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Ready4bluesky

06/14/15 1:17 PM

#36436 RE: HappyLibrarian #36423

Any speculation about selection bias is simply speculation. And not all selection bias need be considered misconduct. One valid reason NWBO and the doctors involved would want to engage in selecting patients with a longer life expectancy is to ensure enough time for at least 4 injections and adequate time for the immune system to respond.

Whether or not the trial protocal for life expectancy changed during phase 1 is up for debate. It seems pretty clear it will be extended to > 6 months in phase 2. This change aligns with the hypothesis above that NWBO would want to be somewhat selective during enrollment. The extent of selection bias is unknown and there may have been a wide range of life expectancy in phase 1, but all were equal to or greater than 3 months.