controversies regarding confidentiality (2002) (42)
Blood pressure and hypertension in diabetes. (1985) (42)
Data Monitoring Committees - Expect the Unexpected. (2016) (42)
Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board (2007) (42)
Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial. (2020) (39)
An overview of sequential methods and their application in clinical trials (1984) (39)
Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER (2022) (39)
Conditional Bias of Point Estimates Following a Group Sequential Test (2004) (39)
Risk of chronic obstructive pulmonary disease. Collaborative assessment of the validity of the Tecumseh index of risk. (1984) (38)
Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape (2015) (37)
High‐dose influenza vaccine to reduce clinical outcomes in high‐risk cardiovascular patients: Rationale and design of the INVESTED trial☆☆ (2018) (37)
Estimation of a Simple Regression Coefficient in Samples Arising from a Sub-Sampling Procedure (1977) (36)
Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction (2020) (36)
An Institutional Review Board dilemma: responsible for safety monitoring but not in control (2006) (36)
Wisconsin Epidemiologic Study of Diabetic Retinopathy: XII. Relationship of C-Peptide and Diabetic Retinopathy (1990) (36)
A comparison of methods for correlated ordinal measures with ophthalmic applications. (1995) (36)
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus (2020) (36)
Challenges of Non–Intention-to-Treat Analyses (2019) (35)
Incentives for Clinical Trialists to Share Data. (2016) (35)
Reanalysis of some baboon descent data. (1976) (35)
Review of Draft FDA Adaptive Design Guidance (2010) (34)
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative (2017) (34)
Long-Term Effects of Flosequinan on the Morbidity and Mortality of Patients With Severe Chronic Heart Failure: Primary Results of the PROFILE Trial After 24 Years. (2017) (34)
On a model-based approach to estimating efficacy in clinical trials. (1994) (34)
Statistical issues in interpreting clinical trials (2004) (33)
A Randomized Trial of Aspirin at Clinically Relevant Doses and Nitric Oxide Formation in Humans (2010) (33)
Dapagliflozin reduces the risk of hyperkalaemia in patients with heart failure and reduced ejection fraction: a secondary analysis DAPA-HF (2020) (33)
Mastectomy and oophorectomy by menstrual cycle phase in women with operable breast cancer. (2002) (32)
The validity of a survey question to study diabetic retinopathy. (1986) (31)
Re: Mastectomy and Oophorectomy by Menstrual Cycle Phase in Women With Operable Breast Cancer (2002) (31)
Issues in the early termination of the aspirin component of the Physicians' Health Study. Data Monitoring Board of the Physicians' Health Study. (1991) (30)
Efficacy and safety of sodium–glucose co‐transporter 2 inhibition according to left ventricular ejection fraction in DAPA‐HF (2020) (30)
Estimating significance level and power comparisons for testing multiple endpoints in clinical trials. (2000) (29)
Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. V. Estimated biological variations in ionized calcium. (1971) (29)
Liability issues for data monitoring committee members (2004) (29)
Aspirin Increases Nitric Oxide Formation in Chronic Stable Coronary Disease (2013) (28)
Statistical issues relating to international differences in clinical trials. (2001) (28)
The independent statistician for data monitoring committees (2004) (27)
Sequential Rank Tests with Repeated Measurements in Clinical Trials (1992) (27)
A case report of data monitoring experience: the nocturnal oxygen therapy trial. (1982) (27)
Early methodological developments for clinical trials at the National Heart, Lung and Blood Institute. (1990) (27)
Design and Analysis of Group Sequential Clinical Trials with Multiple Primary Endpoints (2004) (26)
Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer (1992) (26)
Combined hepatic artery 5‐fluorouracil and irradiation of liver metastases. A randomized study (1989) (26)
The early termination of clinical trials: causes, consequences, and control. With special reference to trials in the field of arrhythmias and sudden death. Task Force of the Working Group on Arrhythmias of the European Society of Cardiology. (1994) (25)
