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Hey @demerssy
Based on the information provided, the study may be acceptable. However, we will need to review the specifics of the claims and the study prior to final comment. The PAAB offers an opinion review if you would like to obtain a detailed assessment of the study and proposed claims prior to developing APSs based on the study.
Happy Friday @Manufacturer and @Agency
Based on input from various stakeholders, PAAB has drafted a guidance on disease burden to expand the range of information that may be acceptable for presentations of disease information in advertising. This draft is now in circulation for consultation until April 24th. If you would like more information, please reach out to Pauline Dong.
Leave questions below or click here to access the link:
Hey @palanski
Great question. PAAB’s strategic plan for 2023-2025 includes a focus on increasing the extent to which HCPs value health product advertising and industry-generated patient information. This is the primary motivation for the shift outlined in the disease burden document. This shift is one element of a multi-pronged approach towards that aim. The standards outlined in the document were generated in consideration of our global benchmarking and stakeholder consultation activities.
While health product manufacturers’ have expressed a long-standing desire to provide more detailed presentations of disease states, it took some time to establish a set of standards that effectively aligned that desire with the interests of patients and HCPs. The objective of PAAB is to ensure that disease information (including burden of disease) does not suggest use and efficacy for outcomes which the brand has not been demonstrated to address. This objective remains however PAAB has looked to explore ways that we can meet this objective while allowing more latitude on disease presentations.
In short, the document seeks to outline principles that will mitigate the risk that the disease burdens be interpreted as outcomes that the drug can improve. The document also reiterates the requirement that the disease information and descriptions of disease burden must pertain to the promoted product’s indication.
Our hope is that manufactures will view the guidance document as a collaborative means to providing greater flexibility in relation to disease information presentations in HCP advertising, disease information presentations in patient information, and disease burdens conveyed in creative imagery.
It’s Friday @Agency @Manufacturer and PAAB wants to send you into the weekend with some exciting news: The NEW Creative Imagery in Advertising Advisory is NOW live!
After months of insightful and collaborative discussions, we’re excited to finally announce PAAB’s new advisory on the use of creative imagery in pharmaceutical advertising. Industry has asked for clarity, and we hope this document provides that clarity you’ve been waiting for, or at the very least, provides a stronger framework to evaluate creative ideas with your teams.
Note that this is not the finish line. This is a starting point to continue to grow and evolve with the ever-changing landscape, to meet the needs of healthcare professionals and patients.
We’d like to extend our gratitude to all the industry members of the Creative Committee who took time to share challenges, discuss the advertising landscape, listen to the regulatory concerns and work collaboratively with PAAB to refine the creative imagery discussion.
Special thanks to Mike Spelay (bMod), Andy Leeson (Wellworth and Best), and Konstantine Polanski (Point05 Health), for driving the revisions from the first draft document and creating meaningful examples. Thank you to the bMod team for generating creatives to help capture the principles outlined throughout the document.
We look forward to implementing these new approaches with you and continuing the conversations.
Happy Wednesday @Agency and @Manufacturer
PAAB has made changes to formulary review practices.
NEW
When a product used as indicated would be covered, the sponsor can include the formulary coverage even if the criteria is broader than the indication (e.g., the indication is for moderate to severe condition X and the criteria is for condition X), provided that the indication is presented prominently directly before the criteria to establish the context. The indication should reflect the same condition as the criteria and, at a bare minimum, the font size should be 75% of the size of the criteria. This is similar to treatment guidance used for fair balance.Note: This applies even if the indication is already included elsewhere in the APS.
There should also be NO undue emphasis on the broader condition or criteria, (e.g., bolding, callout, headline, etc.,) such that it appears as off-label promotion.
Reminder: When applying the above provisions, overt off-label criteria continue not to be acceptable in drug advertising per code section 3.1.
See our revised formulary advisory page which combines all three formulary resources into one location.
@COREkarentaylor, yes, there are circumstances where an unadjusted p-value can be used to support a claim in an APS directed at HCPs. In fact, even when adjustments would have been required to mitigate familywise type 1 error rate, a claim-neutral presentation of the data may be acceptable. Here are some of the key points you’d want to keep in mind.
