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learningcurve2020

07/14/24 4:34 PM

#706004 RE: dennisdave #706000

>>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. The lack of individual patient data analysis represents a limitation: this trial does not provide a comparison on patient-level data, which compromises the quality of the evidence and the reliability of the results.

Furthermore, the artificial generation of the external control group resulted in impressive differences in the control population from the vaccine arm. This is a further major methodological limitation: the validity of external controls was compromised by the demographic characteristics of the comparison studies. The studies selected as an external control group had different patient characteristics, and this represents an important confounding factor.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10296384/
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sentiment_stocks

07/14/24 4:45 PM

#706009 RE: dennisdave #706000

The data was not presented with truly patient level data as the clinicians were unable to access it. It would mean accessing the per person trial data from the Novocure trial used in the ECA, and there is likely no way that Novocure is going to hand that over to Northwest... ever. So they used other acceptable means to create as close to patient level data as possible, and that is the information I cited from the JAMA supplement provided in the P3 DCVax-L paper. I did not intend to confuse anyone, but rather buttress your case that while the data was not really patient level, it was more than made up for by all the various acceptable methods they used to present it.