From Insight to Impact: Making Non-Clinical Claims Work Harder in Pharma Marketing

In pharmaceutical marketing, we’ve long known the power of a good claim. Efficacy data. Safety outcomes. Statistical significance. But increasingly, the most compelling claims aren’t coming from the clinical section of the label, they’re coming from how a brand makes people feel, how it fits into their lives, and how it solves real-world problems.

Sitting at the intersection of research, brand strategy, and real-world impact are non-clinical claims. When done right, they can be just as impactful as their clinical counterparts.

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What Are Non-Clinical Claims?

Non-clinical claims are statements about a product’s emotional, experiential, behavioral, or operational value, without relying on traditional clinical endpoints like overall survival, progression-free survival, or adverse event rates.

They can be patient-centered (e.g., “Designed with mobility in mind”), provider-centered (e.g., “Streamlines infusion workflow”), or even system-centered (e.g., “Reduces burden on nursing staff”).

These claims don’t necessarily prove the drug works better. Instead, they help position it more effectively in the real world.

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Why They Matter More Than Ever

As markets become more crowded and treatment options more clinically comparable, non-clinical claims become a key battleground for differentiation.

They create space for:

• Telling a richer brand story beyond the data
• Tapping into emotional motivators like hope, control, or trust
• Resonating across multiple stakeholders, not just physicians, but patients, caregivers, and practice staff

They’re also often more flexible than clinical claims when it comes to creative deployment across digital, social, and DTC channels, where attention spans are short and emotional resonance matters.

But here’s the catch, just because a claim isn’t about clinical outcomes doesn’t mean it’s easier to use.

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The Regulatory Reality: Rigor Still Applies

The FDA still considers non-clinical promotional claims subject to a high standard: they must be truthful, non-misleading, and substantiated.

That means vague assertions, hand-picked anecdotes, or fluffy creative headlines are not enough. The claim must be:

• Rooted in evidence (often generated through primary market research)
• Statistically sound and methodologically rigorous
• Interpretable in context by the intended audience

Just as you wouldn’t bring a new efficacy claim to legal without clinical data, you shouldn’t bring a non-clinical claim forward without credible research behind it.

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A Research-Led Approach to Claim Development

This is where many teams go wrong. They generate claims in silos, creative writes the language, insights rubber-stamp it, and legal gets brought in only to strip it down.

Instead, the process should look more like this:

1. Start with insight. What emotional or functional needs are unmet? What language do patients and HCPs naturally use?
2. Explore through qualitative research. One-on-one interviews help uncover claim territories, emotional tensions, and product perceptions that can be refined into candidate statements.
3. Validate through quantitative research. Use structured testing to understand which claims are believable, motivating, differentiated, and which aren’t.
4. Pressure test with regulatory. Align with medical and legal early on in the process. Show your research approach. Evidence everything. Demonstrate how each claim is grounded in feedback, not assumption.

Done well, this approach doesn't just lead to better claims, it leads to stronger cross-functional alignment and faster approvals downstream.

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Common Pitfalls to Avoid

The biggest breakdowns in developing non-clinical claims tend to fall into a few predictable categories:

• Claims that are too vague. Phrases like “easy to use” or “patient-friendly” are meaningless without specificity or evidence.
• Claims that overreach. Words like “transformative,” “unparalleled,” or “revolutionary” are red flags without data to back them up.
• Claims built without a research plan. Relying on instinct or anecdotal feedback without structured, replicable research can sink a campaign in MLR review.
• Misalignment between teams. If insights, brand, and regulatory aren’t involved from the start, the result is often rework, or worse, wasting precious financial resources and time on unusable claims.

Avoiding these pitfalls means slowing down early so you can move faster, and with more certainty, later.

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What Good Looks Like

The strongest non-clinical claims are not just “nice to have.” They are:

· Strategically aligned with your brand’s positioning

· Emotionally compelling to your customer

· Backed by real evidence, with the research plan to prove it

· Clear and specific enough to stand up to regulatory scrutiny

· Flexible enough to live across personal and non-personal promotion

In a world where customers expect more from pharma, more relevance, more humanity, more understanding, non-clinical claims are a powerful way to close the gap between clinical promise and lived experience.

Whether you’re preparing for launch, refreshing your positioning, or crafting a new campaign, don’t overlook the potential of non-clinical claims. When built on a foundation of insight and rigor, they can be the connective tissue that brings your brand to life and brings your customers closer.