Rationale and design of the enoximone clinical trials program. (2005) (25)
Urinary excretion of immunoreactive prostaglandin E: a circadian rhythm and the effect of posture. (1977) (24)
Statistical aspects of early termination in the beta-blocker heart attack trial. (1982) (24)
Distinctions between fraud, bias, errors, misunderstanding, and incompetence. (1997) (24)
Sequential monitoring of clinical trials with correlated responses (1996) (24)
A monitoring system to detect increased rates of cancer incidence. (1990) (23)
Training the Next Generation of Biostatisticians (1994) (22)
Data Monitoring Committees: Current issues (2018) (22)
The Role of an Independent Statistical Analysis Center in the Industry-Modified National Institutes of Health Model (2001) (21)
Evaluation metrics for biostatistical and epidemiological collaborations (2011) (21)
Dapagliflozin and new-onset type 2 diabetes in patients with chronic kidney disease or heart failure: pooled analysis of the DAPA-CKD and DAPA-HF trials (2021) (20)
The Randomization Process (2010) (20)
Outcomes of cardiac resynchronization therapy in patients with intermittent atrial fibrillation or atrial flutter in the COMPANION trial. (2017) (20)
The Monitored Atherosclerosis Regression Study (MARS). Design, methods and baseline results. (1992) (19)
Issues in regulatory guidelines for data monitoring committees (2004) (19)
Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials (2014) (19)
Understanding the functions and operations of data monitoring committees: Survey and focus group findings (2017) (19)
Insights from monitoring the CPCRA didanosine/zalcitabine trial. Terry Beirn Community Programs for Clinical Research on AIDS. (1995) (18)
When Can Intermediate Outcomes Be Used as Surrogate Outcomes? (2020) (18)
Early stopping in the two-sample problem for bounded random variables. (1982) (18)
Exact statistical inference for group sequential trials. (1991) (18)
An overview of group sequential methods in longitudinal clinical trials. (1998) (18)
Plain chest roentgenogram in patients with acute pulmonary embolism and no preexisting cardiac or pulmonary disease (1987) (18)
Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees. (2016) (17)
Dapagliflozin in Patients Recently Hospitalized With Heart Failure and Mildly Reduced or Preserved Ejection Fraction. (2022) (17)
Effect of Dapagliflozin in DAPA-HF According to Background Glucose-Lowering Therapy (2020) (16)
Introduction to Clinical Trials (2015) (16)
The data monitoring committee: how it operates and why. (1981) (16)
Some drop‐the‐loser designs for monitoring multiple doses (2010) (15)
The Wisconsin Epidemiologic Study of Diabetic Retinopathy: VIII. The incidence of retinal photocoagulation. (1988) (15)
Effects of intra- and inter-individual variation on distributions of single measurements. (1972) (15)
Clinical trials in the new millennium (2002) (15)
Lessons Learned and Insights Gained in the Design, Analysis, and Outcomes of the COMPANION Trial. (2016) (15)
Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis. (2003) (14)
Prevention: Aspirin in primary prevention needs individual judgements (2014) (13)
Data monitoring in clinical trials (2006) (13)
Doing more good than harm: need for a cease fire. (2009) (12)
An overview of group sequential methods in longitudinal clinical trials (2000) (12)
Exact permutation inference for two sample repeated measures data (1996) (12)
Adequate survival of red cells from units “undercollected” in citrate‐ phosphate‐dextrose‐adenine‐one (1984) (11)
Current development in clinical trials: issues old and new (2012) (11)
Guidelines for Statistical Analysis Plans. (2017) (11)
Patient-specific dosing of IIb/IIIa antagonists during acute coronary syndromes: Rationale and design of the PARAGON B study (2000) (11)
Fundamentals of Clinical Trials, 5th Edition (2020) (11)
Group sequential comparison of changes: ad-hoc versus more exact method. (1995) (11)
Bias and trials stopped early for benefit. (2010) (10)
Randomized Trial of Plaque-Identifying Toothpaste: Decreasing Plaque and Inflammation. (2017) (10)
Academic perspectives on the United States Food and Drug Administration's guidance for industry on diabetes mellitus. (2010) (10)
Achieving effective informed oversight by DMCs in COVID clinical trials (2020) (10)
