Principles and practice of clinical research /
Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research. This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, proto...
Clasificación: | Libro Electrónico |
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Autor principal: | |
Formato: | Electrónico eBook |
Idioma: | Inglés |
Publicado: |
San Diego, CA :
Academic Press,
2002.
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Temas: | |
Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Preface.
- Acknowledgements.
- Historical Perspective and Introduction.
- Part I: Ethical, Regulatory and Legal Issues
- Ethical Principles in Clinical Research.
- Researching a Bioethical Question.
- Integrity in Research: Individual and Institutional Responsibility.
- Institutional Review Boards.
- Data and Safety Monitoring Boards.
- Data and Data Management in Clinical Trials.
- Unanticipated Risk in Clinical Research.
- The Regulation of Drugs and Biological Products by the Food and Drug Administration.
- Legal Issues.
- NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research.
- Part II: Biostatistics and Epidemiology
- An Introduction to Biostatistics: Randomization, Hypothesis Testing and Sample Size.
- Design and Conduct of Observational Studies and Clinical Trials.
- Small Clinical Trials.
- Large Clinical Trials Clinical Research Institutes.
- Using Secondary Data in Statistical Analysis.
- An Introduction to Survival Analysis.
- Measures of Function and Health Related to Quality of Life.
- Economic Analysis and Clinical Research.
- Part III: Technology Transfer, Protocol Development and Funding
- Overview of Technology Development.
- Technology Transfer.
- Telemedicine Systems.
- Animal Models of Human Disease.
- Conducting and Evaluating Clinical Research on Complementary and Alternative Medicine.
- Preparing Scientific Images for Publication and Display.
- Writing a Clinical Protocol The Mechanics.
- Navigating the Peer Review Process for Grants.
- 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.