Designing and Conducting Clinical Trials (for Managers)
Course date: March-2004
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Are you planning for a new clinical trial or are appraising a just-completed one? Statistics.com invites you to participate in a new on-line distance learning course for existing and would-be managers and entrepreneurs of pharmaceutical, medical device, and biologics firms. A Manager's Guide to Design and Conduct of Clinical Trials covers:
Designing trials and determining sample size
Computer-assisted data collection and submission
Exception handling
Monitoring
Budgeting men and materials
Documentation and reports
After action review
Dr. Phillip Good, the seasoned instructor of this four-week internet course, has over twenty years experience in the pharmaceutical and device industry. He is the author of The Manager's Guide to Design and Conduct of Clinical Trials (Wiley, 2003). (The text is available separately to course participants at a 20% discount.) He was the keynote speaker at the 2003 Maastricht conference on "Transnational Clinical Trials." Following a fourteen-point prescription, he will take you through all phases of the design, implementation, conduct, analysis, and after action review of a clinical trial.
An online bulletin board available enables you to interact with the instructor and your fellow students throughout the course and submit your own findings for discussion. All students use aliases and their email addresses and company affiliations are concealed so that the open interchange of ideas is facilitated.
The course should take 5-10 hours per week. Regular visits to the course discussion board are required, but you can arrange these at your own convenience.
Who Should Take This Course - Existing and would-be managers and entrepreneurs of pharmaceutical, medical device, and biologics firms.
The Instructor - Phillip Good, Ph.D., has been providing on-line instruction through the auspices of Statistics.com for three years. He is the author of Common Errors in Statistics and How to Avoid Them (with J. Hardin, Wiley, 2003), Manager's Guide to Design and Conduct of Clinical Trials (Wiley, 2002), Applying Statistics in the Courtroom (CRC, 2001), Resampling Methods (Birkhauser, 2nd ed, 2001), and Permutation Tests (Springer-Verlag, 2nd ed 2000). Nine other books, 600 plus popular articles, 33 scholarly articles, and sixteen of his short stories are also in print. Holder of the Ph.D. and A.B. in Mathematical Statistics from the University of California at Berkeley, he is a former Calloway Professor of Computer Science at the University of Georgia, Division Head and Professor of Biology and Physics at West Coast University, and Associate Professor of Applied Mathematics at Claremont College.
Organization of the Course - The course takes place over the Internet, at statistics.com. Course participants will be given an alias and access to a private bulletin board on which they will receive course materials. The board will also serve as a forum for discussion of ideas and problem solving.
The course is scheduled to take place over four weeks. At the beginning of each week, participants receive the relevant material, in addition to answers to exercises from the previous session. During the week, participants are expected to go over the course materials and work through exercises. Discussion among participants is encouraged. The course leader will provide answers and comments on set weekdays.
The course will be taught in English, given the diversity of background of the participants. However, participants are encouraged to contact the course leader with questions or comments in French, which may be translated and forwarded to the list, whenever relevant.
To enroll - You may register for this course by going to our payment site and entering your credit card information. NOTE: We will not charge your card until one week before the course begins. You can cancel at any time prior to that day.
Register Now for Manager's Guide to Design and Conduct of Clinical Trials or
Register for the discount version
http://www.statistics.com/content/courses/clinicaltrials/index.html
Course Program - The course is structured as follows:
Week 1: Eight Guidelines
Start with your reports
Computer-assisted data entry
Plug the holes as they arise
Monitor person-power
Pay only for results
Lay the groundwork
Plan, do, then check
Week 2: Trial Design
Should the study be performed?
Study objectives
End points
Quality control
Study population
Timing
Closure
Week 3: Monitoring The Trials
Walk through
Site visits
Maintaining investigator interest
Patient retention
Termination and extension
Maintaining the budget
Interim analyses
Week 4. Analyzing the Results
Documentation
Report coverage
Understanding data
Exceptions and adverse events
Equivalence
Bad statistics
After action review
http://www.statistics.com/content/courses/clinicaltrials/index.html
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