All data presented in Advertising/Promotion Systems (APS) including: charts, graphs, tables or other reproductions extracted from reference studies or other sources or reproduced by artwork, must be accurate, complete and clear. The source(s) must be identified. Each adaptation of data should be so labelled and the source(s) indicated.
In charts, graphs, tables and other reproductions extracted from the reference studies; the advertiser must not introduce data or imply conclusions that do not appear in the references.
An advertisement should include all pertinent titles, legends and other designations appearing in the reference.
Adaptations of data must be presented in a manner that does not add or subtract from conclusions of the author(s) unless required under a separate provision of the Code.
Statistics must be presented so as to accurately report the findings and to help make reliable and valid conclusions.
Statistical information should include dosage and the level of significance (e.g. confidence interval [CI] and/or p-value), in the presentation. Where confidence intervals and p-values are both available, the manufacturer may decide to report both. The use of 95% CI is encouraged in preference to p-value. Information such as patient numbers, time span, dosage, etc. that are needed to assess the data, may appear in the web link destination containing the Terms of Market Authorization (TMA).
The advertiser must honor market research company agreements and must submit a release of market share claims from the source of the data. Data should be the most current available, at least within the past six months.
Reporting clinical trial results in relative or proportional terms may lead to misinterpretation of the true benefit and degree of a treatment effect. APS which present results using these methods of reporting, namely relative risk (RR) or relative risk reduction (RRR), must also include an indication of the absolute treatment effect. This can be presented as absolute risk reduction (ARR), number needed to treat (NNT) and/or the actual comparative clinical results or rates. The overall presentation should reflect the true magnitude of benefit and not magnify the clinical effect. Undue emphasis on treatment effects in relative terms, by means of graphic presentation or differences in type size, is not acceptable.
Data presentations which are misleading or ambiguous, or which distort the original meaning or interpretation, either directly or by implication, are in violation of the Code.
Company-generated charts/graphs, etc. from pooled studies may not be acceptable.
Company-generated charts/graphs, etc. must not distort the conclusions of the author(s) by visual manipulation.
Reference lists and study parameters may be moved to a web link destination. Click here for examples.
A prominent statement within the main advertising message must identify that this content can be accessed at the web link destination. The linkage mechanism may be a URL (for example in a print tool) or an electronic link. The URL may be supplemented, but not replaced, by an electronic coding system (e.g. a QR code or a bar code).
The reference list and study parameters are assessed by PAAB during review of the corresponding APS. A separate review of the link destination webpage is not required where the contents of that page are limited to the following:
- Product logo (without tagline) and/or the corporate logo
- Reference list and/or study parameters
- TMA and risk communications
- An optional link to the post-gate homepage when the web link destination is part of a broader site
- Optional branding colour scheme without images
Web link destination pages having additional content (whether text or images) are required to be submitted for PAAB review as a separate APS.
Where mandated by the consumer advertising regulations, the web link destination must either be gated or de-indexed from search engines. If the site is gated, the URL or electronic link promoted in the APS must bypass the gate such that password entry is not required to access these disclosure documents. The URL and electronic link must therefore be promoted only to HCPs.
Reference citation format should be clear and complete. PAAB may require changes where there is an off label or misleading claim in the title.
When relegated to link destinations, the APS reference list and study parameters must take one of the following forms:
Different link destinations for each APS:
- Each link destination contains the reference list and study parameters specific to the corresponding APS
- The reference numbers and sequence in the link destination match those in the APS
- Within the preclearance process for the corresponding APS, the entire list of references and study parameters would undergo PAAB review
Single link destination common to each of this product’s APS:
- The link destination houses a master list of the references and study parameters used across this product’s advertising campaign
- The reference numbers on the destination webpage match those in the APS (although the sequence will likely differ)
- Within the PAAB preclearance process for the corresponding APS, those references and study parameters relating to the piece are reviewed
- The Market Authorization Holder must remove references and corresponding study parameters from the master list if acceptance of all APS utilizing those references expires
The content on the destination site must be in the same official language as the APS.
The Market Authorization Holder is required to ensure that the link and the destination are maintained for the duration of the period for which traffic is sent to that link/destination or for the period of use of the “originating piece”.