The Effective Statistician - in association with PSI cover image

Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance

The Effective Statistician - in association with PSI

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Isis Is a Ticklist for Collecting Adverse Events?

Draft guidance document touches on most of the things we'veut before, you know, being very clear. Evalidation that you study designs in isis isadequate for collecting whatever it is you've set out to achieve. Missing data handling still seems to be the biggest concern from regulatory perspectives. It doesn't seem as much a concern as it used to be, r in terms of of missing that information.

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