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In the present study, morphology was diagnosed prospectively using a central review system.
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If <2/20 patients achieved a response (PR or CR per RECIST 1.1) using a central independent radiology review in Stage 1, then the treatment would be deemed futile and no additional patients would be enrolled into Stage 2 for that treatment schedule.
An Institutional Review Board approved the protocol for each site; 9 sites used a central ethical review board (Quorum Review, Seattle, WA), while the rest used their local Institutional Review Board and all enrolled patients provided informed consent.
It also provides reliable transfer of images to a central review site.
A central review by an expert in sarcoma pathology should be made for equivocal cases.
A central review of cardiovascular toxicity was performed by an assigned cardiologist.
The Biomedical Research Centre BRC Oxford Molecular Diagnostic Centrere (MDC) will provide a central review of histopathology diagnostic samples during the study.
The other studies did not specifically state that a central review was performed.
We compared information from patient history by a retrospective review of notes and used a central database of child immunisation records as the reference standard.
SAFE [ 6] used a central minimization algorithm.
Trials using central review of imaging should consider using CTP for handling image data when a multisite trial is being designed.
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