Claims for the consumer

Brands and raw material suppliers should collaborate to ensure claims are consumer focused

Brands and raw material suppliers should collaborate to ensure product claims are consumer focused rather than egocentric, suggests Theresa Callaghan

Without the needs of the consumer, the cosmetics industry would not be enjoying the success it continually generates – and yet often these needs are poorly addressed. Today’s consumers are not easily influenced by those promises of eternal youth or the like, nor are they easily influenced by cosmetic product claims. Although claims substantiation is an international legal requirement, translating new research findings into language the consumer understands without losing scientific integrity is an opportunity being missed by both brands and raw material suppliers.

The common practice, not solely within the supply base, of running cheap and cheerful studies to avoid costs means that all you will get back is cheap data and not so cheerful results. Failure to capture market opportunities is often driven by an unwillingness to spend, the choice of clinical studies and a lack of understanding about them, concern over the return on investment, and concerns about the requirements of regulatory and advertising standard authorities.

Dr Theresa Callaghan, Callaghan Consulting International

There is a disconnect between knowledge and understanding when it comes to claims development and claims substantiation, yet understanding studies is not an amalgamation of aeronautical engineering and astrophysics. A good quality study should: address a relevant important cosmetic question; have the ability to make an actual difference to consumers of the product(s) under test; use the best available clinical techniques; generate significant yet consumer relevant data; be scientifically and ethically sound; and recognise and ensure good clinical practice by both the customer and the contract research organisation (CRO).

If this is not the case, then the validity as well as the quality of the study in question can be regarded as vulnerable. Vulnerability often arises as a result of a lack of knowledge or real understanding of the goals, often as a result of a company culture that is entrenched in a certain ideology. Classic examples are the retailers and private label companies who rely on external input in the product development process.

Pressure on development deadlines and the lack of knowledge and discernment in the choice of external expertise (if sought) in order to help achieve their goals drives this vulnerability. Furthermore, a lack of understanding of product development and, in some cases, the CRO’s lack of keeping up to date with knowledge of the basic skin sciences also contributes.

Another factor is the failure to identify differing priorities. In addition, poor study design can diminish focus on the actual objectives of the study. Studies should be designed to generate claims rather than pulling a study off the shelf to fit the claim.

While innovation in pre-clinical studies, both in vitro and ex vivo, proceeds at lightening speed with every advantage taken, the same cannot be said of methods for clinical studies. Again this is often due to a lack of understanding which then generates false assumptions and ideas. It is surprising the number of marketing and R&D individuals who do not know, let alone understand, the regulatory requirements for launching the product(s) they are developing.

In addition, the project manager (as well as the technologist and formulator) is generally not an expert in clinical studies or claim substantiation and can often end being a jack of all trades, master of none. This can result in a loss of focus on the objectives and even exploitation by others.

Global brands need global studies. However although some CROs have set up their own international activities, there is at times a lack of understanding about the culture of local countries and clinical study requirements. EU or FDA requirements are often imposed without even a thought for national requirements that need to be incorporated.

Few development deadlines are actually achieved on time. Making changes to the critical path and bringing marketing on board early in understanding the objectives and requirements involved in a clinical study will ease pressure. Charging the CRO with “just do the study and give me the data” has only one outcome. Both offering and demanding guaranteed results from the CRO are illegal and of course corrupt and are often driven by risk aversion, a fear that a study will not be successful.

With regard to costs, inflexible limitations are often placed on resources available to run clinical studies without any thought or consideration for the objectives and outcomes of the studies and what benefits these studies bring. If the three key principles of claims substantiation (ie exact definition of objectives, transparency of objectives and data, and relevance of the test methods) are not clearly understood, then the data generated for claims development also becomes vulnerable.

The return on investment for cosmetic clinical studies is not just about cost versus benefit, and putting a financial value on an industry which thrives on emotion and vanity is laden with subtleties, value judgements and error.

The victim in all this is of course common sense. If both R&D and marketing shared the cost of running clinical studies, it would help both understand that neither should dominate the development process and realise the value of discussing the testing needs together. In addition, the development of a common language will help them remain consumer focused rather than egocentric.

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