Chapter 14: Treatment Effects Monitoring

FDA guidance

• http://www.fda.gov/cder/guidance/959fnl.pdf

NIH policy

• http://grants.nih.gov/grants/guide/notice-files/not98-084.html
• http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

NCI policy

• http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines/page2

Mathematica Program for the Book

• Download File

Conditional power program (file)

• http://www.cancerbiostats.onc.jhmi.edu/software.cfm