The Pharmaceutical Advertising Advisory Board (“PAAB”) has published a draft guidance document on the use of real-world evidence (“RWE”) in advertising directed to healthcare professionals (“HCPs”). The draft guidance document is available upon request from PAAB. PAAB is inviting industry stakeholders to provide feedback on the draft guidance document until the consultation period closes on April 3, 2023.
According to the draft guidance document, PAAB recognizes that not all clinical data that is relevant to clinical decisions by HCPs may be supportable by controlled and well-designed clinical trials with demonstrated statistical significance (so-called “gold standard” data). PAAB’s aim is to create a framework for use of RWE in advertising to facilitate delivery of the best data currently available to HCPs even in the absence of gold standard data, provided that the RWE data is sufficiently robust to be relevant and valuable to clinical practice.
Under PAAB’s proposed approach outlined in the draft guidance document, RWE may be used in advertising in addition to gold standard data, provided that the RWE data meets certain base requirements for validity and relevance and is presented in the advertisement in alignment with certain formatting principles, each of which is described below.
Base Requirements for Validity and Relevance of RWE
The draft guidance document provides the following nine criteria to be used to ascertain whether RWE meets basic requirements for validity and relevance:
- Consistency with the Product Monograph (i.e., study outcomes must pertain to the approved indication, and study population and treatment methodology must not be overtly inconsistent with the Product Monograph);
- Sourced from a published and peer-reviewed study;
- The study must contain sufficient methodologic information to enable identification of key study limitations and assessment of robustness of data;
- Study methodology is pre-defined and any amendments are justifiable. Data derived from data-mining activities are not acceptable;
- Data is collected from empirical observation (as opposed to modelling);
- Data from jurisdictions outside Canada is supported by a letter from the advertiser’s medical department outlining the data’s relevance to Canadian clinical practice;
- When the study includes comparators, the methodology must be equivalent for each group;
- Where data contradictory to the RWE data is known to exist, this fact should be disclosed in the advertisement in body copy; and
- Where the study has been reviewed by an authoritative Canadian body (e.g., CADTH, INESSS, Health Canada), this fact and the outcome of such review should be disclosed to PAAB by the advertiser.
Principles for Presentation of RWE in Advertising
The draft guidance document provides the following five principles for presentation of RWE data in advertising:
- Informational and claim-neutral presentation of RWE (e.g., RWE is not used as a basis for overt claims of benefit or creative imagery);
- The RWE data is boxed, is preceded by an icon and explanatory statement as to its source in body copy, and discloses key study limitations. The draft guidance document prescribes the icon to be used and the formatting of the box and required text in terms of size, font, colour, and position.
- Repetition of the RWE data requires repetition of the icon and statements described in (2) above.
- RWE presentation principles are not required to be followed for data that is exclusively based on content from the Product Monograph even if such data is not from controlled and well-designed clinical trials.
- An advertisement cannot be comprised solely of RWE data. Data from controlled and well-designed clinical trials must be included in the advertisement and must be presented prior to any RWE data.
The draft guidance document provides examples of the application of these principles to visual advertisements, as well as adaptations of these principles for advertisements in video or audio formats.
Our life sciences team has significant expertise advising the pharmaceutical industry on advertising compliance and other matters and is available to consult on the draft guidance document.