Inquiry on observational study material
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We are looking into developing a one pager that contains information on a observational study that is being conducted, and it will be provided to patients that have been prescribed the product by an HCP. This piece will not be promotional in content and is mainly intended to provide the patient with information on the type of study, its purpose and what the patient's involvement in the study, should they choose to participate, will look like. Would a material like this be subject to PAAB preclearance?
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We are looking into developing a one pager that contains information on a observational study that is being conducted, and it will be provided to patients that have been prescribed the product by an HCP. This piece will not be promotional in content and is mainly intended to provide the patient with information on the type of study, its purpose and what the patient's involvement in the study, should they choose to participate, will look like. Would a material like this be subject to PAAB preclearance?
Hey @nimisha
The Distinction Between Advertising and Other Activities speaks to criteria for clinical trial recruitment and when it can be considered to be exempt from advertising regulations. Note that bullet 4 reads “in the case of patient recruitment, no reference is made to the drug manufacturer's name, or to the name of the drug under investigation”. Therefore, it is not possible to meet the requirements in the context of a branded piece.
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Hey @nimisha
The Distinction Between Advertising and Other Activities speaks to criteria for clinical trial recruitment and when it can be considered to be exempt from advertising regulations. Note that bullet 4 reads “in the case of patient recruitment, no reference is made to the drug manufacturer's name, or to the name of the drug under investigation”. Therefore, it is not possible to meet the requirements in the context of a branded piece.
@jennifer-carroll Hi Jennifer, thank you for your response. If the material meets the criteria in the Distinction Document, can you confirm that the HCP prescriber can provide the one pager to patients that have already been prescribed the drug? Would it exempt from PAAB pre-clearance if this is the case?
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@jennifer-carroll Hi Jennifer, thank you for your response. If the material meets the criteria in the Distinction Document, can you confirm that the HCP prescriber can provide the one pager to patients that have already been prescribed the drug? Would it exempt from PAAB pre-clearance if this is the case?
Hey @nimisha
Unfortunately, we cannot provide this confirmation as it does not appear that the project will meet the criteria outlined in the Distinction Document (it will inherently be branded). We suggest submitting for an opinion to receive more specific feedback in this specific case.
