Getting Creative with Claims Development

Claims are a key communication vector of a product’s values and benefits, from commercial messages such as “No 1 recommended product” to certain packaging and format advantages, to more science-driven efficacy benefits such as “works faster” vs other products.

Although a claim usually consists of only a few words, it is the opportunity to explain the benefits of a product vs. other offerings and to convince consumers to make a purchase.

Exhibit 1 – Types of claims for consumer health products (Source – IQVIA Consumer Health)

Every claim, regardless of the type, must be substantiated.

Some regions of the world have adopted harmonized regulations governing claims substantiation; others have not. So local knowledge is very important to avoid later unpleasant surprises.

Depending on the goal of the claims development you can apply consumer science or clinical science.

As Exhibit 1 shows, consumer science claims can be established based on sales data and HCP recommendation surveys. Typically, this is something like “recommended by GPs” or “no 1 pain product in Spain”.

With more advanced real-world data research methods based on specific consumer surveys, you can gather claim-relevant information on perceived product effectiveness. Usually, you need at least 400 consumers participating in such surveys to get a statistically significant insight.

For clinical science claims, clinical research – especially when done as a RCTs - is the most scientifically rigorous and expensive approach. This is applied usually for label claims or new indications.

Real-world evidence provides another avenue to explore data reported directly from consumer (PROs) and can complement findings from RCTs to prove efficiency in a real-world context.

Clinical or real-world research is usually required for products claiming health or disease reduction benefits and such research is highly scrutinized by regulatory authorities. So again, it is important to design such trials or RWE approaches very carefully.

In any case, claims must mirror consumer needs – otherwise all the investments will not provide the returns expected. The more the science is approached in a consumer-centric way, the more you can be assured that you are doing the right things.

Why disrupt the claims development status quo?

Exhibit 2 – Filling the evidence gap between RCTs and the real world (Source – IQVIA Consumer Health)

RCTs are the gold standard in clinical research to prove safety and efficacy of a product. However, RCTs are limited by the fact they are generally done in an ‘artificial and controlled environment’ – which is not representative of a real-world situation and how consumers ultimately use the products.

It has become evident that in real-life situations, a lot of factors such as nutrition, lifestyle, and co-medication, influence the outcome of an intervention compared to what is picked up by an RCT (see Exhibit 2).

Bridging such gaps with additional information that better describes the value of a product in a real-world context is not a bad idea. This approach is already used consistently in the pharma industry and regulators are encouraging such real-world approaches.

In Consumer Health, Real-World Evidence (RWE) can derive from multiple data resources outside of the typical clinical settings - including information from DTC questionnaires and digital health tools.

With this we get closer to the heart of consumers and can achieve a new quality of consumer-centric claims.

Bring the consumer closer to your brands

Exhibit 3 – Generating stronger claims by engaging consumer through digital platforms (Source – IQVIA Consumer Health)

Consumer health brands are built on trust. Well established brands are trusted by those that use them to provide the safety and efficacy they expect when tackling a minor illness.

Today’s challenge is to uncover the secrets to consumer trust and that requires asking the right types of questions – What do consumers think about your product vs. competitors?; How are they really using your products?; What are they wanting from healthcare products? - and the ability to capture meaningful data around the answers.

Nowadays, consumers are not looking for just a product, they want solutions to their specific problem; it must fit their lifestyle and deliver meaningful benefits – and recently the expectations on additional diagnostic tools and personalization are increasing (Exhibit 3).

Unearthing these consumer secrets is important to increasing value share and product innovation.

Applying digital technologies is the key to success on this journey.

Bridging the gap with digital technology

Exhibit 4 – Using digital to change study/trial approaches (Source – IQVIA Consumer Health)

With new methods such as social media listening, data mining, real-world evidence, and digital health data deriving from wearables and smartphones you can transform your claims substantiation process.

Furthermore, by combining such approaches with AI and machine learning, the process of unearthing and substantiating consumer relevant, impactful claims can become even faster, more efficient, and more accurate.

Social Media Listening for example is providing valuable consumer insights unfiltered by research intervention. Monitoring what’s being said online by regular consumers can reveal candid insights in near real-time. The data can be used to identify new consumer needs (see Exhibit 4).

Prof. Christensen from Harvard University discovered that “… product developers focus too much on consumer profiles and correlations unearthed in data, and not enough on what customers are trying to achieve in a particular circumstance”.

With smart technologies such as SML you can come closer to this information in a cost and time efficient manner.

By adopting these approaches, you get a better idea of what consumers want and what consumers want to read or hear in terms of a claim. Based on such information you can improve the design of a real-world study with more relevant survey questions targeting consumer perceived evidence claims in line with expressed needs. These findings can then be used to make strong commercial claims.

In clinical or real-world hybrid studies we can include digital biomarkers, observational data and behavior data to achieve more consumer related outcomes, which can then be used to develop new label claims and new indications.

Such approaches are a huge opportunity for the industry that has not been sufficiently explored. By getting “digital” we can also run most of the studies completely virtually.

Update your R&D toolbox

Exhibit 5 – Integrating digital biomarkers to uncover new health claims and indications (Source – IQVIA Consumer Health)

Integrating data from different sensors housed in smartphones, wearables, or dedicated devices – such as thermometers – enable you to generate digital biomarkers from the raw data from sensors measuring activities such as movement, rotation, and position.

Such raw data can be translated into information on number of steps, arm movements, sleep related movements and overall physical activity. These can be important digital biomarkers demonstrating the efficiency of health products across categories such as

• In the case of smoking cessation, you will have an objective measurement of the smoking frequency.
• And for a calming product you can gain new insights on how the sleep quality improved by taking a certain product.
• If treating a cold, you can learn about the evolution of coughing frequency and severity via using sound recording paired with AI (see Exhibit 5).

Such digital information is also objective and can be measured passively in a continuous manner meaning it is very convenient for study participants.

Digital endpoints can be used to generate new claims around effectiveness as well as comparative claims and may even lead to the discovery of new indications, opening up a new frontier in consumer health to be explored.

Integrating new approaches

Exhibit 6 – Claims strategy model which integrates digital (Source – IQVIA Consumer Health)

To start with a claim strategy, you should do a “white space” analysis to understand consumer / medical needs and insights but also the competitive landscape and regulatory requirements.

The strategy also depends on the type of claims you are targeting, either label / clinical claims or promotion / advertising claims.

In any case you need to apply the most appropriate methodology allowing the development of claims that:

• Resonate with consumers
• Clearly differentiate the product in the market
• Can be substantiated at a cost in line with the value delivered
• Can pass regulatory or legal scrutiny.

Best practice is to have a company-wide claims strategy that crosses product categories and product lines.

By applying technology, you can “simplify the difficult” and generate claims that can help your products stand out from the crowd.

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