For Doc Illogical....
JAMA you say? Take off the blinders and expand your paradigms
"External Control Arms and Data Analysis Methods in Nonrandomized Trial of Patients With Glioblastoma
Mandel, et al JAMA Oncol. Sept. 2023
- we are not aware of independent validations of these analytic methods in a GBM trial context outside of this present study, and therefore results need to be interpreted with caution.
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Gatto L, et al. DCVax-L Vaccination in Patients with Glioblastoma: Real Promise or Negative Trial? The Debate Is Open.
Cancers 2023 Jun 20
"When considering PFS data, the study is negative, and the trial did not reach its prospectively defined primary endpoint. Therefore, from a purely formal point of view, the study should be declared negative.
- The comparison of the investigational arm with an external control group should be considered a post-hoc retrospective analysis, suitable for generating hypotheses but not providing high-quality evidence.
Non-randomized externally controlled studies are gradually becoming attractive because they are faster, cheaper, and limit the number of patients exposed to substandard or ineffective interventions, but they are inadequate for a phase III trial and require a pre-specified detailed protocol and robust statistical methods to minimize the risk of bias. In this trial, the comparison of the active treatment arm with the external control population was not based on individual datasets from the selected randomized clinical trials; however, an indirect analysis was performed at the trial level with survival data reconstructed by an algorithm. This trial does not provide a comparison on patient-level data, which compromises the quality of the evidence and the the reliability of the results."
