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In this episode, Dan and James discuss the US National Institutes of Health's new definition of a \u201cclinical trial\u201d, which comes into effect on the 25th of January.

Here\u2019s the new definition: \u201cA 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\u201d.

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:

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• The traditional definition of a clinical trial
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• We go through James\u2019 old work to determine if he\u2019s been a clinical trialist all along
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• The lack of clarity surrounding the new definition
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• Why are adopting a clinical trial approach when this approach has obvious weaknesses?
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• What do you actually have to do when running a clinical trial?
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• Will institutions also adopt this new definition, thus putting basic research through clinical trial IRBs?
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• What if this extra red tape actually improves science?
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• One argument against the proposal is that registering more studies on clinicaltrials.gov will confuse the public. We don\u2019t buy that.
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• Clinical trial registrations generally miss the many nuances of study design
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• The new clinical trial definition will eliminate some of the \u2018forking paths\u2019 when analysing and reporting data
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• How this new definition will affect grant applications for early career researchers?
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• What happens to exploratory research?
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• NIH case studies of what may constitute a clinical trial
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Links

NIH clinical trial definition https://grants.nih.gov/policy/clinical-trials/definition.htm
\nThe NIH \u201cclinical trial decision tree\u201d https://grants.nih.gov/policy/clinical-trials/CT-decision-tree.pdf
\nNIH case studies of what may constitute a clinical trial https://grants.nih.gov/policy/clinical-trials/case-studies.htm#case1

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