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ICON Invites You to Learn When to Re-Estimate the Sample Size
Improving the Efficiency of Clinical Studies Complimentary Webinar
To register click here
When planning phase IIb and/or phase III trials, uncertainty may still exist about the assumptions needed for a precise sample size calculation.
One approach to deal with this uncertainty is to incorporate a blinded or unblinded sample size re-estimation into the study design. The option to reassess sample size in an ongoing trial should not be seen as a substitute for careful planning. However, the need to reassess sample size in some circumstances is acknowledged by regulators.
There has been a large amount of published research on blinded and unblinded sample size reassessment. In this webinar these approaches will be explained in ways that are easily understandable, using real-life examples.
Topics to be covered:
- What can be reassessed while complying with regulatory requirements?
- When should sample size reassessment be conducted?
- How should sample size reassessment be performed?
- Vivian Alderfer, Ph.D.
Senior Biostatistician, Senior Project Director
ICON Clinical Research
- Richard Kay, Ph.D.
Independent Statistical Consultant and Trainer to the Pharmaceutical Industry
RK Statistics Ltd.
- Tim Clark
Vice President of Scientific Affairs
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