TY  - GEN
AU  - Brody, Tom
TI  - Clinical Trials: : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
SN  - 9780123919113
U1  - 615 
PY  - 2012///
CY  - Amsterdam : 
PB  - Elsevier/AP
KW  - Clinical trials
KW  -  Drug approval.
N1  - 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
N2  - Suitable for those engaged in clinical trial design, this book details the organizations and content of clinical trials, including trial design, subgroups, HRQoL, consent forms and package inserts. It provides information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature
ER  -