© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 20, 1519,
October 16, 2002
© 2002 Oxford University Press
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Would Central Review Streamline the Clinical Trials Process?
Given the lack of structure for risk/benefit decision-making by institutional review boards, should a formal system be put in place to standardize the process?
"I think it would be desirable, but I think it’s unlikely that it’s ever going to happen," said Neil Aaronson, Ph.D., head of the Division of Psychosocial Research and Epidemiology at The Netherlands Cancer Institute in Amsterdam. For multicenter trials in Holland, he said, "a designated IRB reviews a given protocol and gives participating hospitals the option to simply sign off, forgoing their own full review." But the hospitals rarely do so—and at least in part, he said, for good reason.
"It would be irresponsible for any hospital to defer entirely to another body for ethical approval of treatment of their patients," he said. "Furthermore, two centers may come to different conclusions—often, I’ve seen protocols approved by other centers when we have some fairly serious questions."
In a study published in the June 2001 Academic Emergency Medicine, Thomas Stair, M.D., of Brigham and Women’s Hospital and Harvard Medical School, Boston, compared responses of 44 IRBs to a protocol for a multicenter study of outpatient therapy for acute asthma. Although all eventually signed on, more than 90% of the IRBs requested changes to the protocol itself, the consent form, or the logistics and supervision of the study. Some of the requested changes were simple and logical, such as translating consent forms into another language. But others were more drastic.
In the most extreme case, Stair said, one IRB judged that the placebo control arm of the trial was unethical because the treatment being tested was standard care. Another IRB had precisely the opposite response: The experimental arm was unethical because the treatment was too dangerous.
The authors suggest that multicenter trials might be facilitated by a national IRB process that could "review in detail and approve one time the science and design of a multicenter protocol, saving the local IRBs time to review the procedure for patient enrollment and the language of the consent forms, where there may exist more legitimate local variations." The National Bioethics Advisory Commission also recommended the creation of a centralized IRB system in a 2001 report.
Responding to the growth in the number, size, and complexity of cancer clinical trials, the National Cancer Institute has established a pilot program with a central IRB for phase III multicenter trials. The CIRB provides expert scientific review at the national level, facilitating quick review at the local sites. More information about the project is available at http://www.ncicirb.org.
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