Everything Hertz

55: The proposal to redefine clinical trials

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Sinopsis

In this episode, Dan and James discuss the US National Institutes of Health's new definition of a “clinical trial”, which comes into effect on the 25th of January. Here’s the new definition: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioural outcomes”. Over the course of this episode, they cover the pros and cons of this decision along with the implications for researchers and science in general. Here are a few things they cover: The traditional definition of a clinical trial We go through James’ old work to determine if he’s been a clinical trialist all along The lack of clarity surrounding the new definition Why are adopting a clinical trial approach when this approach has obvious weaknesses? What do you actually have to do when running a clinical trial? Will institutions also adopt this new definition, thus putt