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 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

The Instructor:

Dr. Mark Chang has over 13 years of experience as a statistician in the field of clinical trials. In addition, he has over 4 years of teaching experience as assistant professor. He recently joined AMAG Pharmaceuticals as the executive director and leads the department of biostatistics and data management. Before he joined AMAG, Chang held various positions in Millennium Pharmaceuticals, including Director of biostatistics and Scientific Fellow. His involvement in drug development at Millennium Pharmaceuticals includes both strategic and methodological aspects. He is a co-founder of the International Society for Biopharmaceutical Statistics, an executive member of ASA Biopharmaceutical Section, and a member of Expert Panel for the Networks of Centres of Excellence (NCE) Canada. He is a co-chair of Biotechnology Industry Organization (BIO) Adaptive Design Working Group. Dr. Chang severs on the Editorial Board for the Open Public Health Journal and is an associate editor for the Journal of Biopharmaceutical Statistics with over 40 publications including three books on adaptive designs. He has been invited to serve as a co-chair, on the scientific advisory and organization committees for national and international professional/academic conferences on statistics and clinical trial designs.

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:

Apr. 16 - May. 14, 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 Introduction to Biostatistics, as well as the material covered in Avoiding Selection Bias in Randomized Clinical Trials.

Course Text:

The main text is Adaptive Design Theory and Implementation Using SAS and R(2006), published by CRC Press can be ordered here or to receive a 20% discount from CRC Press, you may order with this discount form.

The supplementary text, which includes software, is Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio, by Mark Chang, published by Wiley and it can be ordered directly from the publisher here. Enter the code aff15 in the Promotion Code field when prompted during checkout and click the Apply Discount button. Wiley typically offers statistics.com customers up to 15% discount on all statistics titles. (If you are located in Asia, the web procedure for your location may not accept this discount -- try calling your regional Wiley representative.)

Software:

Illustrations are provided in ExpDesign, which comes bundled with the 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 - $469
Register Online (academic) - $369 (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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