Hi Jennifer - as a follow-up, would retargeting be more acceptable if limited to mobile users only? These devices are not shared, so we could more confidently ensure the ads are only served to the originally-validated HCP.
A
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Posts
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Retargeting and Digital Media (ads) -
Guidance on Patient Reported OutcomesHello - Based on the Guidance on Patient Reported Outcomes, are non-significant data presentations acceptable, if they are in a claim-neutral manner? In areas such as Oncology, treatments aim to have no worsening/deterioration in HRQoL vs. comparators. While this equates to a non-statistically significant difference, it is actually a positive clinical outcome.
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RWE Multivariate AnalysesHi Jennifer - Under the Guidance documents pertaining to KM Analyses (Provision 8 ) and/or Real World Evidence (s1.4), would PAAB accept retrospective studies that use multivariate analyses to identify prognostic factors associated with Overall Survival?
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Guidance Regarding Duration of Clinical Trials Used as Reference Support in AdvertisingHi Jennifer - as a follow-up to the March 2022 Q&A above, would data from a preplanned published extension study of a PM pivotal study be acceptable in the following circumstance: The Sponsor's product, drug A, has no restrictions on duration of use, it is used in combination with drug B, which is restricted to 1 year. The PM contains data at the end of year 1. The median follow-up of the extension study was 2 years. There were no amendments to the study design and it aligns with the PM in terms of the dosing, outcomes and patient population assessed. Understanding that the sponsor of drug B would not be able to leverage this data, would the sponsor of drug A be in a position to use the extension?
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223 - Hi, In the past we produced a branded APS presenting ongoing off-label trials. This piece was reviewed and approved by PAAB. Recently, we looked at the PAAB code and found that mentions of ongoing trials were acceptable in a non-promotional context. We have 2 questions: 1. Did the code change regarding the mention of ongoing trials? 2. Can you describe or give an example of a non-promotional context (unbranded material?)? Thank youOngoing Clinical Trials for investigational molecules
Hi Jennifer - As a follow-up to Q#223, can a branded APS contain a list of ongoing clinical trials for the approved product in combination with other investigational molecules? There would be no prominence on the unapproved products per s3.2.3, and disclaimers clarifying unapproved molecules/indications.
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Schedule C product advertisingDoes PAAB review HCP-directed advertising for Schedule C products (Radiopharmaceuticals)?
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pre-NOC editorial advertisingA sponsor has an existing Product-A indicated for Severe Condition-X. They will eventually have a new Product-B indicated for Mild Condition-X.
Question 1: Can they produce a pre-NOC editorial campaign discussing current treatment options for Mild Condition-X without alluding to future entrants?
Question 2: Could this be seen as off-label promotion of Product-A? -
PAAB-exempt name-only communicationsHi Jennifer - We have some questions regarding PAAB-exempt name-only communications.
- AskPAAB #137 on the original PMCQ site outlines that an HCP-directed exempt banner ad may link to the unedited PM. However the same question #137 on the PAAB Forum website has additional text, outlining that such a link would then render the banner ad no longer exempt. Can you provide clarification or advise which interpretation is correct?
- AskPAAB #330 and #517 both deal with a 'Coming soon message', but give conflicting responses on whether this message is considered exempt. Can you provide clarification or advise which interpretation is correct?