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11: Statistics [clear filter]
Monday, June 24

2:15pm PDT

#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data visualization can transform and advance clinical trial safety analysis. Discover the latest data visualization use cases for safety and how dynamic data exploration yields meaningful data review, better patient outcomes and trial efficiency.

Learning Objectives

Discuss various data visualization examples that can be applied to the area of clinical trial safety analysis; Outline key benefits and efficiencies statisticians, medical monitors, and others in charge of safety can achieve through data visualizations that are being used in this area of clinical trials today.


Demi Niforos, MS


Summary of Safety Visualization Efforts
William Wang, PhD

Nathan Bennett, PhD, MA


Demi Niforos

Vice President, Biostatistics and Statistical Programming, eClinical Solutions
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →

Monday June 24, 2019 2:15pm - 3:15pm PDT
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics, Forum |   01: ClinSafety-PV, Forum |   02: ClinTrials -ClinOps, Forum |   03: Data-Data Standards, Forum

6:00pm PDT

Community Meet Up: Statistics Community Meet and Greet
Component Type: Forum

Please join the Statistics Community for a meet and greet. This is an opportunity for members and non-members to learn more about our Community and activities, to share ideas and discuss future direction, and most importantly to volunteer and be part of a dynamic group!


Joan Buenconsejo, PhD, MPH

avatar for Joan Buenconsejo

Joan Buenconsejo

Senior Director, Biostatistics, AstraZeneca
Joan Buenconsejo is Senior Director, Biostatistics supporting late stage cardiovascular, renal and metabolic therapeutic areas within biopharmaceutical R&D at AstraZeneca. Prior to AZ, she was a statistics team lead at CDER, FDA. Dr. Buenconsejo is chair of the DIA Statistics Community... Read More →

Monday June 24, 2019 6:00pm - 7:00pm PDT
Community Area 2 Sails San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
Wednesday, June 26

8:00am PDT

#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-657-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.

Learning Objectives

Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.


Munish Mehra


Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD

Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc

Estimands for Efficacy Analyses
Thomas J. Permutt, PhD


Martin Clancy

Senior Statistician, PHASTAR
I'm a Senior Statistician at PHASTAR, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services by providing expert consultants and delivering in-house projects. Working in a Contract Research Organisation (CRO) for the past 4 years... Read More →
avatar for Yi Liu

Yi Liu

Director Biostatistics, Nektar Therapeutics
Yi Liu got her Ph.D. degree in Statistics from the department of Statistics at The Ohio State University. She is currently a director at Nektar Therapeutics responsible for clinical trials in collaborations with external partners and CMC and biomarker related statistical analyses... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across... Read More →
avatar for Thomas Permutt

Thomas Permutt

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA
Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect... Read More →

Wednesday June 26, 2019 8:00am - 9:15am PDT
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics, Forum |   02: ClinTrials -ClinOps, Forum |   03: Data-Data Standards, Forum
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

10:30am PDT

#344: Meaningful Patient-Focused Drug Development for Rare Disease and Personalized Medicine
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-672-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide a platform to discuss measurement challenges and practical considerations for selection of fit-for-purpose clinical outcome assessments (COAs) to support endpoints in rare disease drug development programs.

Learning Objectives

Discuss practical considerations for utilizing clinical outcome assessments (COAs) to support clinical trial endpoint(s) in drug development; Identify the measurement challenges and recommendations for the selection of COAs for rare disease drug development.


Michelle Campbell, PhD


Generalized Pairwise Comparisons for Benefit/Risk Assessment in Personalized Medicine
Marc E. Buyse, DrSc

Endpoint Selection and Use of Clinical Outcome Assessments (COAs) in Rare Disease Drug Development: A Regulatory Perspective
Lili Garrard, PhD

Selection of Fit-for-Purpose COAs to Support Endpoints in Rare Disease
Jean Paty, PhD

avatar for Marc Buyse

Marc Buyse

Chief Scientific Officer, International Drug Development Institute (IDDI)
Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute... Read More →
avatar for Michelle Campbell

Michelle Campbell

Senior Clinical Analyst for Stakeholder Engagement, DNP, OND, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →

Lili Garrard

Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA
Lili Garrard is a statistical reviewer on the Clinical Outcome Assessment (COA) Statistical Support Team at the Division of Biometrics III, Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration... Read More →
avatar for Jean Paty

Jean Paty

Vice President, Patient-Centered Science, IQVIA
Jean Paty is a leader in effective strategies and practices of capturing patient experience data for use in clinical development and commercial success of new and existing medical products. Jean has been published extensively in the areas of Clinical Outcome Assessments (COA) and... Read More →

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics, Forum |   05: Patient Engagement, Forum |   02: ClinTrials -ClinOps, Forum