DIA 2022 Global Annual Meeting

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

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

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

Download Registration Form
Registration Questions? Send Email
1.888.257.6457

Return to DIA 2021 

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

Component Type: Tutorial
CE: ACPE 2.75 Application UAN: 0286-0000-22-502-L04-P ; CME 2.75; IACET 2.75; RN 2.75

Preregistration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events

Statistical methods are a powerful tool used in clinical trials to assess whether the data support evidence of a treatment effect. It is therefore key that the results of any statistical analysis are interpreted correctly. However, understanding and interpreting statistical results can be challenging for non-statisticians. In this workshop, participants will be introduced to common statistical methods applied to specific outcomes and their results. Some examples of potential statistical concepts to be covered can include commonly seen hypothesis test, survival analyses, regression modelling, MMRM, and adjusting for multiplicity. Important concepts such as p-values will be explained fully. Idealized examples as well as examples from publicly posted FDA reviews and results on clinicaltrials.gov will be used.

Group discussions using example outputs (including examples from FDA reviews) will give participants the opportunity to apply their learning by critically evaluating statistical analysis approaches and interpreting statistical results, thus giving participants the tools necessary to effectively communicate with their colleagues involved in drug development.


Download Registration Form
Registration Questions? Send Email
1.888.257.6457 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

Return to DIA 2022

Who should attend?

This course would be of interest to those working in clinical trials with a non-statistical background who would like to gain a high-level understanding of statistical analyses and interpretation so they can communicate with their statistical colleagues more effectively.

Learning Objectives

At the conclusion of this short course, participants should be able to:

• Discuss why certain statistical analyses are applied to specific outcomes
• Assess statistical summaries and extract the important information
• Evaluate the statistical results using easily understandable language