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600 - Regarding Code s3.1.1, does PAAB distinguish between different types of "pooled data"? For example a post-hoc pooled analyses of unrelated trials (low evidence), vs. a pre-specified pooled analyses of replicate trials (higher evidence)? Such pre-specified pooled analyses are commonly used in registration trials for certain therapeutic categories, and therefore interpretation of s3.1.1 could potentially be biased.
• Jennifer Carroll -
599 - Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled data are not regarded as high-level evidence, but in some cases Health Canada has requested the pooling of data, not the study design itself.
• Jennifer Carroll -
598 - Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).
• Jennifer Carroll -
597 - We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?
• Jennifer Carroll -
593 - We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the US guideline? If some of the products are not authorized in the same way in Canada as recommended in the guidelines, should we not mention that use or we should clarify that is not the way that is indicated in Canada? Thank you for your help.
• Jennifer Carroll -
590 - Hello, We plan to create a survey to gather statistics on lifestyle habits and general knowledge of the respondents on a virus in order to use the said metrics in a promotional tool, in the vaccination field. 1000 respondents is the usual number needed to produce relevant or serious statistics. The question is: As per PAAB's guidelines, is there a minimum number of respondents needed in a survey to be able to use the statistics produced by it in promotional tools. Thank you
• Jennifer Carroll -
585 - Hello - I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 data, is it acceptable to include year 3 data in APS? Would this be dependent on the year 3 data being directionally consistent with the year 2 data?
• Jennifer Carroll -
583 - A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.
• Jennifer Carroll -
582 - Can NBRx data be used to make market share claims, if the same principles governing TRx data were applied? Example: Arbace is the #1 dispensed hypertensive among new patients. If so, would the NBRx data need to be directionally consistent with the TRx data (ie. if Arbace is in fact not the #1 dispensed among ALL patients)?
• Jennifer Carroll -
575 - Our question is related to question no 70 which was: "The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]". PAAB answer: "The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims. Our question: Does PAAB regard "Guidelines" (such as CGA guidelines) as high and appropriate level of evidence for a side-by-side comparison of use limitations? Thanks
• Jennifer Carroll -
572 - As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X?
• Jennifer Carroll -
570 - Hi, We would like to highlight specific market data for our brand. We seem to fall into the guidelines that PAAB has put together but the specific data we would like to highlight is the new patient share (this consists of naive and switch patients). It would be a "leader" or "#1" claim. This data is from the private payer database (RxDynamics). Is this type of data allowable? I've done leader market claims as it relates to the total prescriptions dispensed but have never tried this type of data. Thank you.
• Jennifer Carroll -
567 - We would like to know if we can make a claim about the % of patients who would recommend a specific treatment to other patients. The % is published in a retrospective study done on patients who were taking this specific therapy. It is a patient reported outcome that is not in the Product Monograph. Please advise if there is any way to put such a claim through.
• Jennifer Carroll -
564 - Based on advisory board recommendations for supportive tools, a company would like to create an unbranded "reference tool" which documents the metabolic pathways for drugs in a particular therapeutic area. This would be a service item distributed by the representatives. Information would be taken primarily from Product monographs and in a few cases, the literature. Is there any reason this would not be allowed? what would be the constraints?
• Jennifer Carroll -
562 - Can we develop a sales aid where the user can select specific topics (efficacy, safety, cost) and then present these to a physician? The concept is to create a custom presentation based on the needs of the physician. So if a physician only wants to hear about efficacy and cost, those would be the only sections to appear. This would be like adding tabs to a print sales aid but since digital, we can create the sections that will appear based on the customers need
• Jennifer Carroll