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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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Gallin, John I.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: San Diego, CA : Academic Press, 2002.
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.