Clinical Trial Design, Human Subject Protection & GCP
Written by the Director of the Clinical Trial Centre of the University of Hong Kong and edited by him and the President & CEO of the Association for Accreditation of Human Research Protection Programs (AAHRPP), this manual was sponsored by Pfizer to help acquaint new research ethics committee members about clinical trial design, human subject protection, and good clinical practice (GCP) requirements. The manual addresses research ethics and global standards for clinical trials. The author-editors, Professor Johan Karlberg and Dr. Marjorie Speers, reviewed the contents of this manual with a board of leading experts in research ethics.
Globalization and Multi-Regional Clinical Trials
This concept paper describes ideas in progress, discussed at a January 2010 Summit Meeting convened by Pfizer, across five domains: research ethics committees/trial review, data and safety monitoring, site and investigator selection, site monitoring, and improving clinical trial agreements. Pfizer funded this work to address challenges associated with the globalization of clinical research. The Project has involved experts from large and small companies, clinical research organizations, non-industry sponsors of research, non-industry researchers and bioethicists, and other stakeholders. Opportunities to enhance the planning and conduct of multi-regional trials especially multi-regional clinical trials (MRCTs) involving developing-world countries, are described in the attached report.