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Spring 2008 training series
Spring 2008 training series includes webinars
on surrogate endpoints (Three-part series on statistical evaluation
of surrogate endpoints in clinical trials) and a webinar on the
assessment of QTc prolongation in clinical trials.
Webinars 1-3: Three-part series on statistical
evaluation of surrogate endpoints in clinical trials
For more information about this series, download
its outline. Download
handouts (handouts for all three webinars are included in
a single PDF file).
Webinar 1: Setting the Scene
Presented by Prof. Geert Molenberghs (Center
for Statistics, Universiteit Hasselt, Diepenbeek, Belgium) on
Thursday, February 21, 2008 (noon-2:00 Eastern time).
The following topics will be discussed: The
concept of surrogacy, Basic taxonomy, Key examples, Prentice's
definition, Proportion of treatment effect explained, Adjusted
association and relative effect, The need for trial-level replication.
Webinar 2: Meta-analytic Framework
Presented by Prof. Geert Molenberghs (Center
for Statistics, Universiteit Hasselt, Diepenbeek, Belgium) on
Thursday, March 27, 2008 (noon-2:00 Eastern time).
The following topics will be discussed: The
framework for continuous outcomes, Issues in parameter estimation,
Prediction, Binary endpoints, Survival endpoints, An ordinal surrogate
for a survival true endpoint, A longitudinal surrogate for a survival
true endpoint.
Webinar 3: Towards Unification
Presented by Prof. Geert Molenberghs (Center
for Statistics, Universiteit Hasselt, Diepenbeek, Belgium) on
Thursday, April 24, 2008 (noon-2:00 Eastern time).
The following topics will be discussed: Surrogacy
in psychiatry, Longitudinal endpoints, A suite of measures, Information
theoretic unification, Surrogate threshold effect, Substantive
conclusions and outlook, Methodological conclusions and outlook.
Webinar 4: Assessment of QTc prolongation
in clinical drug development
Presented by Dr. Alex Dmitrienko (Lilly)
on Thursday, May 22, 2008 (noon-2:00 Eastern time).
Assessment of cardiac liability of new compounds,
particularly with respect to life threatening ventricular tachydysrhythmias,
e.g., Torsades de Pointes (TdP), is becoming an increasingly important
component of clinical drug development. Lengthening of QTc interval
is commonly used as a surrogate biomarker for an increased risk
of TdP. The International Conference on Harmonization (ICH) published
a guidance document (ICH E14) to describe strategies for the evaluation
of cardiac safety of drugs in clinical development. This document
introduced a new approach to the assessment of proarrhythmic potential
of new drugs (thorough QT/QTc study). Thorough QT/QTc study are
now required for virtually all non-cardiac drugs with systemic
bioavailability and design and analysis considerations in thorough
QT/QTc studies have received much attention in clinical trial
literature.
This webinar will focus on statistical issues arising in the design
and analysis of thorough QT/QTc studies, including
1. Key design issues (single-dose and steady-state designs, time
points for ECG acquisition, number of replicate ECG recordings,
etc).
2. Common approaches to the analysis of QTc interval data in thorough
QT/QTc studies (e.g., QT correction methods, multiplicity issues,
QTc-exposure analysis, etc).
Handouts
Webinar's web page
A web
page has been set up for this webinar to provide supplementary
materials (white paper on thorough QT studies, references, links,
etc). Registration
Registration fee is only $44 for members
of the Biopharmaceutical Section. ASA members have an option to
join the section for $8 and receive the section member rate. To
register for individual training courses, visit the
Biopharmaceutical Section's web page. |
