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Wednesday, June 29 • 4:00pm - 5:00pm
#374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations

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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.


Brenda Crowe, PhD


The Futility of Futility Analysis
Imogene McCanless Dunn

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

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.

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 EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum