How to Claim Your Claim

Marketers Can Use Survey Research to Generate a Non-Clinical Promotional Claim that Moves the Needle

By Noah Pines, ThinkGen

Be Creative, but Know the Rules

Using primary survey research and secondary data to establish non-clinical promotional claims isn’t a new concept. Back in the 1970’s everyone was repeatedly exposed to the Trident chewing gum TV commercial claiming that “4 out of 5 dentists surveyed recommend Trident.” As a budding researcher at the time, I always wondered about the one dentist who didn’t recommend Trident, but that’s another story.

In today’s environment, using survey research to establish or substantiate a non-clinical claim requires not only thoughtfulness and creativity, so that the claim supports the brand strategy, but also a keen understanding of the evolving regulatory considerations required by the US Food and Drug Administration (FDA).

Companies striving to develop a promotional claim need to abide by an advancing set of rules and assumptions both in the design and conduct of the research, as well as in the eventual communication of the claim itself.

Start by Writing Your Aspirational Headline

If you’re considering using survey research or other data to establish a non-clinical promotional claim, start with the end in mind. Use this question to start: What is the headline we ultimately hope to generate?

Typical non-clinical claims amplify and socialize the perceptions, preferences, or experiences of customers. We've all seen these types of claims woven into consumer, direct-to-consumer pharma or HCP-oriented advertising. Such claims can speak to the percentage of doctors that would recommend a given product to their patients or their loved ones; the percentage that are satisfied with a product; and/or the percentage who would use/prescribe it again.

Envision yourself on a couch watching a new Fall TV series or an NFL game. Undoubtedly, post-election, every other ad is going to be for some pharmaceutical product. What headline do you think would both break through the noise and would also say something relevant, meaningful or even surprising about the product?

Also ask yourself:

• How would this claim fit in with the campaign?
• How does this claim fit in with the overall brand strategy?

It is therefore important to kick off the process of non-clinical claim development with a sit-and-think session to brainstorm the range of options to spotlight or reinforce a certain advantage of the brand. Once an inventory of potential claims is established, the next step is to apply the lens of what will eventually be acceptable to the FDA.

Know the FDA Regulatory Considerations

There are several key regulatory considerations that teams developing non-clinical claims through survey research need to keep in mind. FDA has oversight to scrutinize any promotional claim made by a company.?While the FDA regulatory reviewers focus on clinical claims, they can and will challenge any unsubstantiated claim, including a non-clinical claim, a company makes about its product.

There are fundamental differences when conducting research to support promotional claims versus the types of research we (i.e., those of us in the primary marketing research and insights business) typically conduct.?Usually we conduct “research to know.”? We conduct research to understand markets, gain reactions to product concepts or communication materials and generally support strategic and tactical decisions.

To support promotional claims, we are conducting “research to show.” We are conducting research to provide proof rather than provide knowledge.?As a result there are several considerations when conducting a marketing research study for the purpose of making non-clinical claims in external communications include:

• Sample sizes tend to be larger than other research.?Making a claim based on hundreds of participants carries significantly more weight than dozens of participants.?A sample size of 300 is more meaningful than one of 75 or 100 in supporting a promotional claim.?This is a case where more is better; not to improve precision, but to boost face validity.
• Sample frames tend to be broader and inclusive and more than just your target list of top decile customers. You want to have a study which is broadly representative of the overall market of HCPs or patients not just those you are currently targeting.
• Survey questionnaires are high structured and brief.?We recommend only including questions that will support the promotional claim itself.?This is not the survey vehicle to answer every question the marketing team might have.

In any promotional piece, the study design (sample and research methodology) should be adequately described (either in the body of the piece or in a footnote) so that the audience finds the claim believable.

While non-clinical claims testing research does not require submission to FDA’s Office of Prescription Drug Promotion (OPDP), it is subject to submission if requested by FDA.? The FDA may ask to see the data if the agency is concerned that the claim may be false or misleading or may have been developed with bias.

When it comes to the use of a claim in promotional materials, there are a host of considerations. Most importantly, any claim, even for non-clinical measures, must be supported by the approved labeling or consistent with the labeling.

