PASSReviewer 1· 85% conf
The study design is a post hoc analysis of a randomized trial, with clear inclusion/exclusion criteria and appropriate statistical methods, though it is not a new interventional design.
Evidence
direct quote[Methods, ADAURA trial design]
“Full details of the phase 3, double-blind, placebo-controlled ADAURA trial have been reported previously”direct quote[Results, Patient characteristics]
“Of 682 patients randomized in ADAURA, 239 (35%) had available matched tumor, germline DNA and plasma samples for development and testing of tumor-specific RaDaR panels at the time of data cut-off (DCO)”direct quote[Methods, Statistical analysis]
“This analysis of MRD is a post hoc exploratory analysis separate from the prespecified primary and secondary endpoints of the ADAURA study.”PASSReviewer 2· 95% conf
The study design is rigorous, leveraging a randomized, double-blind, placebo-controlled trial with clear inclusion/exclusion criteria and a pre-specified analysis plan for the primary endpoints, though the MRD analysis is post hoc.
Evidence
paraphrase[Methods, ADAURA trial design]
“Patients were stratified per disease stage (IB, II or IIIA), EGFR mutation type (Ex19del or L858R) and race (Asian or non-Asian), and then randomized 1:1 to receive osimertinib (80 mg QD) or placebo.”paraphrase[Methods, ADAURA trial design]
“Full details of the phase 3, double-blind, placebo-controlled ADAURA trial have been reported previously.”paraphrase[Methods, Statistical analysis]
“No statistical methods were used to predetermine sample sizes but our sample sizes are larger than those in refs. 24,25,26 or similar to those in ref. 27 as reported in relevant previous studies.”