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Title: Indiana - Issues in Clinical Trials

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Title Indiana - Issues in Clinical Trials
Contributor/Contact Chandon Saha, PhD
Institution Indiana
Acknowledgment Please cite the appropriate contributors/authors/contacts when using or adapting these materials.
Format PDF slides
Attachment Issues in Clinical Trials

Type of Course Single Presentation
Level of Course Mid-level
Audience Clinical Researcher
Topics Description Biostatistics Course for Health Care Providers: A Short Course

* Become familiar with the features of a well-designed clinical trial and common clinical trial designs

* Understand steps in data analysis and presentation of results
Software Program



Keywords Definition of a clinical trial
Phase I clinical trial
Phase II clinical trial
Phase III clinical trial
Phase IV clinical trial
Dose-finding trial
Comparative efficacy
Post-marketing observational studies
Three basic ethical principles:
Clinical trial design
Features of well-designed clinical trials
Phase I design
Comparative Study (Phase III) design:
Two groups parallel study
Cross-over trials
Randomization using permuted blocks
Sample size determination
Monitoring a clinical trial
Group-sequential methods:
Pocock method
O'brien-Fleming design
Descriptive statistics
Statistical inference
Components of a study report
Deficiencies in trial reporting
Deficiencies in reporting of results
Deficiencies of editorial standards
See Also

Type of Activity Course Slides
Disclaimer The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.
Topic revision: r3 - 08 Oct 2012 - 14:44:24 - MaryBanach

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