Pfizer Becomes The First Pharmaceutical Company To Be Accredited For Protection Of Human Rights In Clinical Research
Fri, 04/03/2009 - 9:28am
NEW YORK-- (BUSINESS WIRE) — Pfizer Inc announced today that it has become the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) for ensuring the protection of human subjects taking part in early-stage clinical trials. The AAHRPP accreditation was awarded to Pfizer's clinical research units (CRUs) in New Haven, CT, Brussels, Belgium and Singapore, where the company conducts most of its Phase I clinical research. To earn the accreditation, Pfizer participated in a rigorous, 15-month examination of the clinical research practices at these units. AAHRPP is an independent, non-profit accrediting body that promotes ethically sound research of the highest quality. Organizations seeking accreditation must provide tangible evidence - through policies, procedures, and practices - of their commitment to ensure human rights protection in clinical research. "Pfizer is committed to upholding the highest ethical standards in all of our clinical research activities," said Martin Mackay, PhD, president of Pfizer Global Research & Development. "AAHRPP accreditation is tangible evidence of our continuing commitment to maintain the highest global standards for research by protecting the human rights of the individuals who take part in our early-stage clinical trials." CRUs and Phase I Research Pfizer allowed AAHRPP to audit its three CRUs and demonstrated that these facilities met the high quality and ethical standards set by AAHRPP including requirements for research set by the International Conference on Harmonization (ICH), as well as research regulations in the United States, European Union and Singapore. The process included site visits, interviews and an application for accreditation that exceeded 1,000 pages. Pfizer's CRUs are staffed by doctors and other health professionals who maintain close ties with nearby hospitals to advance scientific knowledge and share best practices. Phase I trials are the first studies of an investigational drug in humans. In these trials, small doses of an investigational medicine are administered under close medical supervision to healthy volunteer subjects. This allows researchers to measure responses to the investigational medicine, determine how it is absorbed by the body and how long it remains in the bloodstream, and assess the safety and tolerability of different doses. "Safety and scientific excellence are the constant themes of our work," said Rachel Harrigan, MD, Pfizer's senior vice president of Development Operations. "This accreditation acknowledges the commitment of Pfizer's physicians and other staff to the well-being of our volunteers and to our efforts to conduct the highest quality clinical trials at all stages." Pfizer voluntarily sought accreditation to demonstrate its commitment to integrity in research and because it wanted to be among more than 150 of the world's best universities, hospitals, institutional review boards (IRBs) contract research organizations (CROs), and other organizations that are AAHRPP-accredited. Pfizer worked closely with IRBs and ethics committees in New Haven, Brussels and Singapore, all of which invested considerable effort to evolve their standard procedures and methods of review for Pfizer studies in order to meet AAHRP standards. "We are very pleased that Pfizer took a leadership position by demonstrating its commitment to human research protections by seeking and successfully achieving AAHRPP Accreditation," said FelixKhin-Maung-Gyi, PharmD, chief executive officer of Chesapeake Research Review, an AAHRPP-accredited independent IRB based in Maryland. "I hope all others in the research enterprise, including fellow independent IRBs, sponsors, research institutions and sites, and CROs will follow Pfizer's lead. "While many companies strive for excellence in this area, there is no substitute for AAHRPP accreditation to cement the American public's trust in our partnership for conducting clinical trials," Dr. Khin-Maung-Gyi added. "It is our shared responsibility to those who both participate in and rely upon results from these trials to devote the necessary and appropriate resources for high quality, ethical research."