Without consumers and their needs, the cosmetic industry would not be enjoying the success it continually generates, yet often, consumers’ needs do not even get a look-in.
Admittedly marketers acknowledge that they are the ones that create consumers’ needs, but today’s consumers are not easily influenced by promises of eternal youth or the like, and even if they are not academically ‘in the know’, more often than not most of them have generated knowledge in which social media has certainly played a large role in recent years. As judged in the press and social media, today’s consumers are not easily influenced by cosmetic product claims. The international legal requirement that active ingredients and final formulae require claims substantiation means that neither R&D nor marketing can drop this responsibility solely onto one another. Moreover, an inability to both ‘understand’ and to ‘translate’ new research findings into language the consumer understands without losing scientific integrity, is an opportunity being missed by many brands, and the same can be said for the raw material supplier communicating with the brands. The age old issue of the battle of wills between marketing departments and R&D makes you wonder that since both functions are integral to the development of business success, why can they not work in harmony together? R&D always complain that marketing are only useful for developing (late) launch plans rather than coming up with new products, and that they are obsessive about certain features and benefits of the products, and one more thing, they do not listen. On the other hand, marketing complain that R&D fails to include them up-front in the development process, does not understand them and takes all the credit for a product succeeding, while denying any culpability if a product fails. Is it any wonder then that the development and execution of product claims either seem ‘lost in space’ or ‘lost in translation’? Failure to capture market opportunities is often driven by cost and an unwillingness to spend, choice of clinical studies and lack of understanding, concern over the return on investment, and concerns over regulatory and advertising standards authorities. Whether the industry likes it or not, ingredients or a finished formula require claims substantiation and neither supplier nor customer can pass the responsibility over to one another, and it is disappointing to regularly hear some industry individuals actually encouraging this. The common practice not solely within the supply base of running ‘cheap and cheerful’ studies to avoid costs, and then pass-the-buck, means that is all you will get back – cheap data and often not so cheerful results. The supplier who is convinced the consumer is solely the responsibility of their customer needs to know and understand the consumer as real, not just that face in the crowd. Reviewing the claims and clinical projects executed for clients highlights a clear common underlying theme – namely a disconnect between what marketing desire based on their understanding of the ‘need’, the scientific data generated, claims promoted by raw material suppliers and R&D’s interpretation of that data, legislation, the formulation chemist, the clinical testing company or department, and both knowledge and common sense. Substantiation testing is legally required when the claim refers to the effectiveness of a product or a benefit or improvement in a skin attribute as a result of using that product. Making a claim does not mean that a product is effective. Efficacy indicates product performance (not necessarily related to the desired claim, nor necessarily correlating with any other data), while communicating efficacy is making a claim which needs to be proved. Claims themselves can be divided into three main categories:
• Cautious, for example: ‘Contains vitamin E known for its antioxidant properties’ (even if you only put in a few molecules). • Extreme: any unsubstantiated claim (uncorrelated data, incorrect substantiation, incorrect conclusions, animal efficacy data – including in vitro studies, etc.). • ‘Woolly’/vague, for example: ‘Neurocosmeceutical Soother’ (legally means nothing).
These categories can be further subdivided:
• Empty: ‘…approved by dermatologists’ (does this mean the principle investigator or was the product assessed by a team/board of credible dermatologists?).• Unfinished: ‘...lip gloss does it with more shine’ (does what with more shine?)• Different/unique: ‘There’s no other mascara like it’ (was the clinical study conducted versus every mascara on the planet?). • Vague: ‘...your skin blossoms overnight’. • Endorsement: Jane Fonda, etc. (Jane Fonda has had plastic surgery and is in her 70s. Is the product she is endorsing, for elderly skin or elderly skin that has plastic surgery?).• Scientific/statistical: ‘78% of users liked it’ (Liked what?).• Complimentary: ‘...because you’re worth it’.• Question: ‘Could your skin use a miracle?’ (The skin is a miracle!).
Clearly 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 GCP at both the customer and 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 lack of knowledge and real understanding of the goals – this in itself often arises from company culture issues which are difficult to change once they are entrenched in a certain ‘ideology’. Classic examples are the retailers and private label companies who rely on external input in the product development process. Technologists and project managers may be well versed in formulation and manufacturing but equally are missing crucial expertise in the basic skin sciences and clinical understanding. 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, the lack of product development understanding, and even in some cases, lack of keeping up-todate with the basic skin sciences knowledge at the CRO, the lack of information from their customer concerning the entirety and point of the product concept, why certain ingredients were chosen, also contributes to this vulnerability. Further areas of vulnerability are:
Failure to identify priorities
Marketing are often too focused on their ‘desires’ rather than the requirements of the objectives, particularly if they do not either understand the objectives of the study and/or were not informed of the study objectives. R&D in turn, make satisfying marketing their priority and the real objective becomes the victim.
Poor study design
This involves diminishing focus on the actual objectives of the study as well as the financial and expertise resources available to achieve the quality necessary for transparency of objectives. The ‘one size fits all’ mentality – often related to a lack of understanding of the requirements and objectives of the study in order generate the claim(s). Studies should be designed to generate claims, not ‘we have the claim, design us a study to fit’. Pulling a study off the shelf to fit a claim is poor quality and ignorance on the part of both the CRO and its customer.
