Principles and Practice of Clinical ResearchThe third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.
|
What people are saying - Write a review
We haven't found any reviews in the usual places.
Contents
Part II Biostatistics and Epidemiology
| 205 |
Part
III Technology Transfer Protocol Development and Funding | 395 |
Part
IV Clinical Research Infrastructure | 571 |
| 745 | |
Other editions - View all
Principles and Practice of Clinical Research John I. Gallin,Frederick P. Ognibene Limited preview - 2012 |
Principles and Practice of Clinical Research John I. Gallin,Frederick P Ognibene Limited preview - 2011 |
Common terms and phrases
adverse events agency analysis appropriate assess Bayh-Dole Act benefit bias biological cancer Center Chapter clinical research clinical studies clinical trials ClinicalTrials.gov collaborator conduct confidence interval conflict of interest CRADA criteria disease documents drug DSMB efficacy enrolled ensure ethical evaluate example factors federal felbamate FIAU funding guidelines human subjects hypothesis test important independent IRBs individual informed consent infringement Institutes of Health Institutional Review Board intervention invention investigators involved issues license measures Medicine ment meta-analysis methods monitoring multiple myocardial infarction National Institutes null hypothesis outcome p-value patent application patients phase placebo population potential practice prior art procedures Program protection protocol publication bias questions randomized regulations regulatory reporting response risk safety sample scientific significant specific sponsor standard statistical study design therapy tion treatment effect type I error USPTO women
Bibliographic information
| Title | Principles and Practice of Clinical Research |
| Editors | John I. Gallin, Frederick P Ognibene |
| Edition | 3 |
| Publisher | Academic Press, 2012 |
| ISBN | 0123821681, 9780123821683 |
| Length | 796 pages |
| Subjects | › › Medical / Pharmacology Science / Life Sciences / Genetics & Genomics Science / Life Sciences / Molecular Biology |
| Export Citation | BiBTeX EndNote RefMan |