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Articles to consider for Clinical Trial Design
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About 10000 clinical trials are undertaken annually in all
areas of medicine, from the treatment of acne to the
prevention of cancer. Correct interpretation of the data
from such trials depends largely on adequate design and on
performing the appropriate statistical analyses. The
statistical aspects of both the design and analysis of
trials are important, with particular emphasis on recently
developed methods of analysis.
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1. Guidance for determining the number of centers in clinical trials
2. Guidelines on Data Safety and Monitoring
This guideline is to provide the oversight and necessity of interim monitoring to ensure the safety of the study participants and the validity and integrity of the trial data. Phase III clinical trials usually have a Data and Safety monitoring Board (DSMB), with broad responsibility for monitoring the conduct of the trial.
3. Guidelines for the Creation of Analysis Data Files and Documentation of Statistical Analyses for Submission
4. Guidance for Contents of the Clinical Study Report
The purpose of this document is to provide guidelines on what information need to be included in statistical section of the Clinical Study Report (CSR).
Oncology: Optimal Two-Stage Designs For Phase II Clinical Trials
Example of this Calculation
| Optimal Two Stage Design | Optimum Design | MinMax Design |
|---|---|---|
| First Stage Sample Size (n1) | ||
| Upper Limit For 1st Stage Rejection of Drug (r1) | ||
| Maximum Sample Size (n) | ||
| Upper Limit for 2nd Stage Rejection of Drug (r) | ||
| Expected Sample Size If Response Probability = P0 | ||
| Probability of Early Termination at P0 |
Publisher & Author: Dave Hamadani
