If you are interested in attending the following course or wish to know more details, please reply using the contact details provided and not to me.
A PSI ½ day Workshop on Design, Simulation and Monitoring of Group Sequential Methods and Adaptive Clinical Trials
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presented by Cyrus Mehta (Cytel Inc)
13th May 2007, Carden Park Hotel, nr Chester
Course Outline:
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This half day workshop will focus on methods for designing two types of phase III trials; group sequential trials with time to event endpoints and adaptive trials with mid course corrections. The group sequential methodology is especially suitable for time to event designs where large savings of study duration are possible through the adoption of early stopping boundaries for efficacy and futility. Such designs, however, involve a complex trade off involving sample size, patient follow up time and total study duration. We shall illustrate this trade off by re-designing a recently completed clinical trial comparing uncoated and drug eluting stents for patients with acute myocardial infarction. There has been a considerable amount of recent research on adaptive trials, broadly defined as trials in which mid-course alterations of key design parameters are permitted based on unblinded interim analyses of the accruing data. Such designs are interesting to investigators because they offer the potential to learn from the data already accumulated, thereby refining the study design and improving its chances of success, rather than starting all over again with a new trial. Important mid-course alterations include changes in sample size or duration of follow-up, and dropping of treatment arms. The statistical validity of these methods, as well as the related operational issue of preventing an on-going trial from being unblinded prematurely, will be discussed. Software support for this workshop will be provided by the East-5 software package.
Course Timings:
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This workshop will start at 2.30pm on Sunday 13th May 2007 at the Carden Park Hotel, nr Chester, UK.
Registration:
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Please register using the PSI Conference registration form. Delegates who registered for the conference before 2nd March 2007 who wish to add this workshop will be entitled to the discounted rate of £95 + VAT, the standard rate is £110 + VAT. Delegates may register just for this workshop if they do not wish to attend the entire conference. The full conference brochure and the registration form can be downloaded from the PSI website at www.psiweb.org
Contact:
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For more information, please contact the PSI Executive office by phone +44 (0)1625 267882, email [log in to unmask] or Fax +44 (0)1625 267879
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