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10/04/2011

A Duty to Report Dead Ends?

When an investigational agent is being studied by pharma, is there an ethical responsibility to disclose the findings of that research, even if the agent is no longer being studied or being brought to market?

At least one researcher, as argued in last week’s Science Translational Medicine and reported in Science Daily, believes that such a moral obligation does exist. Why the duty to disclose dead dead end data?

Because although most clinical trials end because the agent fails to be effective or safe, some studies conducted by industry are halted for reasons having nothing to do with the lack of efficacy or safety. Often new drugs are halted because of onerous regulatory requirements, further study, or a simple lack of “market opportunity,” says the UC Davis researcher.

So how much important clinical data is being tossed aside from which other researchers and future patients could benefit? We’ll never know. And while some study sponsors go ahead and publish dead end data anyway, they are not required to do so. If they were, who knows what we could find out?

Summer Johnson McGee, PhD

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