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Trk 15: Statistics [clear filter]
Monday, June 27
 

8:30am

#118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will review best practices for quantifying a meaningful change in a patient-reported outcome (PRO) endpoint and establishing a responder definition in the presence of missing score data. Missing data strategies that do not assume absence of a PRO score means “non-responder.”

Learning Objectives

Recognize problems in responder analyses if subjects discontinue study treatment or withdraw from a trial; Compare approaches published by EMA, NAS, and in the ICH E9(R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials; Recognize how to combine multiple missing data approaches to tell the data story.

Chair

Scott Komo, DrPH

Speaker

Panelist
Yeh-Fong Chen, PhD

Panelist
Lisa A Kammerman, PhD, MS



Chair
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →

Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →


Monday June 27, 2016 8:30am - 9:45am
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

2:00pm

#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, we will discuss open-label, delayed-start studies and open-label extension studies that are conducted to evaluate safety and efficacy. A statistician will describe delayed-start study designs and an epidemiologist will discuss when such studies are needed, and the interpretation of study findings. An ethicist will identify the ethical aspects of these study designs and their conduct.

Learning Objectives

Explain the objectives of open-label, long-term extension studies; Describe the role and design of delayed-start studies and single-arm extension studies in the evaluation of efficacy and safety; Discuss ethical considerations when designing and conducting open-label, long-term extension studies.

Chair

Lisa A Kammerman, PhD, MS

Speaker

Delayed-Start Study Design and Analyses for Demonstrating Disease Modification
Scott Andersen, MS

Bioethics of Open-Label Extension Studies
Robert M Nelson

When, if Ever, Open-Label Extension Studies Are Needed and Appropriate (and What Are the Alternatives)?
Jesse Aaron Berlin, DrSc



Chair
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →

Speakers
SA

Scott Andersen

Principal Research Scientist, Eli Lilly and Company
Scott has been a statistician designing and analyzing neuroscience clinical trials for nearly 20 years. While most of his research has focused on depression and schizophrenia disease states, Scott has spent the last five years working on Alzheimer's Disease. In 2015, Scott co-authored... Read More →
avatar for Jesse Berlin

Jesse Berlin

Vice President and Global Head of Epidemiology, Johnson & Johnson
Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored... Read More →
avatar for Robert Nelson

Robert Nelson

Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric Therapeutics, OC, FDA
Robert “Skip” Nelson, M.D., M.Div., Ph.D. is currently the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

4:00pm

#374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Futility analysis is increasingly used in clinical studies. The implementation of futility rules present some special considerations in study design and conduct, and this forum will focus on some of these critical aspects. Through the use of case studies, we will review a futility analysis based on preliminary questionnaire data where interim and final results were discordant and a phase 3 adaptive study design that includes futility analysis methods. Further discussions and considerations include the pros and cons of the futility analysis, clinical considerations, recruitment rate, and impact on the clinical program.

Learning Objectives

Describe the limitations and risks of futility analysis; Explain the role of data management in futility analysis; Discuss the risks associated with interpretation of results from dirty data.

Chair

Brenda Crowe, PhD

Speaker

The Futility of Futility Analysis
Imogene McCanless Dunn

Design of Futility Analysis in a Phase 3 Clinical Trial
Feng Liu, MSc



Chair
avatar for Brenda Crowe

Brenda Crowe

Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.

Speakers
avatar for Imogene Dunn

Imogene Dunn

Senior Vice President, Biometrics and Regulatory Affairs, vTv Therapeutics
Imogene McCanless Dunn, Ph.D., has more than 25 years experience in data sciences (data management, biostatistics, and informatics, and regulatory affairs). A key focus of career has been regulatory data sciences, leveraging progressive regulatory methodologies and strategies while... Read More →
avatar for Feng Liu

Feng Liu

Manager, Statistics, RD Projects Clinical Platforms and Sciences, GlaxoSmithKline
Mr. Feng Liu is Manager, in Clinical Statistics Department at GSK. He has more than fifteen years of experience in non-clinical and phase I-III pharmaceutical development. He advocates the application of efficient designs to improve productivity and reduce the failure rate in the... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA