Conducting Clinical Trials
to the Highest Standards
Clinical trials are at the heart of biomedical progress, and we honor volunteers for clinical trials as the unsung medical heroes of our day.
We have always been committed to the highest standards of integrity and conduct in clinical trials, and now we are working to further improve our clinical trial infrastructure. Our goal is to make the clinical trial process simpler and better, and to make sure that all of our trials are done to the highest standards, fully protecting the rights and welfare of the trial participants.
Building Quality and Accountability Into Clinical Trials
Late in 2010, Pfizer launched the Clinical Trial Excellence Project, a top-to-bottom re-engineering of our clinical trial process to make sure that quality procedures are built into every step of the way. The project is achieving its milestones and is expected to complete in late 2012. When complete, it will give us additional state-of-the-art capabilities to help ensure patient safety, data integrity and full compliance with ethical and regulatory standards for clinical research.
To improve efficiency and accountability, we have established strategic partnerships with the respected global firms, Icon and PAREXEL, for clinical trial implementation services. We will be moving 200 of our existing 800 ongoing trials to Icon and PAREXEL, and all future trials will be handled in collaboration with them.
We are committed to leading the efforts for transparency in clinical trials. As of December 2011, we have registered more than 2,500 studies to clinicaltrials.gov.
Transparency in Clinical Trials by the Numbers
80,000 +
Monitoring Visits
80,000+ monitoring visits conducted at clinical trials sites around the world in 2011
100+
Data-Monitoring
Committees
100+ data-monitoring committees overseeing the safety of Pfizer trials around the world.
2,000
Colleagues
2,000 clinical and medical colleagues sharing responsibillity for clinical trials
2,500+
Trials Registered
2,500+ clinical trials registered to clinicaltrials.gov
Global Standards
Clinical trials are not executed directly by Pfizer but rather through independent investigators. We are responsible, however, for making sure that we have clear policies and procedures in place for these investigators, and that they fully understand their responsibilities to the clinical trial volunteer. We continue to expand the diversity of the people involved in our clinical trials as that improves our knowledge of the safety and efficacy of our medicines. To date, Pfizer has executed clinical trials in more than 60 countries.
Wherever we operate, our clinical trial policies and processes require that informed consent, independent ethics reviews, post-study care and the use of placebos conform to well-established international ethical standards.
To ensure informed consent, we have invested in programs such as "speaking books" that illustrate the advantages and disadvantages of clinical trial enrollment in simple-to-understand local language, backed by illustrations.
We also build local capacity worldwide, providing training in good clinical practice to all investigators and all sites. We have developed a certification program for our clinical research staff and contractors, and more than 2,500 of them have successfully completed this program.
Wherever we conduct clinical trials, we do so in accord with consistently applied, constantly reviewed ethical and patient review standards. We sponsor a number of initiatives to help the independent investigators who enroll patients in and manage clinical trials.
Diversity in Clinical Trials
Diversity in clinical trials helps illuminate the factors that cause differences in disease rates and paves the way for more effective medicines and medical procedures. We actively encourage and seek out participants who represent the full spectrum of humanity.
2011 Highlights
- Launched a "speaking book," Safe Use of Medicines, in Uganda and Senegal. Designed specifically for sub-Saharan Africa, the book requires no understanding of written words. It features a combination of colorful pictures, text and sound. The book is available in both English and French and the recorded voices are local. Each page has a button to press to hear the text read out loud.
- Created a "speaking book" for the IPTp Malaria Trial to help support the process of informed consent.
- In a first for the industry, all Pfizer Clinical Research Units were accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
- Commissioned, and saw completed, a clinical trial manual, "Reviewing Clinical Trials: A Guide for the Ethics Committee," authored by experts from the University of Hong Kong, the AAHRPP and leading bioethicists from around the world. Over 1,800 people from more than 80 countries downloaded it when launched, and it has since been translated into Chinese, Spanish and Portuguese.
- Pfizer Global Health Fellows are working with AAHRPP to improve ethical research standards in China.
- In collaboration with the Steve Biko Bioethics Centre, trained researchers and research ethics committee members from eight African countries in the ethical and legal responsibilities involved in research participant protections, research conduct and reporting, and research ethics review processes.
