Principles and practice of clinical research

Description

This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.  Read more... 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.