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seekinganswers

09/09/25 1:27 PM

#787316 RE: QL300 #787315

What about the many OTHER peer reviewed papers that poo poo'd the trial, that didn't have massive conflicts of interest?
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AllSheWrote

09/09/25 1:34 PM

#787317 RE: QL300 #787315

Those doctors have nothing to do with MHRA's standards.
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exwannabe

09/09/25 1:43 PM

#787323 RE: QL300 #787315

According to who exactly? Wasn't that signed off on by more than 70 doctors?


You mean the 70 trial inevstigators who noted:

Limitations
This study has limitations. Since individual patient-level data for the ECPs were not available for this trial, as is often the case, propensity score matching could not be performed, which is a potential limitation of this study. However, the MAIC analysis applied here is a powerful method to overcome the lack of such individual patient data and to enable matching of specific patient characteristics in external controls compared with patients in the investigational group. This method also has wider general applicability to provide reliable comparative evidence of benefit.18



You might note that EVERY guidance being issued by an RA that has been cheered by this message board asserts individual patient level data is needed for pivotal data and summary data does not cut it. And everybody knows that MAIC stuff is a poor substitute for patient level data.

Sure, I will agree the 70 who signed paper that the trial was fine for what is properly called "hypothesis generating". Now they just need to run a proper trial to prove.