RE: Silence10 Feb 2024 15:51
I’ll copy the source in the next post:
“ Conclusions
Classic 3+3 phase I trial designs have withstood the test of time. They offer rapid, but reasonable, dose escalation, with negligible rates of toxic death. Dose escalation based on toxicities (toxicity-adjusted dose escalation) seen rather than predetermined formulas may prove optimal. The data show that increased (rather than decreased) numbers of patients in phase I allow more precise determination of important side effects.13 Furthermore, expansion of cohorts in a phase I trial can even lead to regulatory approval after phase I in cases in which substantial activity is observed.2,3 Other considerations may include allowing intrapatient dose escalation, measuring concentration of drugs, and adjusting dosing for age, patient comorbidities, and drug levels. Bayesian designs in early phase oncology trials may also expedite knowledge acquisition.53 Trials evaluating immune checkpoint inhibitors also made extensive use of expanded phase I trials, enrolling hundreds of patients into dose-expansion cohorts following dose escalation, hence accelerating drug development.”