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List of works by 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

scientific article published on 30 May 2007

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

scientific article published in May 2005

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

scientific article published on July 2015

Assessing correlates of protection in vaccine trials

scientific article

Bardoxolone methyl and kidney function in CKD with type 2 diabetes

scientific article

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

scientific article

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

scientific article published in January 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

scientific article published in November 2013

Bias and trials stopped early for benefit.

scientific article published in July 2010

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

scientific article

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

scientific article

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

scientific article published on 5 July 2007

Celecoxib for the prevention of colorectal adenomatous polyps

scientific article (publication date: 31 August 2006)

Celecoxib for the prevention of sporadic colorectal adenomas

scientific article (publication date: 31 August 2006)

Clinical trials must cope better with multiplicity ⬇️

scientific article published on November 1, 2012

Comment on paper by Crowe et al.

scientific article

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

scientific article published in November 2009

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

scientific article published on 01 January 2019

Comments on the FDA Draft Guidance on Adaptive Designs ⬇️

scientific article published on November 1, 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.

scientific article

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

scientific article published in January 2002

Discussion of Paper by Korn and Freidlin ⬇️

journal article; published in The American Journal of Bioethics in 2011

Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure

scientific article published on 12 April 2017

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

scientific article

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

scientific article

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

scientific article published in May 2003

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

scientific article

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

scientific article published on September 2015

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

scientific article published in November 2004

Immunity to influenza in older adults with chronic obstructive pulmonary disease

scientific article published on 26 May 2004

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

scientific article published in October 2006

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

scientific article published on 2 September 2012

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

scientific article published on May 1, 2011

Linear Rank Tests for Survival Data: Equivalence of Two Formulations

Missing inaction: preventing missing outcome data in randomized clinical trials

scientific article

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

scientific article

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

scientific article

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

scientific article published on 19 April 2016

On changing a long-term clinical trial midstream

scientific article (publication date: 15 October 2002)

On independent data monitoring committees in oncology clinical trials

scientific article

On looking at subgroups

scientific article published in February 2009

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

scientific article published on October 2009

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

scientific article published on December 2012

Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors

scientific article

Pazopanib versus sunitinib in renal cancer

scientific article published in November 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

scientific article published on 7 December 2005

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

scientific article published in May 2004

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

scientific article published in September 2006

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

scientific article published on April 23, 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).

scientific article published on 28 February 2013

Remembrances of Max Halperin

scientific article published on 01 August 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

scientific article published in May 2005

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

scientific article published on 13 October 2014

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

scientific article

Sample size calculations for randomized controlled trials.

scientific article

Some practical problems in implementing randomization.

scientific article published in June 2010

Stopping a trial early - and then what?

scientific article published on 9 August 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

scientific article published on October 2010

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

scientific article

The High-Risk Myocardial Infarction Database Initiative ⬇️

scientific article published on January 1, 2012

The Use of Interim Analysis for Sample Size Adjustment

article

The data monitoring experience in the MOXCON trial

scientific article

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

scientific article published on 6 December 2013

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

scientific article

Thoughts on A.B. Hill's Watson Lecture

scientific article published on 01 January 2021

Times to event: why are they hard to visualize?

scientific article

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

scientific article

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).

scientific article

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

scientific article published in August 2017

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

scientific article

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?

scientific article published on 24 October 2011

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