Shah et al. recently published in Cancer Discovery results from the NUTRIVENTION trial, a single-arm dietary intervention study in patients with myeloma precursor disorders. While the research question is clinically important and the comprehensive biomarker assessment commendable, several methodological limitations warrant careful consideration before interpreting the findings as evidence for dietary intervention efficacy. Concerns regarding the single-arm design precluding causal inference, inadequate control for multiplicity across dozens of endpoints, inappropriate dichotomization of continuous outcomes, post-hoc subgroup analyses, and regression to the mean in trajectory analyses. Am I thinking right about this study? Please advise. We can design better studies in my opinion. I am a novice, so seeking opinions from the group here
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Short answer: yes!
Inappropriate use of single arm designs (and over-interpretation of results from them) is a major problem in cancer, that seems to be very under-appreciated.
The other issues you mention are kind-of secondary to this.
I’ll try to take a look at the study and comment in more detail.
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Can’t access it apparently so not able to look in more detail at the moment