488 - What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've searched the PAAB website and haven't found this addressed anywhere. Many thanks in advance for any guidance.)
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It’s difficult to predict all the info needed to guide you in the right direction as I don’t know exactly what you have in mind; however, here are the themes that jump to mind as likely being relevant to your case. Ultimately the evidence requirements are dependent on the types of messages which need to be supported. “Appropriate courses of therapy” (e.g. what should we do now?) should reflect authoritative Canadian consensus guidelines (per s3.2) rather than relying on faculty opinion/recommendations. The courses of therapy should also be consistent with the relevant product monographs (s3.1). It sounds like you’ll need to be careful to avoid creating a piece which disparages the sponsor’s competitors (s5.6.iv). Finally, as the piece is intended to be “unbranded” you’ll want to make sure you adhere to the principles in s7.5 for editorial advertising. For example, make sure the piece NEITHER emphasizes the sponsor’s product over the others NOR favours it over the others. You might want to consider submitting an opinion file with a detailed description of the concept prior to testing (see the fee schedule on the website).