The Data Monitoring Experience in the Cardiac Arrhythmia Suppression Trial: The Need to Be Prepared Early (2006) (9)
Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability (2017) (9)
Approached to monitoring the results of long-term disease prevention trials: examples from the Women's Health Initiative. (1996) (9)
Efficacy and Safety of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Age: The DELIVER Trial (2022) (9)
The Data and Safety Monitoring Committee: Some final thoughts. (2001) (9)
Basic Study Design (2015) (9)
Some Thoughts on Challenges for Noninferiority Study Designs (2012) (9)
Surrogate disease markers as substitutes for chronic disease outcomes in studies of diet and chronic disease relations. (2017) (9)
271-OR: ADA Presidents’ Select Abstract: Effect of Dapagliflozin on the Incidence of Diabetes: A Prespecified Exploratory Analysis from DAPA-HF (2020) (8)
Mindfulness with paced breathing reduces blood pressure. (2020) (8)
The Addition of a Defibrillator to Resynchronization Therapy Decreases Mortality in Patients With Nonischemic Cardiomyopathy. (2021) (8)
Type 2 diabetes mellitus development programs in the new regulatory environment with cardiovascular safety requirements (2015) (8)
Where the Jobs are: A Study of Amstat News Job Advertisements (1998) (8)
Relationships Between Data Monitoring Committees (2000) (8)
ON THE BIAS OF ESTIMATION OF A BROWNIAN MOTION DRIFT FOLLOWING GROUP SEQUENTIAL TESTS (2003) (8)
Counting events in clinical trials. (1980) (8)
Assessment of Health-Related Quality of Life (2010) (8)
Methodological issues in AIDS clinical trials. Data monitoring and sequential analysis--an academic perspective. (1990) (7)
Design of phase II trials in congestive heart failure. (2000) (7)
Updates on Hydroxychloroquine in Prevention and Treatment of COVID-19 (2021) (6)
Risk of Chronic Obstructive Pulmonary Disease (2015) (6)
Further Comments on the Alpha-Spending Function (2009) (6)
Statistics and ethics in medical research (1999) (6)
Statistical Methods Used in Interim Monitoring (2015) (6)
Design issues for a breast cancer chemoprevention trial. (1991) (6)
Data Collection and Quality Control (2015) (6)
Conditional and Unconditional Confidence Intervals Following a Group Sequential Test (2006) (5)
Phase I evaluation of a synthetic mutant of beta-interferon. (1985) (5)
The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta‐analysis of COMPANION and CARE‐HF (2022) (5)
Estimation following group sequential tests with repeated measurements data (1999) (5)
The role of surrogate outcome measures in evaluating medical devices. (2000) (5)
Monitoring Response Variables (2010) (5)
Issues in Data Analysis (2010) (5)
The Wisconsin Network for Health Research (WiNHR): a statewide, collaborative, multi-disciplinary, research group. (2009) (4)
Assessment and Reporting of Harm (2015) (4)
Monitoring Emerging Data From the COMPASS Trial of an Antithrombotic Agent. (2019) (4)
Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial (2022) (4)
Data and safety monitoring boards of randomized trials: evolving principles and practical suggestions (2011) (4)
Assessing and Reporting Adverse Events (2010) (4)
Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of DMCs (2014) (4)
Recruitment experience in the Nocturnal Oxygen Therapy Trial. (1987) (4)
Bias and Trials Stopped Early for Benefit. Authors' reply (2010) (4)
Sequential Designs in Clinical Trials (1998) (4)
Marketing Drugs Too Early in Testing (2006) (4)
Statistical, Philosophical and Ethical Issues in Data Monitoring (2003) (4)
What is the Question (1996) (3)
ASPIRIN IN PRIMARY PREVENTION: NEEDS INDIVIDUAL JUDGMENTS. (2020) (3)
Surrogate endpoints. (1997) (3)
Data monitoring committee interim reports: We must get there soon! (2021) (3)
The independent statistician model: How well is it working? (2018) (3)
Lan-DeMets Alpha-Spending Function (2014) (3)
BIAS CORRECTION IN GROUP SEQUENTIAL ANALYSIS WITH CORRELATED DATA (1999) (3)
ASPIRIN FOR PRIMARY PREVENTION IN PATIENTS WITH TYPE 2 DIABETES. (2018) (2)
Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions (2022) (2)
Discussion on "Statistical Issues Arising in the Women's Health Initiative" (2005) (2)
The Role and Potential of Surrogate Outcomes in Clinical Trials: Have We Made Any Progress in the Past Decade? (2013) (2)
Remembrances of Max Halperin. (1990) (2)
