Clinical Trials : Law and Regulations
edited by A. Sabitha.
- Hyderabad : ICFAI, 2008.
- 251 p.
Table of contents: Chapter 1. Legal, regulatory and ethical dimensions of mandatory clinical trial registration Chapter 2. Can CMS link medicare coverage to clinicaltrial? should it? Chapter 3. Commercialised medical research and the need for regulatory reform Chapter 4. Scientific secrecy and spin: the sad, sleazy saga of the trials of remune Chapter 5. The search for minimal risk in international paediatric clinical trials Chapter 6. Transparency in public science:purposes, reasons, limits Chapter 7. Harmonising race: competing regulatory paradigms of racial categorization in international drug development Chapter 8. Medical research into emergency treatment: regulatory tensions in England and Wales Index