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
Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
Enhance your experience and register for two or more short courses at the same time and receive $50 in savings. Purchase must happen at same time. Discount will be reflected on the last page of the cart.Upon completion of registration, participants will gain access to the following:
- Live Event Access
- Presentation Slides
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DIA 2021 Who should attend?Statisticians, non-statisticians, and physicians involved in clinical protocol review or development.
Learning ObjectivesAt 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
