Principles and Practice of Clinical ResearchJohn I. Gallin, Frederick P Ognibene The second 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. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government |
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Principles and Practice of Clinical Research John I. Gallin,Frederick P. Ognibene No preview available - 2007 |
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addition adverse events allele analysis application appropriate approval assess award Belmont Report benefit bioethical biological budget cancer case–control Center clinical research clinical trials collaborator conduct conflict of interest CRADA criteria disease document dose drug DSMB enrolled ensure estimate ethical euthanasia evaluate example factors federal felbamate FIAU filing gene genetic grant groups guidelines human subjects hypothesis test identify important individual informed consent Institutes of Health institutional review board intervention invention issues laboratory measures medicine ment meta-analysis methods monitoring multiple myocardial infarction National Institutes null hypothesis outcome p-value participants patients pharmaceutical phase physicians placebo population potential practice prior art protection protocol questions randomized regulations regulatory response risk safety sample scientific scientists sepsis septic shock significant specific sponsor standard statistical study design survival therapy tion treatment effect women