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
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