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Monday, June 13 • 2:00pm - 5:00pm
12P: Defining the Clinical Questions of Interest: Why Everyone Developing a Protocol Should Understand Estimands!

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Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-501-L04-P ; CME 2.75; IACET 2.75; RN 2.75

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People familiar with the design, conduct and analysis of clinical trials understand efficacy endpoints and their analyses, however the term estimand is not familiar to most non-statisticians. While many groups and large companies are moving forward and implementing ICH E9 R1 as well as incorporating estimands into their protocols, some companies have yet to understand or incorporate the components of an estimand in their trial design.

The final definition of an estimand in ECH E9 R1 is “A precise description of the treatment effect reflecting the clinical question posed by the trial objective. It summarizes at a population-level what the outcomes would be in the same patients under different treatment conditions being compared.“ and “An estimand is a parameter which is to be estimated in a statistical analysis. The term is used to more clearly distinguish the target of inference from the function to obtain this parameter (i.e., the estimator) and the specific value obtained from a given data set (i.e., the estimate).”

Regulatory agencies have not consistently asked for estimands in late-stage trials making it harder for industry to follow. What is needed is a way to simplify and effectively communicate the key concepts around the use of estimands and sensitivity analyses to non-statisticians.

This presentation will share the current status of industry’s understanding and adoption of estimands. Example estimands pertaining to diseases will be reviewed. The presentation will also suggest ways to improve understanding of estimands as statisticians communicate the concepts of ICH E9-R1 to non-statisticians.

Registration info: Rate: $350
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Upon completion of registration, participants will gain access to the following:
  • Live Event Access
  • Presentation Slides

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Who should attend?

Statisticians, non-statisticians, and physicians involved in clinical protocol review or development.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Discuss why the estimand framework and sensitivity analyses as described in ICH E9 are important for non-statisticians to understand
  • Review example estimands and how one can apply the estimand framework to most Phase 2 and 3 studies
  • Apply the Estimand framework and concepts to develop better protocols


Rekha Jhamnani

Medical Officer, DPACC, OND, CDER, FDA, United States
Rekha Jhamnani is a medical officer in the Division of Pulmonology, Allergy, and Critical Care at the FDA. She completed medical school at the George Washington University School of Medicine and internal medicine residency at Georgetown University Hospital. She then completed a fellowship... Read More →

Khalid Puthawala

Medical Officer, DPACC, OND, CDER, FDA, United States
avatar for Elisa Gomez Valderas

Elisa Gomez Valderas

Senior Advisor, Eli Lilly and Company, United States

Monday June 13, 2022 2:00pm - 5:00pm CDT
Virtual McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  20: Short Courses, Tutorial |   11: Statistics, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial