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Dr Theresa M. Callaghan: Claims development and consumer understanding
1. Dr Theresa M. Callaghan – Callaghan Consulting International, Germany TESTING
Claims development and
consumer understanding
Without consumers and their needs, the
cosmetic industry would not be enjoying
Montage: www.freestockphotos.biz / www.stockfreeimages.com
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 “You too can look younger...”
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. Today’s consumers are not easily influenced by cosmetic product claims.
The international legal requirement that
active ingredients and final formulae is often driven by cost and an unwillingness when the claim refers to the effectiveness
require claims substantiation means that to spend, choice of clinical studies and of a product or a benefit or improvement
neither R&D nor marketing can drop this lack of understanding, concern over the in a skin attribute as a result of using that
responsibility solely onto one another. return on investment, and concerns product. Making a claim does not mean
Moreover, an inability to both ‘understand’ over regulatory and advertising standards that a product is effective. Efficacy
and to ‘translate’ new research findings authorities. Whether the industry likes it indicates product performance (not
into language the consumer understands or not, ingredients or a finished formula necessarily related to the desired claim,
without losing scientific integrity, is an require claims substantiation and neither nor necessarily correlating with any other
opportunity being missed by many brands, supplier nor customer can pass the data), while communicating efficacy is
and the same can be said for the raw responsibility over to one another, and making a claim which needs to be proved.
material supplier communicating with it is disappointing to regularly hear some Claims themselves can be divided into
the brands. industry individuals actually encouraging three main categories:
The age old issue of the battle of wills this. The common practice not solely within ɀ Cautious, for example: ‘Contains
between marketing departments and the supply base of running ‘cheap and vitamin E known for its antioxidant
R&D makes you wonder that since both cheerful’ studies to avoid costs, and then properties’ (even if you only put in a
functions are integral to the development pass-the-buck, means that is all you will few molecules).
of business success, why can they not get back – cheap data and often not so ɀ Extreme: any unsubstantiated claim
work in harmony together? R&D always cheerful results. The supplier who is (uncorrelated data, incorrect
complain that marketing are only useful for convinced the consumer is solely the substantiation, incorrect conclusions,
developing (late) launch plans rather than responsibility of their customer needs to animal efficacy data – including in vitro
coming up with new products, and that know and understand the consumer as studies, etc.).
they are obsessive about certain features real, not just that face in the crowd. ɀ ‘Woolly’/vague, for example:
and benefits of the products, and one Reviewing the claims and clinical ‘Neurocosmeceutical Soother’
more thing, they do not listen. On the projects executed for clients highlights a (legally means nothing).
other hand, marketing complain that clear common underlying theme – namely
R&D fails to include them up-front in the a disconnect between what marketing These categories can be further subdivided:
development process, does not understand desire based on their understanding of ɀ Empty: ‘…approved by dermatologists’
them and takes all the credit for a product the ‘need’, the scientific data generated, (does this mean the principle
succeeding, while denying any culpability if claims promoted by raw material suppliers investigator or was the product
a product fails. Is it any wonder then that and R&D’s interpretation of that data, assessed by a team/board of credible
the development and execution of product legislation, the formulation chemist, the dermatologists?).
claims either seem ‘lost in space’ or ‘lost clinical testing company or department, ɀ Unfinished: ‘...lip gloss does it with
in translation’? and both knowledge and common sense. more shine’ (does what with more
Failure to capture market opportunities Substantiation testing is legally required shine?).
June 2012 P E R S O N A L C A R E 39
2. TESTING
ɀ Different/unique: ‘There’s no other being a ‘jack-of-all-trades, master-of-none’.
mascara like it’ (was the clinical study This can then result in loss of focus on the
conducted versus every mascara on objectives, and even exploitation by others.
the planet?).
