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Adaptive Designs for Clinical Trials
Instructor(s): Dates:March 21, 2014 to April 18, 2014
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Adaptive Designs for Clinical Trials
taught by Vidyadhar Phadke
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.
Course Program:SESSION 1:
- General Concept
- Fundamental Theory
- Group Sequential Design
- Adaptive Interim Analysis in Clinical Trials
- Adaptive Dose Finding Design
- Enrichment Design for Target Clinical Trials
- Two-Stage Adaptive Design
- Sample size estimation/allocation
- Protocol Amendments
- Clinical Trial Simulation
- Efficiency of Adaptive Design
- Case Studies
HOMEWORK:
Homework in this course consists of short answer questions to test concepts, guided data analysis problems using software, and guided data modeling problems using software.
Adaptive Designs for Clinical Trials
Instructor(s):
Dates:March 21, 2014 to April 18, 2014
Course Fee: $499
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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. Those registering for multiple courses, Statistics.com's PASS students, and those affiliated with other academic institutions may be entitled to tuition discounts; read more.
Have you reviewed the REQUIREMENTS for this course?Adaptive Designs for Clinical Trials
taught by Vidyadhar Phadke
Who Should Take This Course:Statisticians with responsibility for designing, analyzing and reporting clinical trials.
Level:Intermediate/Advanced
Organization of the Course:This course takes place online at the Institute 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 at the end of the week, you will receive individual feedback on your homework answers.
Credit:
Students come to the Institute for a variety of reasons. As you begin the course, you will be asked to specify your category:
- You may be interested only in learning the material presented, and not be concerned with grades or a record of completion.
- You may be enrolled in PASS (Programs in Analytics and Statistical Studies) that requires demonstration of proficiency in the subject, in which case your work will be assessed for a grade.
- You may require a "Record of Course Completion," along with professional development credit in the form of Continuing Education Units (CEU's). For those successfully completing the course, 5.0 CEU's and a record of course completion will be issued by The Institute, upon request.
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.
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"Our company is coming to the end of our first year working with statistics.com as its primary provider of statistical training and I wanted to thank you for the excellent classes and overall service that you have provided. The classes have been consistently on target and provided a foundation that have allowed my team to take their new skills and immediately implement them in research efforts. My research team is significantly more skilled and efficient than they were at the beginning of the year. They have used their training to complete predictive models, a segmentation of the consumer market and a conjoint evaluation.
It took me a long time to find a program that provided the right mix of applied and theory, but I have finally found the right one. My staff emerges from your training ready to make an impact on the company.
As you know, we are now getting ready to send a second wave of researchers through your training.
I also have to note that your administrative staff makes the process of registering and tracking our classes seamless. I wish all training efforts could run this smoothly.
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