Other evolving FDA perspectives that are relevant:

• In communicating the research externally, the FDA increasingly wants to the advertising to depict the actual numbers, not just general claims or percentages. For example, FDA has made clear that it prefers that the advertisement indicate “270 of 300 patients in a survey found drug X to be convenient to use,” as opposed to “patients found the product convenient," or "most patients found...", or "9 out of 10 of patients in a survey found…”
• Headlines on promotional pieces are clumsy when they use precise numbers rather than generalities such as "most," but if a generality is used, the actual numbers should be stated in close proximity to the generalization. For example, if a headline states, “most patients say that Product X is convenient to use," then there should be in close proximity a statement that "in a study, 270 of 300 patients (or 90% of patients) found Product X to be convenient," and there should be further detail, perhaps in a footnote, how the study was designed and conducted.
• If the marketing research survey covers a range of questions or topics, then when using the research for promotional purposes, care must be taken to avoid any concerns that only the data favorable to the brand are being cherry-picked.
• Comparisons with other products or superlative claims must be based on head-to-head data. In other words, the ad can’t say “the most convenient” unless there are data based on a valid head-to-head study comparing the product with other products within the same indication.
• The concept of how to depict comparative or superlative is especially important because claims like this usually are the most persuasive. Showing that your product is not just viewed by patients and HCPs as "convenient" is bolstered substantially by the claim that it is "more convenient" than other?drugs in the class. Any claim that a product is "preferred" is inherently a comparative claim and must be supported by valid head-to-head data. Comparative claims are the most likely to be scrutinized by FDA regulators, and competitors have various mechanisms to challenge such claims, including registering a complaint directly with the FDA.
• It is imperative not to disparage competitors in making non-clinical promotional claims. Disparagement increases the likelihood that there will be a reaction by the competitor. FDA's view is that a product that it has approved should not be subject to disparagement, since it is approved as safe and effective for certain patient populations and its use should not be subject to attack by a competitor.

A Range of Applications

Using survey research to support the development of non-clinical claims or other messaging can be applied to achieve a range of communications objectives, both on the branded side as well as unbranded.

One recent illustrative example where survey research was utilized to support a publicly-available unbranded educational message was where Apellis conducted a survey to show that patients wished they knew more about Geographic Atrophy (GA) at diagnosis. Specifically, their LinkedIN post stated:

• "83% of patients wish, at the time of diagnosis, they understood the irreversible impact GA would have on their vision."

Survey research can also be used to support a range of branded communication objectives by spotlighting an attribute of a product, by demonstrating a certain favorable customer attitude about the product, a degree of preference or loyalty, and/or to drive usage by crystallizing a favorable perception. In the development of a claim, the team needs to think about a headline that is simple and is going to impress customers.

Case Study: Hormone Replacement Therapy

Several years ago, members of the ThinkGen research team were involved in the marketing and promotion of an Estrogen Replacement Therapy (ERT) for treatment of menopausal symptoms. This ERT brand had a unique topical delivery system for estradiol that prescribing doctors initially viewed as awkward and potentially unwieldy by patients. The team also was struggling for its messaging to stand out in a crowded marketplace.

The marketing team decided to field a simple survey of product users to ascertain the percentage that would recommend it to a friend. This survey found that 100% of product users would recommend it to a friend. As a result of the survey, not only was this claim employed in personal promotion, it became the #1 most recalled message about the brand.

Of note, the fact that the survey produced such a high percentage – a perfect score, in fact – was part of what made the claim so compelling. As you think about developing a non-clinical claim for your brand, think about a question that would produce a very high percentage, if not 100%.

Conclusion

Establishing a non-clinical claim can help advance a team’s strategic goals, both in terms of unbranded and branded communications. Claims developed based upon survey research must fall within or be otherwise consistent with the product labeling and be provable, accurate, and the results, transparent. A survey should not and cannot disparage a competitor.

In developing a survey to achieve this, the team should seek opportunities where a very high percentage can be achieved in order for the claim to have an impressive and breakthrough impact. The team should strive to develop a claim that works with the campaign; is resonant, believable, and authentic; and will activate the intended behavior.

Non-clinical claims developed based upon survey research are also likely to be far more cost-effective, efficient, and timely than claims established from clinical research. And, when properly designed and executed, non-clinical survey-derived claims can move the needle in convincing physicians to prescribe and patients to request.

Perhaps most important is to work with an external consultant/agency that is expert not only in survey design and data collection methods, but also the intricacies and nuances of the evolving FDA regulations.