When the study and secondary endpoint do not (in and of themselves) contravene the code, data may be presented in a factual unembellished manner. When there is no adjustment for multiplicity, the claim should appear neutral. Simply present data with corresponding stats (text or graphic form) without the addition of elements to the data presentation which suggest an improvement or difference (e.g. relative reduction callouts/arrows, NNT). Claim neutrality also applies to context (e.g. headlines & tabs). Introduce the data presentations with “topics” (e.g. “efficacy” as opposed to conclusions (e.g. demonstrated powerful efficacy). The presentation must state that the presented CI or p-value is unadjusted. For example, it suffices to insert “(unadjusted)” next to the CI or p-value. Note that p-values & CI cannot be relegated to weblink destinations. Essentially, provided statistical analysis is presented to satisfy s5.9, we’ll allow a data presentation. But we’ll reject overt and contextually implied claims of efficacy/safety/difference.
For subgroups, in addition to the above, one must present the subgroup of interest along with all of the complementary subgroups with equal emphasis (such that none stands out). E.g. Can’t just present male data, must present both male and female data3.
Note that this response assumes the primary endpoint was statistically significant. Secondary endpoints cannot be used to salvage a failed study.
Good Morning @Agency and @Manufacturer
To show our appreciation to your dedication to staying informed and up to date on all things PAAB by registering for the PAAB Forum, we wanted to share the new PAAB logo with you FIRST!
So without any further wait, here it is:
Let us take you through a summary of the significance of each aspect of the design elements.
Background colour: From both a design and versatility perspective, it was decided that the background colours should remain white. This makes the logo clear and consistent across pieces regardless of the surface of the ad to help HCP’s and patients efficiently identify credible information about health care products.
Maple Leaf: In recognition that PAAB is a Canadian company working in the best interest for the health and safety of Canadians, it was deemed pertinent to keep the maple leaf to easily identify PAAB as Canadian. The rationale for the maple leaf above the checkmark allows for ONE iconic representation for the PAAB instead of 2 separate icons.
Checkmark: To improve on the logo, the checkmark was added to visually signify that the piece had met a standard for acceptability. This in combination with the PAAB acronym ties the preclearance of the piece back to the PAAB code and organization. Green colouring was added to help further elicit the feeling that the content is trustworthy and supports health and safety.
Words: To pull the logo together and more clearly convey the independent review service that PAAB provides, the copy “Reviewed by” has been added.
What should it mean to me to have the PAAB logo affixed to promotional information we have produced?
It indicates that this information is truthful and trustworthy as it has been independently reviewed to meet high standards.
Why should this matter to me?
High quality information is at the core of state-of-the-art patient care.
Why is the PAAB logo changing?
Easier identification of promotional information that has been independently reviewed to support health and safety of Canadians.
The PAAB is grateful to all the participants of the Logo Committee for their contributions in creating this new logo and to cdm Montreal for the new logo. If you’d like to read more about the Logo Committee and the work they did to develop the new logo, please read more about it here. Over the upcoming days we will be sharing more information about this initiative across all our communication channels.
Happy Spring @Manufacturer and @Agency 
The first quarter of 2023 has been a big one. We've launched consultation on two draft guidance documents, posted additional guidance on gating, and an advisory on formulary claims, launched the Customer Experience Index (CEI) and more. See the PAAB Forum Quarterly Review to get caught up on all the action in Q1.
Please be advised
PAAB modified business hours for 2023 will start on Monday May 1st and end on Friday October 6th.
PAAB summer business operating hours will be:
Monday to Thursday 8:30 - 5:30pm
Friday 8:30 - 1:15pm
Please note: eFiles modified hours submission end times will be:
Monday - Thursday 4:30pm
Friday 12:15pm
On behalf of the PAAB staff, have a safe and happy spring season.
HI @keoca
This would be considered a service-oriented vehicle and would be subject to review as it is part of the HCP-patient interaction in the context of the brand. It could likely be submitted as one file.
Good Morning @alee
What a great question. This one got us thinking. 
We see your point if the sponsor can confirm that the cookies are tied strictly to cellular phones, this would appear to be sufficiently targeted to HCPs. Tablets, ipads, and other such devices are much less likely to be tied in a 1:1 ratio with the user (HCP). There should also be explicit cookie approval by the HCP after they have been validated as an HCP. During the review, ALL targeting information would have to be provided. The standard practices for targeting should still be applied.
Thanks @palanski . We have plans to roll all the information required out to you over the coming weeks, but since you asked, we won't start using this logo until October 1st.
