It’s got to be more than just “sign here.” And it’s about time.
The IOM report on ethical and scientific issues in post-marketing drug safety studies could very easily get lost in the frenzy over you-know-what. That would be a shame because its real value lies in an intelligent and thoughtful outline of how to restructure informed consent. And in our age of the digitally empowered healthcare consumer, this is welcome news
"When a substantial amount of information indicating that a drug to be studied may involve serious safety risks has already accumulated, there are heightened obligations to ensure that potential participants understand the risks posed by study enrollment," the IOM Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs says in a letter report.
The IOM says the emphasis given to risk information in the informed consent process should increase with the severity of risk and the level of certainty about the causal connection between a drug and the adverse outcome. "At a minimum, risks that should be disclosed should include any black box warnings, the 'major statement' currently listed in television advertisements, any adverse event findings of an FDA advisory committee, and a summary of evidence from published peer-reviewed studies."
The committee notes that in addition to verbal disclosures and written consent documents, there is a growing set of additional tools, such as videos and interactive electronic presentations that can enhance potential study participants' understanding of risks they may face.
Bravo.
"Whatever efforts are employed to communicate with potential participants, it is key that they include information that is useful to participants about where the weight of the evidence falls with regard to serious risks and the level of confidence that experts have in drawing conclusions about the risks," IOM says.
Potential study subjects should understand how treatment they will receive in the study differs from the current standard of care. "This is particularly crucial in cases in which medical practice has shifted away from prescribing the study drug because accumulating evidence from passive surveillance, observational studies and small trials or meta-analyses suggests that another therapy is as effective and has a more favorable safety profile," IOM says.
And, of course, FDA must assure that the post-marketing study is appropriately designed to answer the public health questions at issue and minimize risk to participants. Risks should be judged acceptable by FDA, data safety monitoring boards and institutional review boards and the study and subjects should be continuously monitored. As always – but it’s certainly worth repeating.
“Ignorance is never better than knowledge”
-- Enrico Fermi
