Adaptive Designs for Clinical Trials

Dr. Mark Chang

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 Professional Advancement Programs, this is a required or elective course in the following Programs:

• Biostatistics (controlled trials) - required

Course Program:

The course is structured as follows

The Instructor:

Dr. Mark Chang is Director of Biostatistics at Millenium Pharmaceuticals, and he has years of teaching experience. He co-authored the book Adaptive Design Methods in Clinical Trials in 2006 and authored the course text Adaptive Design Theory and Implementation Using SAS and R. As the director of Biostatistics, his involvements in drug development at Millennium includes both strategic and methodological aspects. As a technical resource in the biostatistics department at Millennium, he has led and conducted numerous computer simulations for both classic and adaptive clinical trials and provided quantitative assessments for clinical development programs to assist in decision making.

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 10-15 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 Professional Advancement Program 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:

Apr. 18 - May. 16, 2008
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 10-15 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 Introduction to Biostatistics, as well as the material covered in Clinical Trial Design.

Course Text:

The required text is Adaptive Design Theory and Implementation Using SAS and R, by Mark Chang, published by CRC Press. You may order it from the CRC Press website by clicking here, or you may use this discount form. CRC Press usually gives a subhstantial discount when the book is ordered using the above form. Please be sure you obtain your copy before the start of the course.

Software:

The course uses SAS and R; SAS macros and R functions will be provided.

Registration:

Register Online - $449
Register Online (academic) - $349 (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.

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.