just 12
"All 12 patients (100%; 95% confidence interval, 74 to 100) had a clinical complete response, with no evidence of tumor on magnetic resonance imaging, 18F-fluorodeoxyglucose–positron-emission tomography, endoscopic evaluation, digital rectal examination, or biopsy. "
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The plan is to enroll six patients with MSI, regardless of their primary cancer diagnosis. This cohort will serve to generate hypothesis and initial data to plan a larger study. All analyses from this cohort will be exploratory
> As with most experiments
This isn't true. It's absolutely standard in earlier trials of investigational agents to not have any sort of control arm.
> there's a control group (6 patients).
This isn't true. Within the study you posted, there are two different cohorts, with different patient types included.
> The control cohort may not have had cancer at all
This isn't true. The group you're calling a control cohort (cohort 2) must all absolutely have cancer, and are all actively treated with the study drug (TSR-042).
If comment OP was trying to misinform on purpose, it’s a different story as there’s no opportunity for improvement there.
>> As with most experiments
>This isn't true. It's absolutely standard in earlier trials of investigational agents to not have any sort of control arm.
Can we agree that Clinical trials are a small subset of all experiments? And that Phase 1 isn't as large?
For your second two points you're correct and I agree with you.
https://www.healio.com/news/hematology-oncology/20220605/dos...
> At the time of presentation, 18 patients were enrolled on trial.
> Results among the 14 patients with at least 6 months follow-up showed a complete response among all patients (95% CI, 74-100), with no evidence of tumor on biopsy, digital rectal exam, endoscopic visualization, fluorodeoxyglucose-PET or MRI. The other four patients are responding to treatment.