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Web-based Training Series
Member of the Biopharmaceutical Section: $44
ASA Member: $59
Each registration is allowed one web connection and one audio connection. The Biopharmaceutical Section encourages multiple persons to view each registered connection (for example, by projecting the webinar in a conference room).
Adaptive Population Enrichment Designs in Confirmatory Clinical Trials
Vlad Dragalin (Aptiv Solutions)
Tuesday, January 22, 2013, 12:00 p.m. - 2:00 p.m. Eastern time
Registration Deadline: Noon Eastern time, Monday, January 21
Recent breakthroughs in identifying clinically actionable biomarkers allow a paradigm shift in clinical trial design and a focus on patient subpopulations with potentially greater treatment effect. Instead of limiting the enrollment only to the enriched population, prospectively specified adaptive designs enable the data-driven selection of one or more pre-specified subpopulations in an interim analysis and the confirmatory proof of efficacy in the selected subset at the end of the trial. Sample size reassessment and other adaptive design changes can be performed as well. Strong control of the familywise Type I error rate is guaranteed by combining closure principle and p-value combination tests. In this presentation, the general methodology and designing issues when planning such a design will be described. Criteria for assessing the operating characteristics of these designs will be given, and the application will be illustrated by examples.
REGISTRATION IS CLOSED
Registered attendees will be emailed the access information for the webinar the afternoon of Monday, January 21.
Presentation Slides (color)
A webinar is a seminar which is conducted over the World Wide Web. It is a type of web conferencing. In contrast to a Webcast, which is transmission of information in one direction only, webinars are designed to be interactive between the presenter and audience. A webinar is 'live' in the sense that information is conveyed according to an agenda, with a starting and ending time. In the case of the Biopharmaceutical Section Webinar Series, the presenter speaks over a standard telephone line, pointing out information being presented on screen. The audience receives the audio of the presentation via telephone call-in number of audio streaming over the internet. The audience can respond via a chat feature. The word 'webinar' is a blend of web and seminar.
Operating System: Windows 2000 to present, Macintosh OSX, Linux Redhat
Browser: Internet Explorer (IE) 5.5+, Firefox 2.0+, Opera
9.0+, Mozilla 1.71+, Safari 3.1
Other: Events with streaming audio or video require Macromedia Flash 8.0+
Hardware: 56Kbps Internet access. Speakers or headphones and cable modem,
DSL, ISDN, or equivalent broadband needed to receive audio/video streaming
*Opera browser will not allow access to the Question and Answer feature
of the console.
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