338 - Can you advise if published, qualitative studies are acceptable for patient preference claims under the new Code?

  • I presume you are asking whether it is acceptable to use a survey to assess patient preferences. If I am far off of your intended meaning give me a call.The code change had no impact on this topic. As per before the code change, we can consider this type of presentstion when the survey was conducted by a third party receiving unrestricted funding from the sponsor (e.g. sponsor had no influence on the design, the selection of participants, creation of the survey instrument, implementation of the survey, and the analysis of the results). Preference claims must be based on statistically significant results and limited to non-therapeutic aspects of treatment (e.g. "preferred the taste of... " or "preffered the nozzle length of..."). Open claims of "preferred drug X" (i.e. without explicit limitation to non-therapeutic aspects) are not accepted from surveys. Claims of "preferred the efficacy [or safety] of..." are also not accepted based on surveys. Again, call me of this is not what you were looking for.

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