Reviewing clinical trials
Subtitle: a guide for the Ethics Committee
By: editors, Johan PE Karlberg and Marjorie A. Speers
Contributors: Karlberg, J. (Johan); Speers, Marjorie A.; Chinese University of Hong Kong; Chinese University of Hong Kong. Clinical Trials Centre; Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc
Publisher: Karlberg
Published: 2010
Place of publication: Hong Kong, China
Language: eng
Number of pages: 153
ISBN-13: 9789881904119
Subjects: Ethics Committees; Medical Ethics; Clinical Trials as Topic; Human experimentation in medicine; Moral and ethical aspects; Clinical trials; Medical ethics; Ethics; Research; Clinical Ethics Committees; Research Ethics; Clinical Ethics
Other titles: Clinical trials
Description: The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Notes: Also issued online in Pdf via thw World Wide Web.
Table of contents: title: Chapter 1. Introduction. 1.1 Ethics and Bioethics; title: 1.2 Clinical Trials in the Context of Biomedical Research; title: 1.3 Clinical Trial Players and Their Responsibilities; title: - Chapter 2. Features of Clinical Trials. 2.1 Objectives of Clinical Trials; title: 2.2 Clinical Trial Design; title: 2.3 Controls of Clinical Trials; title: 2.4 Clinical Trial Outcome/Endpoint; title: 2.5 Randomisation; title: 2.6 Blinding; title: 2.7 Sample Size; title: 2.8 Trial Phases; title: 2.9 Multicentre Trials; title: - Chapter 3. Science, Ethics and Quality Assurance of Clinical Trials. 3.1 Research in Humans; title: 3.2 Science of Clinical Trials; title: 3.3 Issues of Ethics of Clinical Trials; title: 3.4 Issues of EC Procedures; title: 3.5 Quality Assurance of Clinical; title: 3.6 Human Research Protection Programme Accreditation; title: 3.7 The AAHRPP Accreditation Standards; title: - Chapter 4. Scenarios of Ethics Committee Review; title: 4.1 Introduction to Practical EC Review.