Principles and practice of clinical research

TitlePrinciples and practice of clinical research
Publication TypeBook
Year of Publication2007
AuthorsGallin, JI
Pagination430 p.
PublisherAcademic Press
Publication Languageeng
ISBN Number012369440X
Accession Number49673503
KeywordsBIOLOGY , Clinical , Forschung. , GENETICS , Médecine , MEDICINE , Medizin. , Recherche , research , responsible conduct of research
AbstractThe 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.
Notesill. ; 29 cm.A historical perspective on clinical research / John I. Gallin -- Ethical principles in clinical research / Christine Grady -- Researching n bioethical question / Ezekiel J. Emanuel -- Integrity in research: individual and institutional responsibility / Alan N. Schechter -- Institutional review boards / Alison Wichman and Alan L. Sandler -- Data and safety monitoring boards / Lawrence M. Friedman -- Data and clinical management clinical trials / Jane Cassidy -- Unanticipated risk in clinical research / Stephen E. Straus -- The regulation of drugs and biological products by the Food and Drug Administration / Kathryn C. Zoon and Robert A. Yetter -- Legal issues / Patricia A. Kvochak -- NIH policy on the inclusion of women and minorities as subjects of clinical research / Eugene G. Hayunga and Vivian W. Pinn -- An introduction to biostatistics: randomizations, hypothesis testing, and sample size / Paul S. Albert and Craig B. Borkowf -- Design and conduct of observation studies and clinical trials / Teri A. Manolio -- Small clinical trials / Mitchell B. Max -- Large clinical trials: clinical research institutes / Robert M. Califf -- Using secondary data in statistical analysis / Bradley D. Freeman, Eric P. Gerstenberger, Steven Banks, and Charles Natanson -- An introduction to survival analysis / Joanna H. Shih -- Measures of function and health-related quality of life / Lynn H. Gerber -- Economic analysis and clinical research / Martin L. Brown, Keven B. Knopf, Stephen E. Marcus, and Joseph Lipscomb -- Overview of technology development / Bruce Goldstein -- Technology transfer / James Clifford Haight -- Telemedicine systems / Kenneth M. Kempner, Frank S. Govern, and Robert Martino -- Animal models of human disease / Domenico Accili -- Conducting and evaluating clinical research on complementary and alternative medicine / Wayne B. Jonas and Klaus Linde -- Preparing scientific images for publication and display / Christopher Vargas -- Writing a clinical protocol: the mechanics / Eddie Reed and Antoinette Jones-Wells -- Getting the funding you need to support your research: successfully navigating the NIH peer review process for grants / Olivia T. Preble Bartlett and Elliot Postow.Table of contents
URLMaterials specified: Publisher description
Full Text