ɀ Vague: ‘...your skin blossoms overnight’. Globalisation of clinical studies
ɀ Endorsement: Jane Fonda, etc. (Jane With the world becoming a smaller
Fonda has had plastic surgery and is in place, the global market has increased
her 70s. Is the product she is endorsing, exponentially. With global brands comes
for elderly skin or elderly skin that has the need for global studies. Although some
plastic surgery?). CROs have set up their own international
ɀ Scientific/statistical: ‘78% of users activities, there is at times a lack of
liked it’ (Liked what?). understanding of the local country’s culture
ɀ Complimentary: ‘...because you’re and requirements to running studies. Often
worth it’. EU or FDA requirements are imposed
ɀ Question: ‘Could your skin use a without even a thought for any national
miracle?’ (The skin is a miracle!). requirements that need to be incorporated.
www.commons.wikimedia.org
Clearly there is a disconnect between Risk aversion
knowledge and understanding when it The fear that a study will not be successful
comes to claims development and claims and thus a poor return on investment
substantiation, yet understanding studies is can drive the demand for ‘guaranteed
not an amalgamation of aeronautical results’ from the CRO. Both offering and
engineering and astrophysics. A good demanding guaranteed results is illegal
quality study should: address a relevant and obviously corrupt. Risk aversion is also
important cosmetic question; have the With the world becoming a smaller place, the driven by lack of knowledge and lack of
ability to make an actual difference to global market has increased exponentially. understanding of the study objectives.
consumers of the product(s) under test;
use the best available clinical techniques; the objectives, particularly if they do not Repression of innovation
generate significant yet consumer relevant either understand the objectives of the Repression of innovation, such as
data; be scientifically and ethically sound; study and/or were not informed of the preconceived ideas and assumptions, is
and recognise and ensure GCP at both the study objectives. R&D in turn, make seen in both clinical research and product
customer and CRO. satisfying marketing their priority and the development. Furthermore, the resistance
If this is not the case then the validity as real objective becomes the victim. (or paltry implementation) to accepting
well as the quality of the study in question either new clinical approaches or new
can be regarded as vulnerable. Vulnerability Poor study design technologies diminishes badly-needed
often arises as a result of lack of knowledge This involves diminishing focus on the advancements in clinical study design.
and real understanding of the goals – this in actual objectives of the study as well as While innovation in pre-clinical studies,
itself often arises from company culture the financial and expertise resources both in vitro and ex vivo proceeds at
issues which are difficult to change once available to achieve the quality necessary lightning speed with every advantage taken,
they are entrenched in a certain ‘ideology’. for transparency of objectives. The ‘one size the same cannot be said of methods for
Classic examples are the retailers and fits all’ mentality – often related to a lack clinical studies. Again this is often due
private label companies who rely on of understanding of the requirements and to a lack of understanding which then
external input in the product development objectives of the study in order generate generates false assumptions and ideas.
process. Technologists and project the claim(s). Studies should be designed to
managers may be well versed in formulation generate claims, not ‘we have the claim, Misunderstanding the
and manufacturing but equally are missing design us a study to fit’. Pulling a study off regulatory requirements
crucial expertise in the basic skin sciences the shelf to fit a claim is poor quality and It is surprising the number of marketing
and clinical understanding. Pressure on ignorance on the part of both the CRO individuals who do not know, let alone
development deadlines and the lack of and its customer. understand, the regulatory requirements
knowledge and discernment in the choice for launching the product(s) they are
of external expertise (if sought) in order to Development deadlines developing. It is even more surprising the
help achieve their goals drives this Few development deadlines are actually number of R&D individuals who do not
vulnerability. Furthermore, the lack of achieved on time. By making changes to understand either, and therefore are not
product development understanding, and the critical path and bringing marketing on in a position to discuss objectively with
even in some cases, lack of keeping up-to- board early in understanding the objectives their regulatory team or the legislators
date with the basic skin sciences knowledge and requirements involved in a clinical when required to do so.
at the CRO, the lack of information from study will ease pressure in the normal
their customer concerning the entirety and ‘panic’. Charging the CRO with ‘just do Cost of clinical studies
point of the product concept, why certain the study and give me the data’ has only Inflexible limitations are often placed on
ingredients were chosen, also contributes one outcome. resources available to run clinical studies
to this vulnerability. without any thought or consideration for
Further areas of vulnerability are: Division of roles in project management the objectives and outcomes of the studies
The project manager (and also the and what benefits these studies bring.
