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December 4, 2014 From Sample Size Calculations to Clinical Trial Optimization




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Title: From Sample Size Calculations to Clinical Trial Optimization
Presenters: Alex Dmitrienko, Quintiles, and  Gautier Paux, Servier
Date and Time: Thursday, December 4, 2014, 12:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Tuesday, December 2, at 12:00 p.m. Eastern time

Description:
It is well known that sample size determination is one of the key aspects of designing a new clinical trial.  A standard sample size calculation approach generally pursues a simple goal of computing a quick estimate of the required number of patients or events.  Closed-form solutions are normally preferred, which often forces the trial’s sponsor to make simplifying assumptions. The clinical scenario evaluation (CSE) framework introduced in Benda et al (2010) provides an extended version of this basic “one-dimensional” approach.  Clinical scenario evaluation focuses on a broad “multi-dimensional” approach to a quantitative assessment of the operating characteristics of several candidate analysis methods under multiple candidate trial designs to arrive at a solution which is consistent with the trial’s clinical objectives and maximizes a relevant success criterion or utility function.
 
In this webinar we will introduce the key principles of clinical scenario evaluation in the context of Phase II and Phase III clinical trials and touch upon multiple related approaches.  We will discuss the general concept of clinical trial optimization aimed at identifying the configurations of applicable design scenarios and analysis strategies that lead to optimal performance.  We will also emphasize the importance of sensitivity assessments to ensure that an optimal clinical trial design is robust to reasonable deviations from the assumed parameter values.
 
The CSE approach will be illustrated using case studies based on a clinical trial with multiple objectives, clinical trial with a biomarker-driven design and an adaptive Phase II clinical trial.  Finally, we will introduce an R package (Mediana package) which was developed to provide a general software implementation of the CSE approach. The current version of the Mediana package supports a broad set of clinical trial designs and analysis methods, and we will discuss new features that will be added in the future.
 
References
Benda, N., Branson, M., Maurer, W., Friede, T. (2010). Aspects of modernizing drug development using clinical scenario planning and evaluation. Drug Information Journal. 44, 299-315.
Dmitrienko, A., Paux, G., Brechenmacher, T. (2014). Power calculations in clinical trials with complex clinical objectives. In press.

Registration Fees:
Biopharmaceutical Section Members: $44
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

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Access Information
Registered persons will be sent an email the afternoon Tuesday, December 2, with the access information to join the webinar and the link to download and print a copy of the presentation slides.