fizer has announced that it is the first pharmaceutical company to be recognised by the US-based Association for the Accreditation of Human Research Protection Programs (AAHRPP) for ensuring the protection of human subjects in Phase I clinical trials.
The announcement is timely, given the renewed attention to Pfizer’s informed consent procedures in emerging markets. There are reports that the company has reached an out-of-court settlement over its notorious Trovan (trovafloxacin) antibiotic trial thirteen years ago in Nigeria, which was claimed to be responsible for the deaths of 11 children.
AAHRPP accreditation was awarded to Pfizer’s clinical research units (CRUs) in New Haven (US), Brussels (Belgium) and Singapore, where the company conducts most of its Phase I trials. The seal of approval followed a “rigorous” 15-month review of Pfizer’s clinical research practices at these units, involving site visits, interviews and a more than 1,000-page application for accreditation, Pfizer noted.
The company sought the accreditation voluntarily “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, contract research organisations and other organisations that are AAHRPP-accredited”, Pfizer said.
It had to demonstrate that the CRUs met the standards set by the independent, non-profit accrediting body, which include International Conference on Harmonisation (ICH) requirements and research regulations applied in the US, the European Union and Singapore.
“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,” stated Dr Martin Mackay, president of Pfizer Global Research and Development.
According to the company, its ongoing efforts to earn public trust for integrity in research also include:
- requiring all Pfizer-sponsored clinical trials – regardless of where they are carried out – to meet the same international standards, including the ICH’s 1996 Guidelines for Good Clinical Practice and the global principles set forth in the Declaration of Helsinki;
- building infrastructure for clinical research in emerging markets, in partnership with local authorities and research institutions;
- conducting training programmes for good clinical practice around the world; and
- since November 2008, requiring that all multicentre trials conducted by Pfizer in the US are reviewed only by central IRBs that are AAHRPP-accredited.