PASSReviewer 1· 85% conf
The trial design is rigorous: randomisation method and stratification stated, a priori power calculation given, open-label design with masked BIRC evaluation, and clear analysis populations defined.
Evidence
direct quote[Methods, 'Randomisation and masking']
“An independent statistician generated the 2:1 randomisation schedule using SAS software (version 9.4). A stratified block design was applied, with stratification by brain metastases (yes or no).”direct quote[Methods, 'Statistical analysis']
“With a planned enrolment of about 126 patients, the trial had at least 85% power to detect a 25% difference (docetaxel 10%; sac-TMT 35%) in objective response rate at a one sided α of 0.025.”direct quote[Methods, 'Randomisation and masking']
“The treatment assignment was not masked to investigators and participants, but the central evaluation by a blinded independent review committee (BIRC) was conducted in a masked manner.”PASSReviewer 2· 90% conf
Randomisation method, patient-level randomisation unit, open-label design with masked BIRC assessment, a priori power calculation, eligibility criteria, and the analysis populations are all clearly described.
Evidence
direct quote[Methods, Randomisation and masking]
“An independent statistician generated the 2:1 randomisation schedule using SAS software (version 9.4). A stratified block design was applied, with stratification by brain metastases (yes or no).”direct quote[Methods, Randomisation and masking]
“The treatment assignment was not masked to investigators and participants, but the central evaluation by a blinded independent review committee (BIRC) was conducted in a masked manner.”direct quote[Methods, Statistical analysis]
“With a planned enrolment of about 126 patients, the trial had at least 85% power to detect a 25% difference (docetaxel 10%; sac-TMT 35%) in objective response rate at a one sided α of 0.025.”