Failure to identify priorities technologist and formulator) is not an If the three key principles of claims
Marketing are often too focused on their expert in clinical studies and claim substantiation, i.e. exact definition of
‘desires’ rather than the requirements of substantiation, and often can end up objectives, transparency of objectives and
40 P E R S O N A L C A R E June 2012
3. TESTING
data and relevance of the test methods, are either not considered or they are effectiveness of new products can be
are not clearly understood, then the data overlooked, resulting in serious claims demonstrated faster, with more certainty,
generated for claims development also errors versus, for example, in vitro and more cost effectively. Thus, the path to
becomes vulnerable: generated data. Many high street cosmetic market is viewed as inefficient, due in part
ɀ Have studies appropriately specified claims bear absolutely no resemblance to to reliance on the cheapest option driven
and measured the product/ingredient what the raw material suppliers are actually by a lack of strong practical expertise
that is the subject of the claim? communicating! across all functions. Expectations always
ɀ Have studies appropriately specified run higher than reality and often pressure
and measured the problem that is the Conclusion is put on the clinical testing companies
subject of the claim? With innovation and demands for high to ‘guarantee’ results, which is corrupt,
ɀ Are conclusions about the product/ return on investment (ROI) products, immoral, unethical and actually illegal.
problem relationship based on the development paths are becoming The victim in all this is of course
totality of available scientific evidence? increasingly challenging, inefficient, and a common sense. Both R&D and marketing
waste of resources. The ROI for cosmetic need to understand each others’ value
Unfortunately, cosmetic clinical trials are, clinical studies is not just about cost versus in this process and how they each
more often than not, constructed on poor benefit, and putting a financial value on complement one another. Obviously
quality and/or non-relevant pre-clinical an industry which thrives on ‘emotion’ marketing need to understand that they
research data. and vanity, is laden with subtleties, value are a major stakeholder in the outcomes
The consequent lack of correlation of judgement, and error. of cosmetic clinical studies since they are,
data is an industry-wide problem and Simultaneously, the rate of legislative in essence, a ‘dress rehearsal’ for product
affects the major multinationals as development work has not kept up with performance in the hands of the consumer.
it does the small, seemingly insignificant the rapid advances in so-called ‘cosmetic If R&D and marketing shared the cost
companies. Important questions to science’, resulting in a technological of running clinical studies, it would help
keep in mind are: What are you/they disconnect between scientific both understand that neither of them can
selling/claiming? What is the mechanism developments and the product dominate the development process, and
of action? How was it tested? What development process. Cosmetic technology the value of discussing the testing needs
concentrations of the ingredient were performance is actually measured in together. Joint monitoring and discussions
used? Were proper controls in place? terms of product safety and effectiveness, with the testing company/department helps
Are/were the methods clearly described? and the applied sciences required for all parties involved, not least the testing
Is the data valid and relevant? Is all of product development have not kept pace company/department, since they are not
the data being presented? Is relevant with lightning advances in the basic always in a position to clearly understand
statistical significance demonstrated? sciences. New scientific discoveries are formulations or basic skin research
Does the generated data support the not being used to guide the technology discoveries. Furthermore the development
suppliers conclusions? How will this development process as they are in of a common language together will help
ingredient work in the final formulation – accelerating the technology development them remain consumer focused rather
what pre-formulation work and proof of process. than egocentric. PC
principle testing has been conducted? Furthermore, there has been and still
How does/will this impact on final is insufficient applied scientific work to ɀ This article was originally presented in
formulation clinical testing? create new clinical tools and methods part at in-cosmetics 2012, Marketing
More often than not, these questions to fundamentally answer how the Trends, Barcelona, Spain.
drstraetmans Beauty created
by nature.
Supported by
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June 2012 P E R S O N A L C A R E 41