Data Monitoring Committees (2005) (2)
Can Large Simple Trials Help Us Understand When and How to Use Generic Drugs for Uncommon Diseases? (2013) (2)
Alpha‐Spending Function (2014) (2)
HEART FAILURE WITH PRESERVED EJECTION FRACTION: MORTALITY RISK POST FIRST HOSPITALIZATION - DATA FROM I-PRESERVE (2010) (2)
NHLBI clinical trials workshop: an executive summary (2012) (2)
Re: The influence of menstrual cycle phase on surgical treatment of primary breast cancer: have we made any progress over the past 13 years? (2002) (2)
Reporting and Interpreting of Results (2010) (2)
The effect of dapagliflozin across the spectrum of baseline risk: a post-hoc analysis of DAPA-HF (2020) (2)
9. Statins in the treatment and prevention of cardiovascular diseases (2016) (2)
Data monitoring committees: history and their future (2013) (2)
COVID-19 control in the United States: the case for masking. (2021) (2)
Establishing and Maintaining Research Integrity at Academic Institutions: Challenges and Opportunities. (2020) (2)
The Influence of Biostatistics at the National Heart, Lung, and Blood Institute (2015) (2)
Recruitment of Study Participants (2015) (2)
Bayesian Approaches to Randomized Trails - Discusion (1994) (2)
Can early stopping procedures impact significantly on the efficiency of clinical trials without serious loss of information? (1984) (2)
Cardiac Resynchronization Therapy Reduces the Risk of Hospitalizations in Patients With Advanced Heart Failure (2009) (2)
Regulatory Considerations for the Operation of Data Monitoring Committees (2003) (1)
1112-P: Does Background T2D Therapy Modify the Benefits of Dapagliflozin in Heart Failure? Analysis of the DAPA-HF Trial (2020) (1)
Impact of Degree of Left Ventricular Remodeling on Clinical Outcomes From Cardiac Resynchronization Therapy. (2019) (1)
Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial (2023) (1)
Alternatives to Intention-to-Treat Analyses-Reply. (2019) (1)
Confidence Intervals Following Group Sequential Tests in Clinical Trails with Multivariate Observations (2002) (1)
The future of clinical trials: A panel discussion (2012) (1)
Primary care providers should prescribe aspirin to prevent cardiovascular disease based on benefit−risk ratio, not age (2021) (1)
Discussion: The role, position, and function of the FDA-The past, present, and future. (2017) (1)
Low-dose enteric-coated aspirin does not inhibit thromboxane B2 and prostaglandin E2: data-derived hypothesis formulation (2012) (1)
Appendix A: The Data Monitoring Committee Charter (2003) (1)
Abstract 851: Usual Doses of Aspirin Markedly Increase Nitric Oxide Formation in Humans (2009) (1)
Further Comments on the Alpha Spending Function (2009) (1)
Cardiology/American Heart Association Task Force on Practice Guidelines and 2011 ACCF/AHA/HRS Recommendations): A Report of the American College of Management of Patients With Atrial Fibrillation (Compilation of 2006 ACCF/AHA/ESC (2014) (1)
Monitoring Committee Structure and Function (2015) (1)
Data Monitoring Committee Interactions with Other Trial Components or Related Groups (2003) (1)
Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability (2016) (1)
Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods (2006) (1)
Correlation between Oral Health and Systemic Inflammation (COHESION): A Randomized Pilot Follow Up Trial of a Plaque Identifying Toothpaste. (2020) (1)
Discussion: M K B Parmar and David Machin, monitoring clinical trials; Experience of, and proposals under consideration by the Cancer Therapy Committee of the British Medical Research Council (1993) (1)
Updates for Health Providers on Monoclonal Antibodies for COVID-19: Less Promising Adjunct and Never an Alternative to Vaccinations (2022) (0)
HER-2/neu Overexpression a nd R esponse t o O ophorectomy Plus T amoxifen A djuvant T herapy i n E strogen R eceptor- Positive P remenopausal W omen W ith O perable B reast C ancer (2003) (0)
Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint (2006) (0)
Fraud and misconduct in medical research. Stephen Lock and Frank Wells (eds), London, British Medical Journal, 1993. no. of pages: XI + 202. price: £12.95. ISBN: 0-7279-0757-3 (1994) (0)
No, Not Another IRB (2003) (0)
Author Correction: Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial. (2023) (0)
Introduction to Case Studies Showing Harmful Effects of the Intervention (2006) (0)
