Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond?

The US Food and Drug Administration is focusing its efforts on Institutional Review Boards (IRBs), which approve and monitor clinical trials. The agency recently told a hearing of the House Subcommittee on Oversight and Investigations that it will require IRBs to register with them, beginning in July 2009. The registration process will be the basis for a database of IRBs, and this tool will help FDA monitor and inspect these bodies. The agency also said it would establish voluntary guidelines for drugmakers and IRBs.

FDA was stirred to action when the Government Accountability Office (GAO) reported that it had successfully set up a phony IRB, registered it with the US Department of Health and Human Services, and gotten approval to test an imaginary medical device on human subjects. The GAO also obtained a real IRB’s approval for a fake protocol for human-subjects research, although the protocol contained demonstrably false claims that the device to be tested had FDA approval.

Last week the Association for the Accreditation of Human Research Protection Programs gave Pfizer its accreditation for protecting the rights of its human clinical trial subjects, and the company pledges to carry out trials according to the International Conference on Harmonization’s international standards of good clinical practice. Despite Pfizer’s good will, I think FDA needs binding, not voluntary, rules to ensure that all pharmaceutical companies protect their trial patients’ safety. Human life is precious and demands no less.