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Wednesday, June 29 • 10:30am - 11:45am
#324: Implementing Adaptive Designs Involves Greater Teamwork

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Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-584-L05-P; CME 1.25; IACET 1.25; RN 1.25

Adaptive designs require more planning and teamwork than traditional clinical trials. In this session, the speakers will discuss their enhanced roles and those of the other team members.

Learning Objectives

Demonstrate how to lead and/or collaborate with all relevant parties on designing and executing adaptive clinical trials; Assess alternative adaptive trial designs for enhancing trial efficiency and patient safety; Describe how to design operational processes to minimize bias when unblinding data during interim analysis.

Chair

Eva R. Miller, PhD, MS

Speaker

The Biostatistician's Role in Adaptive Design Team: Power Calculations Using GSDesign
Kenneth Liu, PhD

The Drug Supplies Manager’s Role in Planning and Implementing Flexible Drug Supply Management in Adaptively Designed Trials
Micheline D Marshall, MBA

Pivotal Roles of the Statistician, Physician, and Project Manager in Simple and Complex Adaptive Trial Designs
Richard McNally



Chair
avatar for Eva Miller

Eva Miller

Independent Biostatistical Consultant, Self-Employed
Eva Miller is Senior Director, Biostatistics, at inVentiv Health. Eva works with sponsors to design and implement adaptive clinical trials in over 30 therapeutic areas.. Eva received her Ph.D. at the U of P and is a member of DIA, DIA Statistics SIAC, ASA, and Adaptive Designs Working... Read More →

Speakers
KL

Kenneth Liu

Senior Principal Scientist, Merck & Co. Inc.
Kenneth Liu is a Senior Principal Scientist in the biostatistics department at Merck. Over his 15 years at Merck, he has designed, implemented, and published the results of adaptive trials in oncology and neuroscience. He graduated from the University of Pittsburgh’s Department... Read More →
avatar for Micheline Marshall

Micheline Marshall

Head Randomization and Trial Supply Management, Janssen Pharmaceutical Companies of Johnson & Johnson
Micheline has 20 years’ experience developing and implementing Randomization & Trial Supply Management (RTSM) strategies. She is a proponent of the team approach with stakeholders from Clinical, Clinical Supplies, Regulatory, Quality and the Service Providers working together to... Read More →
RM

Richard McNally

Statistical Fellow, Covance Inc.
Richard McNally is a Statistical Fellow at Covance, where he provides statistical consulting to clients on clinical study design, serves as the lead statistician on clinical studies, and is an independent statistician for Data Monitoring Committees. He has given presentations on adaptive... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA