Al's Comment:

 Patient reported outcomes should be a part of every clinical trial. Makes sense to have standards so they can be compared across trials and accepted by the FDA as endpoints for approving new drugs.  A good example of the need is a recent trial where the number of Glioblastoma patients working their normal job was way higher than expected, but the median survival did not change so the trial was deemed a failure.  The ability to be able to work at my normal job may be more important than just survival, especially if "surviving" means being bedridden.  Quality of life is of utmost importance and was never really taken seriously until recently because until recently nothing preserved quality of life for these patients.


Posted on: 02/19/2021

Setting international standards in analyzing patient-reported outcomes and QOL endpoints

 


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