Pfizer Inc. announced Friday that three of its worldwide clinical research units, including one in Connecticut, are the first in the pharmaceutical industry accredited for ensuring the protection of humans taking part in early drug-testing trials.
Pfizer said its clinical-trial programs in New Haven, Belgium and Singapore have been accredited by the Association for the Accreditation of Human Research Protection Programs, which it described as an independent group that promotes ethical research.
Martin Mackay, president of Pfizer Global Research & Development, headquartered in New London, said the accreditation shows the company's “continuing commitment to maintain the highest global standards for research.”
”We are very pleased that Pfizer took a leadership position by demonstrating its commitment to human-research protections,” said Felix Khin-Maung-Gyi, chief executive of Maryland-based Cheseapeake Research Review, a group that reviews the ethics and scientific rigor of institutional research.
Pfizer said more than 150 hospitals, universities and other institutions have been accredited for the ethical conduct of early-stage research, also known as Phase 1. But Pfizer is the first pharmaceutical company to have passed the rigorous requirements for accreditation, the company said.
Phase 1 trials are the first in which new drugs are administered directly to healthy volunteers - in small doses, and under close medical supervision. This allows investigators to determine how humans react to the drug before trying it, in later-stage trials, on specific populations of patients at varying dosages.
In addition to its new accreditation, Pfizer has instituted a number of reforms over the past few years, including registering all its clinical trials on a public database and posting the results of its research as well as issuing updates on its current drug pipeline.
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