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Final report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada.

Author: National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada.; National Placebo Initiative (Canada); Canadian Institutes of Health Research.
Publisher: Ottawa, Ont. : Canadian Institutes of Health Research, 2004
Edition/Format:   eBook : Document : EnglishView all editions and formats
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Genre/Form: Electronic books
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada.; National Placebo Initiative (Canada); Canadian Institutes of Health Research.
OCLC Number: 319677377
Notes: "July 2004."
Description: 1 online resource (vii, 90 pages : tables)
Contents: Acknowledgments --
Executive summary --
1. Introduction --
2. The citizen and patient perspectives --
3. Scientific perspectives --
4. Ethical perspective --
5. Legal perspective --
6. Regulatory perspective --
A. Issues relevant to early clinical drug trials --
B. ICH E-10 --
C. Common features of international research ethics and regulatory guidelines --
D. The ethical basis for international research ethics and regulatory guidelines --
E. Recommendation: be consistent with international guidelines --
7. Research Ethics Board perspective --
A. Introduction --
B. Areas of concern --
C. Consideration of a central review process for clinical trials --
D. Recommendations --
8. Recommendations and unresolved issues --
A. Areas of consensus --
B. Unresolved policy issues --
C. Administrative recommendations --
Conclusion/next steps --
Appendix 1 A. Clinical drug development and regulation --
Appendix 1 B. The placebo debate and the major players --
Appendix 2. Acronyms --
Appendix 3. Glossary --
Appendix 4. List of tables --
Appendix 5. Biographical notes of NPWC members.
Other Titles: National Placebo Initiative
Rapport final du Comité de travail national sur les placebos portant sur l'utilisation appropriée des placebos dans les essais cliniques au Canada
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