Clinical Trial Design
Dr. Vance W. BergerAim of Course:
This course covers the essential concepts required to design rigorous randomized trials so as to avoid selection bias and ensure valid treatment comparisons. The nature and objectives of randomization are discussed, as are masking, allocation concealment, blocking, stratification, dynamic randomization, and the various types of selection bias that can arise. In addition, we cover analysis techniques that can be used to salvage reliable treatment comparisons even if some of these selection biases are detected. These methods are more advanced, and involve adaptations of the propensity score.Who Should Take This Course:
Anyone who designs, conducts, analyzes, or reviews randomized clinical trials. This includes research staff in pharmaceutical and biotechnology firms and CROs, regulators, journal editors, and students of biostatistics and epidemiology.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 followsSESSION 1: Clinical trial designs - A hierarchy
- The need for comparison groups.
- Historical vs. parallel comparison groups.
- Self-selection vs. physician treatment decision vs. randomization.
- Masking and allocation concealment.
SESSION 2: Detecting violations of the randomization procedure
- Baseline comparisons by treatment groups.
- Baseline comparisons by P{E} groups.
- The Berger-Exner test and graph.
SESSION 3: Preventing subversion of the trial (by violations of randomization)
- Permuted blocks with fixed or varied block size.
- The maximal procedure.
- Unrestricted randomization and chronological bias.
SESSION 4: Salvaging trials affected by violations of randomization
- Excluding data from contaminated centers.
- Excluding data from patients with predictable allocations.
- Using the RPS as a covariate.
SESSION 5: Crossover Designs
- Washout period.
The Instructor:
Dr. Vance W. Berger serves on the adjunct faculty of the University of Maryland Baltimore County. He is the author of Selection Bias and Covariate Imbalances in Randomized Clinical Trials (John Wiley and Sons, 2005), and has written or co-written dozens of papers in peer reviewed journals in medicine and statistics. He has also taught in the past at Rutgers University and the Johns Hopkins University School of Public Health, reviews manuscripts for many of the top scholarly journals, has lectured all over the country on his research, and has served as an FDA reviewer for over four years.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 5 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:
Sep. 19 - Oct. 24, 2008Click 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:
IntermediatePrerequisite:
The equivalent of Introduction to Statistics I: Inference for a Single Variable, and Introduction to Statistics II: Working with Bivariate Data (and, if necessary before these courses, Introduction to Statistics for Beginners or Survey of Statistics for Beginners). This should be followed by a course in the basics of biostatistics, such as would be provided by Introduction to Biostatistics.Course Text:
The required text is Selection Bias and Covariate Imbalances in Randomized Clinical Trials by Vance W. Berger. This text can be purchased directly from Wiley here . Wiley typically offers statisics.com customers discounts of up to 15%. PLEASE ORDER YOUR COPY IN TIME FOR THE COURSE STARTING DATE.Software:
NoneRegistration:
Register Online - $449Register 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.