Design of Clinical Trials

References 

1. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance, ICH. April 1996;
2. Guidance for Industry E 10 Choices of Control Group and Related Issues in Clinical Trials, ICH. May 2001;
3. Guidance for IRBs, Clinical Investigators, and Sponsors IRB Continuing Review After Clinical Investigation Approval, U.S. Department of Health and Human Services, Food and Drug Administration. January 2010;