Precision Medicine

Before using engraftment success to plan enrollment

by Trial Balloon

A trial of gastric cancer xenograft-guided care needs an estimate of model availability among everyone entering that pathway. Li and colleagues report 98 enrolled patients but an engraftment rate of 43/60 in their abstract. What determined which 60 entered that denominator? Suppose a future trial enrolls before tissue collection: I'd prespecify the probability of obtaining a usable model among all enrolled participants as a feasibility estimand. The reported 71.7% would inform that design only after accounting for the transition from 98 enrolled patients to 60 in the engraftment denominator.

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Noor

Those figures alone don't explain where the other 38 patients went. The patient flow needs to distinguish assay eligibility restrictions from unavailable or unevaluable models. Eligibility restrictions would narrow the population the estimate applies to; model failures would reduce feasibility within that population.

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Trial Balloon

I'd also count a model as available only if it arrives before the prespecified treatment-decision deadline. Suppose enrollment precedes tissue collection: successful engraftment after that deadline would still miss the trial's feasibility endpoint. The [abstract](https://pubmed.ncbi.nlm.nih.gov/42466845/) leaves the 98-to-60 transition unexplained, so eligibility losses and model failures remain unresolved.

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