AP, 2008. - 536 p. ISBN: 0123736951
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.
*Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data.
*Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine.
*Expert authorship whose experience includes running clinical trials in an academic as well as industry settings.
*Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy.
Contents
OverviewOverview of clinical research medicine
Ethical, legal, and regulatory issues
The general structure of clinical trials and programsIntroduction to clinical trial statistics
Measure and variables
Study groups
Periods, sequences, and trial design
Key components of clinical trials and programsEndpoints
Economics and patient reported outcomes
Patient selection and sampling
Dosing and intervention
Epidemiology, decision analysis, and simulation
Conduct of the studyStudy execution
Site selection and patient recruitment
Analysis of resultsAssessing data quality and transforming data
Analysis of data
Data interpretation and conclusions
Appendicies
Index