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A brief introduction to market research and clinical research and how to use each discipline for best results When to use market research and when to use clinical research How to use market and clinical research together to develop claims
Introduction to Clinical Research Medicinal Products Disease Treatment Food Supplements Promotion of Health Each have own legislation and/or guidelines to govern study requirements and conduct Human intervention studies Cosmetics Appearance Enhancement 3
Clinical Trials of Medicinal Products Means an investigation in human subjects, other than a non-interventional trial intended: a) To discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products b) To identify any adverse reactions to one or more such products or c) To study absorption, distribution, metabolism and excretion of one or more such products, With the object of ascertaining the safety or efficacy of those products The Medicines for Human Use (Clinical Trials) Regulations 2004 4
Phase of Clinical Trials Phase I First-in-human trials Small number of subjects How the treatment works in the body Min-max doses Phase II Patient studies Several hundred people Identification of common side effects Dose and treatment refinement Phase III Several thousand patients More detailed data for prescribing and patient information Phase IV Post marketing Long term effects New uses 5
Clinical Trial Process Set-up Protocol research objective(s), study design, comparator, minimisation of bias, how data will be analysed, all other details related to the conduct of the study Research site Trial materials test products, documentation, equipment Approvals Ethics, Regulatory, local site In-clinic Trial initiation Subject recruitment Intervention, study assessments and data collection as detailed in the protocol Oversight and monitoring Reporting Data management Statistical analyses Written report Submission/publication/communication Generally lengthy and expensive 6
Food Supplement Claims Article 2 of Regulation (EC) 1924/2006 Nutritional States, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a particular nutrient or other substance Such as source of calcium, low fat, high fibre, reduced salt Health States, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health Such as calcium helps maintain normal bones Also more general claims such as good for you Any new health claims under the scope of 1924/2006 would have to be substantiated and approved for inclusion of the list 7
Substantiation of Beauty Claims for Food Supplements Appearance linked to beauty AND it is not a claim that states, suggests or implies that a relationship exists between a food category, a food or its constituents and health (Art 2.2.5) falls outside scope of 1924/2006 Examples improve/maintain/increase* the appearance or structure of hair (resistance, volume and thickness, glossy/shiny hair, silky hair) or the appearance of wrinkles (decrease in wrinkles) Helps to improve skin elasticity, skin surface structure Helps to improve skin tonicity, skin firmness * depending on clinical trial results 8
Why do market research? Who Users Consumers Patients Shoppers Customers Doctors Pharmacists Specialists What Attitudes Beliefs Feelings Behaviours Motivations Why New Product Existing product performance Communications development Price change Promotions performance 9
Market research is good for Learning about people that use/buy/sell your brand Understanding how you are performing against the competition Learning about market trends 10
How can we find out what we need to know about the consumer? EXTERNAL SOURCES e.g. industry data, competitors, adjacent markets INTERNAL SOURCES e.g. brand data, management information Insights team RESEARCH e.g. market research, trends analysis CONSUMER CLOSENESS e.g. meeting or watching real people 11
Different types of market research Quantitative Qualitative Which and How big Who and Why Size an opportunity Measure likely purchase 100-1000 respondents Attitudes, behaviours Thoughts, feelings 20-50 respondents