Abstract 3192: Obesity and Its Relationship to Adverse Cardiovascular Outcomes in Older Patients With Heart Failure and Preserved Ejection Fraction in the I-PRESERVE Trial (2009) (0)
The end of the beginning: A commentary on ‘Evaluation metrics for biostatistical and epidemiological collaborations’: A rejoinder (2011) (0)
Responsibilities of the Data Monitoring Committee and Motivating Illustrations (2003) (0)
University of Wisconsin IAIMS planning: organizational challenges within a faculty governance model (2000) (0)
Monitoring Committees: Why and How (2006) (0)
Experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale adaptive platform randomised trial of treatments for patients hospitalised with COVID-19 (2022) (0)
Commentary on Anand et al. (2011) (0)
Wisconsin IAIMS: Towards a Regional Health IT Architecture (2001) (0)
Estimationof NormalRangesand CumulativeProportions byTransformingObservedDistributionsto GaussianForm (2004) (0)
74. Surrogate Endpoints (2014) (0)
The challenges of data safety monitoring for a pragmatic study: Lessons from the ADAPTABLE study. (2022) (0)
Effects of lntra- and Inter-IndividualVariation on Distributionsof Single Measurements (2004) (0)
A likelihood ratio test for unequal shared environmental variance in twin studies. (1978) (0)
The Data Monitoring Committee: A Collective or a Collection? (2023) (0)
Introduction to Mixed Modelling: Beyond Regression and Analysis of Variance by GALWEY, N. W.Linear Mixed Models: A Practical Guide Using Statistical Software by WEST, B. T., WELCH, K. B., and GALECKI, A. T (2008) (0)
Monitoring multiple doses in a combined phase II / IlI clinical trial : Multivariate test procedures (2014) (0)
Introduction to Case Studies With Special Issues (2006) (0)
[Evaluating Therapeutic Interventions: Some Issues and Experiences]: Comment (1992) (0)
Determining When a Data Monitoring Committee is Needed (2003) (0)
University of Pennsylvania 5th annual conference on statistical issues in clinical trials: Emerging statistical issues in biomarker validation (Morning Session) (2013) (0)
Data Monitoring Committee Meetings (2003) (0)
Secondary Trials After Myocardial Infarction: A Review (1983) (0)
Moving Toward Clarity, or Clouding the View? (2011) (0)
90244353 Effects of tamoxifen therapy on lipid and lipoprotein levels in postmenopausal patients with node-negative breast cancer (1991) (0)
"(2006), A16. Brody, Baruch A. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press, 1998. Capron, Alexander M." Experimentation with Human Beings: Light or Only Shadows?" Yale Journal of Health Policy, Law and (2008) (0)
The effect of dapagliflozin in patients with HFrEF and COPD: a post-hoc analysis of DAPA-HF (2020) (0)
92103997 Effects of tamoxifen on bone mineral density in postmenopausal women with breast cancer (1992) (0)
Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures (2018) (0)
Data and Safety Monitoring (2021) (0)
Randomised controlled clinical trials: C.J. Bulpitt Martinus Nijhoff Publishers, The Hague, 1983, 261 pp., $52.00 (1985) (0)
Book Reviews (2007) (0)
Confidentiality Issues Relating to the Data Monitoring Committee (2003) (0)
Chapter 4 – Principles of Data and Safety Monitoring Boards in Randomized Trials (2004) (0)
Composition of a Data Monitoring Committee (2003) (0)
The Nocturnal Oxygen Therapy Trial Data Monitoring Experience: Problem With Reporting Lags (2006) (0)
Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest (2003) (0)
Abstract 1600: Cardiac Resynchronization Therapy Reduces the Risk of Hospitalizations in Patients with Advanced Heart Failure - Results From the COMPANION Trial (2007) (0)
IN GROUP SEQUENTIAL ANALYSIS WITH CORRELATED DATA (2003) (0)
Introduction to Case Studies Showing Benefit from the Intervention (2006) (0)
COMMENTARY Relationships Between Data Monitoring Committees (2000) (0)
Updates on Aspirin in Primary Prevention of Cardiovascular Disease Create New Clinical and Policy Challenges (2021) (0)
Monitoring clinical trials in infectious diseases (2021) (0)
Mueller et al TIMI II Subgroup Analyses : Predictors of Early Events 1255 factors for early death in patients with AMI treated with thrombolytic therapy . The Thrombolysis in Myocardial Infarction ( TIMI ) phase (2005) (0)

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