PAAB is proposing to expand the types of evidence eligible for supporting advertising claims related to healthcare products.
Currently, the PAAB Code of Advertising Acceptance (Code) requires that clinical or therapeutic claims in the advertising and promotion of health care products be limited to claims based on published, peer-reviewed, controlled and well-designed clinical studies of specific patient populations, such as randomized controlled clinical trials (RCTs).[1] To a lesser extent, high quality meta-analysis and observational studies may sometimes be acceptable. [2]
PAAB is now proposing to amend the Code to permit advertising claims based on an expanded definition of clinical data, to include data that is not derived from RCTs.
PAAB has recognized that data on the performance of healthcare products is now generated in a variety of settings outside RCTs, including, Real World Data (RWD). PAAB has therefore set out the categories of evidence derived from RWD, so-called real-world evidence (RWE) that can be used, the types of advertising health claims that can be supported by RWE, and the quality criteria that RWE must meet.[3]
PAAB Admissible Real World Evidence (RWE)
Not all RWD, or evidence derived from RWD will be eligible to support health claims. Recognizing the heterogeneity of real world data and evidence, PAAB has categorized eligible evidence derived from RWD that can be used in support of marketing claims into the following four categories:
- Observational studies;
- Explanatory trials;
- Pragmatic trials; and
- Market dynamic data.
Briefly PAAB has proposed to define each of these categories of data as follows:[4]
Observational studies include cohort studies, case control studies, and their variants, where cohort studies follow groups of participants either forwards or backwards in time to measure association between exposure and response, while case control studies organize patients into cases based on an experienced outcome.
Explanatory trials are a type of RCT designed with features to control for most, if not all, sources of bias and test whether an intervention works under optimal situations.
Pragmatic trials are those that evaluate the effectiveness of interventions in real-life routine practice conditions.
Market dynamic data can be used in support of claims such as those relating to retention/persistence, therapy sequencing and switching where it is provided by recognized entities independent of the pharmaceutical company.
PAAB proposed uses of RWE
PAAB is proposing the following three uses of RWE in support of advertising claims that:[5]
- Corroborate existing therapeutic and safety claims
- Support therapeutic and safety claims in separate populations
- Relate to new measures such as adherence, market dynamics, and disease epidemiology
PAAB proposed criteria for high quality RWE
PAAB is further proposing that not all RWE falling into its proposed categories will be eligible for use in support of advertising claims. Instead, it is proposing to limit admissible RWE to RWE that meets PAAB defined criteria for transparency, relevance, validity, and reliability.[6]
It should also be recalled that, whether using RCT or RWE, all drug advertising messages must be consistent with the product's terms of marketing authorization. As a result, although the proposed change to allow the use of RWE may broaden the scope of reliable evidence that can be used to support claims, it will not change the core principles of the Code. Any advertising outside of the limitations of the Health Canada accepted terms of marketing authorization will remain off-label and may lead to severe sanctions.
RWE is more likely to expose manufacturers to off-label issues. Thus, manufacturers should carefully assess the objectives and parameters of their RWD collection and analysis, starting with the very design of their RWD reviews and studies. RWE that is aligned with the Code and the proposed PAAB guidance may reduce risk exposure in light of Canadian drug advertising rules and will be all the more valuable.
Before implementing changes to the Code, PAAB is seeking comments up until January 31, 2019.[7]
[1] PAAB Code of Advertising Acceptance, section 3.1.1
[2] PAAB, Guidance Document for Claims based on Non-Experimental (Observational) Studies, January 2013.
[3] See proposed changes to the PAAB Code of Advertising Acceptance, sections 3.1.1, 3.1.11, 5.7, and 11 for proposed definitions of real-world data, real-world evidence and use in marketing claims
[4] See proposed definition of High Quality "RWE" in The Use of Real World Evidence in Advertising Promotional Systems (APSs): A PAAB Guidance Document
[5] See proposed uses of RWE in The Use of Real World Evidence in Advertising Promotional Systems (APSs): A PAAB Guidance Document
[6] See proposed criteria defining High Quality RWE in The Use of Real World Evidence in Advertising Promotional Systems (APSs): A PAAB Guidance Document
