Brief · Use case · Brand & Marketing
Comparative Claim Assessment.
LiveAssessmentJudge whether the head-to-head evidence supports a comparative superiority claim, how strong each support is and what would make the claim fail review.
Comparative Claim Assessment is a ready-made use case for Brand & Marketing. It ships under the Assessment template.
For brand and compliance leads reviewing a claim before use. You get a position with its confidence, the evidence graded finding by finding, the strongest objection answered and what would overturn the position. This is analysis for review, not legal advice, and claims are cited or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
How well supported is the position that the available head-to-head evidence substantiates a comparative superiority claim in promotional materials for a prescription medicine?
What the assessment examines
A comparative claim must be consistent with the product information and capable of substantiation. The assessment checks the claim against the rules and the evidence against the claim.
| Part of the position | What the assessment examines | Where it looks |
|---|---|---|
| Consistency with the product information | EU law requires every part of advertising to be consistent with the summary of product characteristics and to present the product objectively without overstating its properties.1 | Directive 2001/83/EC, Article 87. |
| The standard for claims | Promotion must be accurate, balanced, fair, objective and sufficiently complete, based on an up-to-date evaluation of all relevant evidence, and capable of substantiation on request.2 | The EFPIA Code of Practice, Article 3. |
| Comparisons and superlatives | A comparison is allowed only if it is not misleading and compares material, relevant, substantiable and representative features. A superlative is allowed only for a clear, demonstrable fact.3 | The ABPI Code of Practice 2024, Clause 14, as one national example. |
| What the head-to-head design can show | Whether the comparator, population and endpoint support superiority and not only non-inferiority, and what the choice of control group allows one to infer.4 | ICH E10 on the choice of control group. |
What the assessment does
Superiority has to be shown, not implied. A head-to-head trial designed to show non-inferiority cannot by itself support a claim of superiority. The assessment checks the trial’s design and hierarchy of endpoints against the wording of the claim.4
The claim and the label. Under EU law, advertising must be consistent with the summary of product characteristics. The assessment checks whether the claim, and the population it applies to, sit inside the approved information.1
The code’s own words. The EFPIA Code asks for promotion that is accurate, balanced, fair and objective and based on an up-to-date evaluation of all relevant evidence. The ABPI Code adds that a superlative must be a clear, demonstrable fact. The assessment quotes the clause it relies on and says which national code applies.2,3
The strongest objection. The objection is usually that the claim selects one endpoint or one population from a trial that did not favor the product overall. The assessment restates it fairly and answers it from the full evidence.
Recommended length
Comprehensive
The position will be challenged by people who hold another view. Comprehensive adds the alternatives considered and the reasoning behind the support, which is what a challenger asks for.
You can pick another length on the form. The other two stay available.
Assumptions the assessment checks
The assessment states the assumptions the position rests on and says which one would hurt most if it failed. Examples for this position:
- The head-to-head trial was designed and powered for the comparison the claim makes.
- The claim is for the population and the dose in the approved product information.
- The evidence cited is the complete body of relevant evidence, not a selection.
Standards, guidance and sources
EU law and codes
Trial design
- ICH E10, choice of control group in clinical trials.4
The decision practice behind the memo itself is on the template page.
What gets flagged
Any endpoint or population the claim picks out that the trial did not name as primary, any claim wider than the approved information, and any superlative that is not a clear, demonstrable fact.
What arrives
- The position
- The basis
- Why the evidence supports it
- The strongest objection, answered
- Other views considered
- Where it is weak
What it will not do
It does not recommend an action. A Decision Memo takes the assessment as its starting point.
It is not an approval of the claim. The claim still goes through your medical, legal and regulatory review, and the code of your market applies.
It does not recommend an action. An assessment says how well a position is supported; a Decision Memo recommends what to do.
Certainty ratings are analyst judgment from an AI specialist, not measurements, and the reason for each is on the page so you can disagree with it.
It does not settle a question the evidence leaves open. Where the evidence is thin, the assessment says so and says what would settle it.
References
- [1] European Parliament and Council. Directive 2001/83/EC on the Community code relating to medicinal products for human use. Consolidated version of 1 January 2022, Title VIII (advertising), Article 87. Article 87(2) and (3) read on 9 October 2026. Check the current consolidated version.
- [2] EFPIA. EFPIA Code of Practice, 2026 edition, Article 3 (promotion and its substantiation). Sections 3.01 to 3.03 read on 9 October 2026.
- [3] Prescription Medicines Code of Practice Authority. ABPI Code of Practice 2024, Clause 14: Information, claims and comparisons. A United Kingdom example; check which national code applies in your market.
- [4] European Medicines Agency. ICH E10: Choice of control group in clinical trials (Step 5), CPMP/ICH/364/96. Date of effect 1 January 2001.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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