Peer-reviewers have full time jobs, do reviews part-time and have a limited window to do a review. They are spoon fed a manuscript and selective back up form the Sponsor -- corresponding author Dr. Bosch. He chooses what to provide. Reviewers can ask for additional information but that doesn't appear to have happened. No added information attached to the publication other than Dr. Bosch's protocol/SAP versions. It is mostly what wasn't provided -- confounding, post hoc data dredged nature of the recurrent OS. Significant details about the external comparator trials.
JAMA Oncology is NOT JAMA.
From the JAMA Oncology article comments, a clear statement of the sample issues and how they bias the treatment arm:
"This is particularly problematic because the trial mandated exclusion of patients with significant residual disease, bilateral disease or early disease progression. In fact out of 1599 patients screened, 1268 were excluded for a range of reasons including disease progression and early clinical deterioration (Liau JTM 2018). While the matched cohort included some trials that excluded early progression, not all did, and since these were different trials, patients may have been excluded using different definitions of early progression from that used in this trial. In addition, there is evidence of general improvement in OS in patients with GBM enrolled in trials: for example, the median OS in the control studies for patients with MGMT methylated GBM receiving chemo-radiotherapy with Temozolomide is quoted as being 21.3 months; we note that the recent NOA-09 study had a median OS of 31 months in that same group of patients, emphasising the importance of using data from contemperaneous randomised controls. The general effect is these would be to increase the survival rate in the trial arm, irrespective of the effect of DCVax."
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