Hello @natbourre
Good Morning @palanski
There is not a part of the Code that states that it’s “not required”. Per the above response “. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece.” Code section 6 (Patient Information) states “Company controlled or prepared branded patient information is information that contains non-promotional material that is consistent with, and in addition to, the Health Canada approved patient information (e.g. the consumer information section of the product monograph, patient insert, approved product labelling)” and “All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims”. While other sources may support disease understanding, they do not act as sources of evidence for promotional claims which is the case in HCP advertising and therefore requires the source of evidence to be provided to the HCP for transparency. PAAB does not discourage inclusion of reference lists within patient pieces, it is simply not a requirement of the Code.
Happy Friday @manufacturer and @agency
PAAB is excited to announce that as of December 1st, we will be piloting an expanded approach to pre-NOC review practices that will allow for more pieces to be submitted pre-NOC and prior to the final draft stage of the PM.
Learn more here and share your comments and thoughts below. If you have any questions, please post them to the forum post at the base of the above PAAB page, or follow this link.
Thank you and have a great weekend.
PAAB Team
@Agency and @Manufacturer
We invite you to participate in our annual client survey, where your feedback will directly inform our future improvements.
About the survey:
• This quick, 10-minute survey is for everyone who works with PAAB, whether directly or indirectly.
• Your responses are entirely anonymous, all insights will be presented in aggregate via our research partner, CreateHealth.io.
To thank you for your input, you’ll receive a digital $10 CAD gift card (Visa and select store cards) upon completion.
Please note, to receive the $10 honoraria, you must provide your work email at the end of the survey, and it must be associated with your forum registration, eFiles records, or PAAB email list.
Share you views here today
Thank you in advance for your feedback!
PAAB
Is statistical significance required in the proposed future RWE guidance? If so, how can a single arm study can be presented?
We’ll start by building some context that supports the answer.
What is a single arm study?
A study type in which a sample of individuals with the medical condition are given the therapy and followed over time (either prospectively or retrospectively) to observe their response. This approach does not include a second sample of individuals to compare to.
Challenge of interpreting effectiveness from a single arm study
While this is a very simple trial design, the interpretation of effectiveness results is complicated by an inability to distinguish between a real treatment effect, a placebo effect, the natural course of the disease, or any combination of these. A robust interpretation of effectiveness generally involves a frame of reference for comparison.
Challenge mitigating the risk that apparent associations are due to chance alone
The preferred way to mitigate the risk that observed associations are due to chance alone is to perform statistical analysis on the difference or ratio between two groups that are very similar but that differ with regards to the independent variable. This sort of inter-group statistical analysis is not possible in a single arm study.
How does the above shape requirements pertaining to use of single arm studies in HCP advertising?
Single arm trials can be considered as the basis for data presentations pertaining to adherence/compliance, persistence/retention, safety and effectiveness. The explanatory statement (i.e., the statement next to the icon) must identify that this is a single arm study.
For such a study to be considered as the basis for presentations relating to safety and effectiveness, it must be published and peer-reviewed.
For effectiveness endpoints, the disclosure of key study limitations must also specify that the methodology may make it difficult to differentiate between:
drug effects and the natural history of the disease
drug effects and placebo effects
Please note that this requirement is in addition to the identification of the source as a single arm study in the explanatory statement.
Statistical analysis is not required in single arm studies. However, prominent disclosure of the sample size and a measure of dispersion in the outcome across the sample size is required.
For single arm studies, the PAAB will require that sample size and a measure of sample dispersion be presented within the body of the presentation (as opposed to among the study parameters). When a measure of sample dispersion is not available, the unavailability of this data must be included as a study limitation within the body.
This is intended to help HCPs evaluate how/whether they wish to use the study presentation in consideration of their view of:
the appropriateness of the sample size (n) in comparison to their understanding of the size of the corresponding patient population (N)
the degree of heterogeneity
We may consider allowing the use of the published, open-label study if they could prove to us that it was the basis of approval. To do this they would have to forward a copy of the S/NDS and any other pertinent correspondence from Health Canada. We could approach Health Canada on their behalf to resolve any contentious issues regarding the acceptability in advertising of their claims related to this study.
Hey @NatBourre
We have not received a response at this time. We will reach out to Health Canada to see what the status of this question is. In the interim, we will continue to apply our understanding that this cannot been done as this would contravene consumer regulations.
Hey @AnetteCPC
This would not be acceptable as the cookies would be placed on the computer, but they would not be able verify who is using that computer. If an HCP was to sign into a verified site on a shared computer, sign out and leave that computer, the next user would be exposed to advertising without verification that they are an HCP. This would contravene consumer regulations.