Few development deadlines are actually achieved on time. By 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 in the normal ‘panic’. Charging the CRO with ‘just do the study and give me the data’ has only one outcome.
Division of roles in project management
The project manager (and also the technologist and formulator) is not an expert in clinical studies and claim substantiation, and often can end up being a ‘jack-of-all-trades, master-of-none’. This can then result in loss of focus on the objectives, and even exploitation by others.
Globalisation of clinical studies
With the world becoming a smaller place, the global market has increased exponentially. With global brands comes the need for global studies. Although some CROs have set up their own international activities, there is at times a lack of understanding of the local country’s culture and requirements to running studies. Often EU or FDA requirements are imposed without even a thought for any national requirements that need to be incorporated.
The fear that a study will not be successful and thus a poor return on investment can drive the demand for ‘guaranteed results’ from the CRO. Both offering and demanding guaranteed results is illegal and obviously corrupt. Risk aversion is also driven by lack of knowledge and lack of understanding of the study objectives.
Repression of innovation
Repression of innovation, such as preconceived ideas and assumptions, is seen in both clinical research and product development. Furthermore, the resistance (or paltry implementation) to accepting either new clinical approaches or new technologies diminishes badly-needed advancements in clinical study design. While innovation in pre-clinical studies, both in vitro and ex vivo proceeds at lightning 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.
Misunderstanding the regulatory requirements
It is surprising the number of marketing individuals who do not know, let alone understand, the regulatory requirements for launching the product(s) they are developing. It is even more surprising the number of R&D individuals who do not understand either, and therefore are not in a position to discuss objectively with their regulatory team or the legislators when required to do so.
Cost of clinical studies
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, i.e. 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:
• Have studies appropriately specified and measured the product/ingredient that is the subject of the claim? • Have studies appropriately specified and measured the problem that is the subject of the claim?• Are conclusions about the product/ problem relationship based on the totality of available scientific evidence?
Unfortunately, cosmetic clinical trials are, more often than not, constructed on poor quality and/or non-relevant pre-clinical research data. The consequent lack of correlation of data is an industry-wide problem and affects the major multinationals as it does the small, seemingly insignificant companies. Important questions to keep in mind are: What are you/they selling/claiming? What is the mechanism of action? How was it tested? What concentrations of the ingredient were used? Were proper controls in place? Are/were the methods clearly described? Is the data valid and relevant? Is all of the data being presented? Is relevant statistical significance demonstrated? Does the generated data support the suppliers conclusions? How will this ingredient work in the final formulation – what pre-formulation work and proof of principle testing has been conducted? How does/will this impact on final formulation clinical testing? More often than not, these questions are either not considered or they are overlooked, resulting in serious claims errors versus, for example, in vitro generated data. Many high street cosmetic claims bear absolutely no resemblance to what the raw material suppliers are actually communicating!
With innovation and demands for high return on investment (ROI) products, development paths are becoming increasingly challenging, inefficient, and a waste of resources. The ROI 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 judgement, and error. Simultaneously, the rate of legislative development work has not kept up with the rapid advances in so-called ‘cosmetic science’, resulting in a technological disconnect between scientific developments and the product development process. Cosmetic technology performance is actually measured in terms of product safety and effectiveness, and the applied sciences required for product development have not kept pace with lightning advances in the basic sciences. New scientific discoveries are not being used to guide the technology development process as they are in accelerating the technology development process. Furthermore, there has been and still is insufficient applied scientific work to create new clinical tools and methods to fundamentally answer how the effectiveness of new products can be demonstrated faster, with more certainty, and more cost effectively. Thus, the path to market is viewed as inefficient, due in part to reliance on the cheapest option driven by a lack of strong practical expertise across all functions. Expectations always run higher than reality and often pressure is put on the clinical testing companies to ‘guarantee’ results, which is corrupt, immoral, unethical and actually illegal. The victim in all this is of course common sense. Both R&D and marketing need to understand each others’ value in this process and how they each complement one another. Obviously marketing need to understand that they are a major stakeholder in the outcomes of cosmetic clinical studies since they are, in essence, a ‘dress rehearsal’ for product performance in the hands of the consumer. If R&D and marketing shared the cost of running clinical studies, it would help both understand that neither of them can dominate the development process, and the value of discussing the testing needs together. Joint monitoring and discussions with the testing company/department helps all parties involved, not least the testing company/department, since they are not always in a position to clearly understand formulations or basic skin research discoveries. Furthermore the development of a common language together will help them remain consumer focused rather than egocentric.
This article was originally presented in part at in-cosmetics 2012, Marketing Trends, Barcelona, Spain.
AMA Laboratories is a clinical testing and claim support laboratory based out of New City, New York. Specializing in SPF, UVA, Infrared, Safety, and Hypoallergenic Testing, Instrumental Analysis, and Visual Claim Support via PhotoGrammetrix®.AMA offers a unique bridge between scientifically backed efficacy reporting and cutting edge...
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