- South Africa
- Hong Kong
- New Zealand
- Czech Republic
- United Kingdom
Policies, Positions & Case Studies
Pfizer has created the following position papers, policies and case studies to ensure and demonstrate its ethical development of new medicines. Indeed, all of our clinical research must be reviewed by a qualified Independent Ethics Committee or Institutional Review Board.
We strive to maintain the highest ethical, scientific, and clinical standards in all our clinical research around the world. We regularly review our science policies to align them with Pfizer's vision, values, and goals, and with our stakeholders' evolving values.
- Compassionate Use of Unapproved Investigational Product
- Compensation to Human Research Subjects in Clinical Studies
- Compensation to Investigators in Clinical Studies
- Global Standards for Interventional Clinical Studies
- Public Disclosure and Authorship
- Pfizer's Stem Cell Research Policy
- Use of Human Tissue
- Pfizer Guidelines and Policy on Laboratory Animal Care
Conduct of Clinical Studies
Read Pfizer's statement on the Declaration of Helsinki and the Ethical Conduct of Clinical Studies.
Mulitinational Clinical Trials
Inclusion of emerging markets in development has been ongoing for more than 10 years. This has reduced development times for new medicines, increased knowledge transfer and scientific collaboration, and improved access to new therapies. Learn more about how Pfizer ensures our trials are done ethically and to international standards.
- View our position paper: Globalization of Clinical Trials
NIH Databank position
IRB Accountability position
GCP and HSP Training
Charging for Investigational Drugs
Phase I Trials
Below are 12 case studies illustrating ethical challenges in the conduct of international clinical research and Pfizer's approach. This series of studies is designed to address topics arising throughout the research process:
Before a Clinical Trial
During a Clinical Trial
|Quality Management in Clinical Trials|
|Cultural Issues in Informed Consent|
|Informed Consent: Why and How?|
|Malaria Treatment: Better than the Standard of Care|
After a Clinical Trial and the Overall Environment
|Research on Research: Learning about Phase 1 Trials|
|Partnering for HIV Prevention — The Case of Maraviroc|
|Disclosure of Clinical Trials Information|
|Developing a Stem Cell Research Policy|
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.
- Reviewing Clinical Trials: A Guide for the Ethics Committees (English)
- Reviewing Clinical Trials: A Guide for the Ethics Committees (Spanish)
- Reviewing Clinical Trials: A Guide for the Ethics Committees (Portugese)
- Reviewing Clinical Trials: A Guide for the Ethics Committees (Mandarin Chinese)
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.