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Saturday, February 20, 2021
Issue 5806

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

  • Phase I trial of intranasal NEO100, highly purified perillyl alcohol, in adult patients with recurrent glioblastoma         Although the results were only good but not remarkable, it is a simple and well tolerated. Perhaps it could be added to other treatments as part of a cocktail approach.

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