Adaptive Designs for Clinical Trials

Brief Description:

This course will teach you how to design, monitor and analyze clinical trials using statistically sound principles that incorporate interim looks at the data, possible early stopping, and sample size re-estimation at interim. It covers group sequential designs, adaptive dose finding (escalation) designs, and two-stage (e.g., phase I/II) adaptive designs. In addition, the impact of protocol amendments on clinical outcomes will also be studied.

Instructor(s):
Level: Intermediate/Advanced

Who Should Take This Course:

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

Dates:
March 23, 2012 to April 20, 2012
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Registration:
Please read the syllabus tab, noting the prerequisites, text and software requirements.

Register Online -$499
Register Online -$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.

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. Multiple course registrations may be entitled to tuition discounts; read more.

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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.

Prerequisite(s):

• Biostatistics 1, and Biostatistics 2
• Avoiding Selection Bias in Randomized Clinical Trials

Course Program:

SESSION 1:

• General Concept
• Fundamental Theory
• Group Sequential Design
• Adaptive Interim Analysis in Clinical Trials

SESSION 2: 

• Adaptive Dose Finding Design
• Enrichment Design for Target Clinical Trials

SESSION 3: 

• Two-Stage Adaptive Design
• Sample size estimation/allocation

SESSION 4:

• Protocol Amendments
• Clinical Trial Simulation
• Efficiency of Adaptive Design
• Case Studies

Organization of the Course:

This course takes place over the internet, at statistics.com for 4 weeks. 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 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, work through exercises, and submit answers. Discussion among participants is encouraged. The instructor will provide answers and comments, and you will receive individual feedback on your homework answers.

Credit:
Students come to The Institute for a variety of reasons:

1. You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
2. You may be enrolled in PASS (Program in Advanced Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
3. You may require a "Record 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.

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 record of course completion will be issued by Statistics.com, upon request.

Course Text:

The following texts will be used during the course:

Pong, A.P. and Chow, S.C. (2010). Handbook of Adaptive Designs in Pharmaceutical and Clinical Development. Chapman and Hall/CRC, Taylor & Franics, New York, New York.  If you would like to receive a 25% discount from the publisher, please use this form.

FDA Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics, The U.S. Food and Drug Administration, Rockville, Maryland, February, 2010, which can be downloaded here.

Software:

Students will have access to EaSt software, which implements some of statistical methods for the adaptive clinical trial designs described in the text book.  Illustrations and demos will be provided for students to work through on their own.

Register Now

Yes, I want to register for:

Adaptive Designs for Clinical Trials

Instructor(s):
Dates:
March 23, 2012 to April 20, 2012
Course Fee: $499
Academic Discounted Rate: $399

Before registering, please read the syllabus tab, noting the prerequisites, text and software requirements. When you click the register button, you will be taken to our secure transaction page.

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