BookTom Brody.
Contents:
The origins of drugs
Introduction to regulated clinical trials
Run in period
Inclusion/exclusion criteria, stratification, and subgroups : part I
Inclusion and stratification criteria : part II
Randomization, allocation, and blinding
Placebo arm as part of clinical study design
Intent to treat analysis vs. per protocol analysis
Biostatistics
Introduction to endpoints for clinical trials in pharmacology
Endpoints in clinical trials on solid tumors : objective response
Oncology endpoints : overall survival and progression free survival
Oncology endpoints : time to progression
Oncology endpoint : disease free survival
Oncology endpoint : time to distant metastasis
Neoadjuvant therapy versus adjuvant therapy
Hematological cancers
Biomarkers and personalized medicine
Endpoints in immune diseases
Endpoints in clinical trials on infections
Health related quality of life
Health related quality of life instruments for immune disorders
Health related quality of life instruments and infections
Drug safety
Mechanism of action : part I
Mechanism of action, part II : cancer
Mechanism of action, part III : immune disorders
Mechanisms of action, part IV : infections
Consent forms
Package inserts
Regulatory approval
Patents.