A guide to clinical drug research
Author(s)
Bibliographic Information
A guide to clinical drug research
Kluwer Academic Publishers, c1995
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Note
Includes bibliographical references and index
Description and Table of Contents
Description
This work provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It informs investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of "good clinical practice". The text concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and should be relevant to all those involved in clinical research in a variety of settings.
Table of Contents
Foreword/Preface. 1. Clinical Research: From Idea to Publication. 2. Facilities and Equipment. 3. What Does the Investigator Need to Know about the Drug? 4. The First Administration of a New Active Substance to Humans. 5. Planning and Coordinating the Study. 6. The Study Protocol. 7. Study Design. 8. Data Management and Statistical Analysis. 9. Ethical Considerations. 10. Aspects of Study Conduct. 11. Good Clinical Practice. 12. Communicating Clinical Research. 13. Clinical Research in a Developing Country. 14. Computers in Clinical Research. Index.
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