394 - If a pharma company is developing a brochure that includes general information about clinical research to better educate patients who might be considering participation in a clinical trial, is PAAB (or another regulatory body) required to review and approve the brochure? Please note that this resource would not be developed for use during a specific trial; it is strictly for general patient education purposes.
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Patient information directed to patients through the physician would be reviewed under PAAB code s6. I am assuming that although the piece is general (i.e. not referring or alluding to a particular medication), information about clinical trials for drug therapy would be discussed (even if only on a concept level).
If you meant ‘general public’ rather than ‘patient’ then review from an advertising preclearance body would not be required. Nonetheless, you are free to use the PAAB consultative opinion service at your discretion (see www.paab.ca for fee schedule).
It sounds as though the piece is not intended to be a clinical trial recruitment piece. If it were, you’d also want to take a look at the section “Clinical Trial Recruitment” in the Health Canada policy document “The Distinction Between Advertising and Other Activities”.
