Principles and practice of clinical research / edited by John I. Gallin, Frederick P. Ognibene.

Includes bibliographical references and index.

A historical perspective on clinical research -- Ethical principles in clinical research -- Researching a bioethical question -- Integrity in research : Individual and institutional responsibility -- Institutional review boards -- The role of independent institutional review boards -- The regulation of drugs and biological products by the Food and Drug Administration -- Data management in clinical trials -- Data and safety monitoring -- Unanticipated risk in clinical research -- Legal issues -- Rules to prevent conflict of interest for clinical investigators conducting human subjects research -- National Institutes of Health Policy on the inclusion of women and minorities as subjects in clinical research -- Accreditation of human research protection programs -- The role and importance of clinical trial registries and results databases -- The clinical researcher and the media -- Clinical research : A patient perspective -- Design of observational studies -- Design of clinical studies and trials -- Issues in randomization -- Hypothesis testing -- Power and sample size calculations -- An introduction to survival analysis -- Intermediate topics in biostatistics -- Measures of function and health-related quality of life -- Large clinical trials and registries--Clinical Research Institutes -- Meta-analysis of clinical trials -- Using large datasets for population-based health research -- Development and conduct of studies -- Overview of technology development -- Patents and patent licenses -- Writing a protocol -- Evaluating a protocol budget -- Clinical research data : Characteristics, representation, storage, and retrieval -- Management of patient samples and specimens -- Getting the funding you need to support your research : Navigating the National Institutes of Health peer review process -- Clinical research from the Industry perspective -- Philanthropic sector support for medical research and training : History and trends -- Managing clinical risk and measuring participants' perceptions of the clinical research process -- Integration of specialized research services into clinical laboratory operations -- Imaging in clinical trials -- Role of blood bank and transfusion medicine in clinical research -- Clinical pharmacology and its role in pharmaceutical development -- Career paths in clinical research -- Clinical research nursing : A new domain of practice -- Clinical research applications of health disparities science in community settings -- Issues and challenges for clinical research in international settings-- The power of an undiagnosed diseases program in a clinical research enterprise -- Human genome project, genomics, and clinical research -- Harnessing information using genomic platforms.

"The 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"--Publisher's description.

Online resource; title from resource home page (ScienceDirect, viewed October 26, 2015).