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Adaptive Designs for Clinical Trials

Aim of Course:

This course will introduce the adaptive design theory and the hands-on techniques for planning, designing, monitoring, and analyzing adaptive trials. We will summarize the major statistical methods for adaptive trials with an emphasis on the relationships among them. You will learn different adaptive trial designs such as sample-size re-estimation, drop-loser, biomarker-adaptive design, and response-adaptive randomization designs through trial examples and the programming tools provided (SAS and R). Challenges of adaptive trial implementations will be discussed and recommendations are provided. Ultimately, the attendees are expected to walk away with the right knowledge, skill, and tools for designing and managing adaptive trials.

Who Should Take This Course:

Statisticians with responsibility for designing, analyzing and reporting clinical trials.

For those enrolled in a Program of Advanced Statistical Studies, this is a required or elective course in the following Programs:

  • Biostatistics (controlled trials) - required

Course Program:

The course is structured as follows:

SESSION 1: A Unified Statistical Approach for Adaptive Design
  • Overview of Adaptive Designs
  • Statistical methods for Classical Trial Designs
  • Unified Formulation for Adaptive Trial Designs
SESSION 2: Commonly Used Statistical Methods for Adaptive Trial Design
  • Method with Direct Combination of Stagewise P-values for Two-Stage Design
  • Method with Inverse-Normal Stagewise P-Values for Two-Stage Design
  • K-Stage Adaptive Trial Designs
SESSION 3: Applications of Adaptive Designs
  • Sample-Size Reestimation Design
  • Drop-Loser Design
  • Response-Adaptive Randomization Design
  • Adaptive Dose-Escalation Design
  • Biomarker-Adaptive Design
SESSION 4: Recursive Adaptive Design; Trial Monitoring and Analysis
  • Conditional Error Function method
  • Recursive Adaptive Design
  • Conditional Power and Trial Monitoring
  • Analysis of Adaptive Trial Data

Organization of the Course:

The course takes place over the internet, at statistics.com. During each course week, you participate at times of your own choosing - there are no set times when you must be online. Course participants will be given access to a private discussion board. In class discussions led by the instructor, you can post questions, seek clarification, and interact with your fellow students and the instructor. The course is scheduled to take place over 4 weeks, and typically requires 15 hours per week. At the beginning of each week, you receive the relevant material, in addition to answers to exercises from the previous session. During the week, you are expected to go over the course materials and work through exercises. Discussion among participants is encouraged. The instructor will provide answers and comments.

Certificates and Grades:

You may be interested only in learning the material presented, and not be concerned with grades or certificates. Or you may be enrolled in a statistics.com Program in Advanced Statistical Studies that requires demonstration of proficiency in the subject, in which case your work will be assessed for purposes of issuing a grade. Or you may require only a "Certificate of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's). As you begin the class, you will be asked to specify your category.

Credit:

This course offers continuing education units (CEU's). For those successfully completing the course (generally this means marks of 50% or better on the homework), 5.0 CEU's and a certificate will be issued by statistics.com, upon request.

Dates:

Oct. 29 - Nov. 26, 2010
Click here to be notified of future course offerings.

Participants gain access to the online materials on the first day of the course, and typically spend about 15 hours per week (at their convenience). You retain full access to course materials, including discussion board, for two weeks after the course closing date.

Level:

Intermediate/Advanced

Prerequisite:

Participants should be familiar with the material covered in Biostatistics 1, and Biostatistics 2 as well as the material covered in Avoiding Selection Bias in Randomized Clinical Trials.

Course Text:

The text for this course will be announced September 1, 2010.

Software:

Illustrations are provided in ExpDesign, which comes bundled with the supplementary course text. ExpDesign is an integrated software environment for classical and adaptive designs. It includes over 100 methods for classical design and commonly used adaptive methods for design and monitoring. The graphical interface make the software user-friendly.

Registration:

Register Online - $499
Register Online (academic) - $399 (you must be affiliated with a college, university or high school)

Add $50 service fee if you require a prior invoice, or if you need to submit a purchase order or voucher, pay by wire transfer or EFT, or refund and reprocess a prior payment. Please use this printed registration form, for these and other special orders.

Consider registering for this course together with two other Clinical Trials courses as part of our special 3 course package registration for tuition savings.

Note: Courses may fill up at any time and registrations are processed in the order in which they are received. Your registration will be confirmed for the first available course date, unless you specify otherwise.

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