Meetings

MEETINGS, WEBINARS AND SYMPOSIA

CAPRA Dinner Meetings, Webinars and Symposia Schedule

 

Date/Location Speakers/Topics

Monday, October 22

The Westin Bristol Place Toronto Airport
950 Dixon Road
Toronto, ON M9W 5N4

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CAPRA Annual General Meeting

Date: Monday, Oct 22nd, 2018
 
Place: The Westin Bristol Place Toronto Airport
950 Dixon Road, Toronto, ON     M9W 5N4
 
Time: Registration: 4:00 - 4:30 pm
AGM: 4:30 - 5:30 pm (before the dinner meeting)

Please note: AGM is for CAPRA members only. 
There is NO charge to attend the AGM. Registration is a must. 
Registering for the AGM does not register you for the Toronto Dinner Meeting.

A teleconference number can be provided to those who wish to participate over the phone.  The number can be requested by contacting Hareet Aujla at administrator@capra.ca

Monday, October 22

The Westin Bristol Place Toronto Airport
950 Dixon Road
Toronto, ON M9W 5N4

Register now

Toronto Dinner Meeting

Date: Monday, Oct 22nd, 2018
 
Place: The Westin Bristol Place Toronto Airport
950 Dixon Road, Toronto, ON   M9W 5N4
 
Time: Registration and reception: 5:30-6:15 pm 
Presentation: 6:15-7:30 pm 
Dinner: 7:30 - 9:00 pm
 
Please Note: Registering for the Toronto Dinner meeting does not register you for AGM.
 
Dinner Meeting Title: E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials (Addendum to ICH E9 – Statistical Principles for Clinical Trials)
 
Description:  An addendum to ICH E9 (Statistical Principles for Clinical Trials) is currently under development. The purpose of the addendum is to develop regulatory guidance, which promotes harmonised standards on the target of estimation (the estimand) in clinical trials, and describes an agreed framework for planning, conducting and interpreting sensitivity analyses. As with ICH E9, the Addendum will focus on statistical principles related to estimands and sensitivity analyses, not on the use or acceptability of specific statistical procedures or methods.

In this presentation, a new framework for aligning the estimand, the method of estimation (estimator), and sensitivity analyses for a given trial objective will be introduced.  The four attributes that together describe the estimand are discussed, as are the proposed strategies for addressing intercurrent events.  In the new framework, intercurrent events are defined as events that occur after treatment initiation and either preclude observation of the variable or affect its interpretation. With regards to the construction of estimands, general as well as therapeutic and experimental context considerations will be discussed. Finally, the presentation will address the impact of the new framework on trial design, conduct and analysis.

Speaker: Catherine Njue, PhD
Biostatistics Advisor – Clinical Trials, Biologics and Genetic Therapies Directorate, Health Canada
 
Dr. Catherine Njue is a Biostatistics Advisor for Clinical Trials in the Biologics and Genetic Therapies Directorate, Health Canada. In this position, she is primarily involved in evaluating the statistical methodology of clinical trials for biologics (e.g., vaccines, blood products) and related biotechnology products and radiopharmaceuticals. She also provides statistical expertise in the drafting, review and implementation of standards and guidelines developed by Health Canada, ICH, and WHO working groups.