ICON Invites You to Learn When to Re-Estimate the Sample Size

Improving the Efficiency of Clinical Studies Complimentary Webinar

(PresseBox) ( Dublin Ireland, )
ICON plc (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, announced details today of its upcoming complimentary webinar, Improving the Efficiency of Clinical Studies: When to Re-Estimate the Sample Size?

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?

Expert Panelists:

- 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
ICON plc
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