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Lista de obras de Janet Wittes

A phase I/IIa safety, immunogenicity, and efficacy bridging randomized study of a two-dose regimen of liquid and lyophilized formulations of the candidate malaria vaccine RTS,S/AS02A in malaria-naïve adults

artículo científico publicado en 2007

A randomized, double-blind, double-dummy, controlled dose comparison of thalidomide for treatment of erythema nodosum leprosum.

artículo científico publicado en 2005

Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies

artículo científico publicado en 2015

Assessing correlates of protection in vaccine trials

artículo científico publicado en 2014

Bardoxolone methyl and kidney function in CKD with type 2 diabetes

artículo científico publicado en 2011

Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease

artículo científico publicado en 2013

Baseline Characteristics and Early Blood Pressure Control in the CONVINCE Trial.

artículo científico publicado en 2001

Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial

artículo científico publicado en 2013

Bias and trials stopped early for benefit.

artículo científico publicado en 2010

Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya

artículo científico publicado en 2009

Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis

artículo científico publicado en 2008

Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval

artículo científico publicado en 2007

Celecoxib for the prevention of colorectal adenomatous polyps

artículo científico publicado en 2006

Celecoxib for the prevention of sporadic colorectal adenomas

artículo científico publicado en 2006

Clinical trials must cope better with multiplicity

artículo científico publicado el 1 de noviembre de 2012

Comment on paper by Crowe et al.

artículo científico publicado en 2009

Commentary on 'Measurement in clinical trials: a neglected issue for statisticians?'.

artículo científico publicado en 2009

Commentary on Randomization: The forgotten component of the randomized clinical trial

artículo científico publicado en 2019

Comments on the FDA Draft Guidance on Adaptive Designs

artículo científico publicado el 1 de noviembre de 2010

Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC)

scientific article published on 04 June 2020

Correlates, surrogates, and vaccines.

artículo científico publicado en 2007

Cost-effectiveness of gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol: the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial

artículo científico publicado en 2002

Discussion of Paper by Korn and Freidlin

artículo científico publicado el 1 de marzo de 2011

Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure

artículo científico publicado en 2017

Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas

artículo científico publicado en 2006

Efficacy of live attenuated influenza vaccine in children: A meta-analysis of nine randomized clinical trials.

artículo científico publicado en 2008

Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study

artículo científico publicado en 2003

Experience collecting interim data on mortality: an example from the RALES study

artículo científico publicado en 2001

First-line treatment of metastatic renal cell carcinoma after COMPARZ and PISCES.

artículo científico

Forming your phase III trial's data and safety monitoring board: a perspective on safety

artículo científico publicado en 2004

Immunity to influenza in older adults with chronic obstructive pulmonary disease

artículo científico publicado en 2004

Impact of a winter respiratory virus season on patients with COPD and association with influenza vaccination

artículo científico publicado en 2006

Jerome Cornfield's contributions to early large randomized clinical trials and some reminiscences from the years of the slippery doorknobs

artículo científico publicado en 2012

Letter From the DSMC Regarding a Clinical Trial of Lutein in Patients With Retinitis Pigmentosa

artículo científico publicado el 1 de mayo de 2011

Linear Rank Tests for Survival Data: Equivalence of Two Formulations

Missing inaction: preventing missing outcome data in randomized clinical trials

artículo científico publicado en 2009

Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial

artículo científico publicado en 2007

Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board

artículo científico publicado en 2007

New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval

artículo científico publicado en 2016

On changing a long-term clinical trial midstream

artículo científico publicado en 2002

On independent data monitoring committees in oncology clinical trials

artículo científico publicado en 2014

On looking at subgroups

artículo científico publicado en 2009

Outcome measures to assess efficacy of treatments for age-related macular degeneration

artículo científico publicado en 2009

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

artículo científico publicado el 1 de diciembre de 2012

Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors

artículo científico publicado en 2014

Pazopanib versus sunitinib in renal cancer

artículo científico publicado en 2013

Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

artículo científico publicado en 2005

Playing safe and preserving integrity: making the FDA model work.

artículo científico publicado en 2004

Preclinical evaluation of a chimeric malaria vaccine candidate in Montanide ISA 720: immunogenicity and safety in rhesus macaques

artículo científico publicado en 2006

Principal Results of the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) Trial

artículo científico publicado el 23 de abril de 2003

Rationale and trial design of Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON).

artículo científico publicado en 2013

Remembrances of Max Halperin

artículo científico publicado en 1990

Response to Letter Regarding Article, “Effect of Celecoxib on Cardiovascular Events and Blood Pressure in Two Trials for the Prevention of Colorectal Adenomas”

Results of the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) trial by geographical region

artículo científico publicado en 2005

Risk factors for heart failure in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl

artículo científico publicado en 2014

Safety and reactogenicity of an MSP-1 malaria vaccine candidate: a randomized phase Ib dose-escalation trial in Kenyan children

artículo científico publicado en 2006

Sample size calculations for randomized controlled trials.

artículo científico publicado en 2002

Some practical problems in implementing randomization.

artículo científico publicado en 2010

Stopping a trial early - and then what?

artículo científico publicado en 2012

Study design and rationale for the clinical outcomes of the STABILITY Trial (STabilization of Atherosclerotic plaque By Initiation of darapLadIb TherapY) comparing darapladib versus placebo in patients with coronary heart disease

artículo científico publicado en 2010

The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

artículo científico publicado en 2015

The High-Risk Myocardial Infarction Database Initiative

artículo científico publicado el 1 de enero de 2012

The Use of Interim Analysis for Sample Size Adjustment

article

The data monitoring experience in the MOXCON trial

artículo científico publicado en 2004

The impact of kidney function on outcomes following high risk myocardial infarction: findings from 27 610 patients

artículo científico publicado en 2013

The treatment of missing data in a large cardiovascular clinical outcomes study

artículo científico publicado en 2016

Thoughts on A.B. Hill's Watson Lecture

artículo científico publicado en 2021

Times to event: why are they hard to visualize?

artículo científico publicado en 2008

Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research.

artículo científico publicado en 2005

Treatment of HF in an Era of Multiple Therapies: Statement From the HF Collaboratory

scientific article published on 09 December 2020

University of Pennsylvania 5th annual conference on statistical issues in clinical trials: emerging statistical issues in biomarker validation (Morning Session).

artículo científico publicado en 2013

University of Pennsylvania ninth annual conference on statistical issues in clinical trials: Where are we with adaptive clinical trial designs? (afternoon panel discussion).

artículo científico publicado en 2017

Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline

artículo científico publicado en 2009

Use of 5alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline

scientific article published on 26 February 2009

What information should a sponsor of a randomized trial receive during its conduct?

artículo científico