Explanation of Key Principles
B. What Constitutes Market Research
The term 'market research' is used throughout the Code but it is recognised that the market research function may go under different names in different organisations eg consumer/market insight, business/commercial intelligence, marketing/data analytics, customer science. Market research is used in this Code as an 'umbrella' term that describes the work meeting the definition.
With the broadening of market research options both in terms of new methods eg behavioural economics and new mediums eg mobile devices, there is a need to provide a Code that is applicable t both traditional and the newer non-traditional approaches such as digital listening.
Market research, whatever it is call and whatever approach is used, is defined by the following key characteristics:
- the systematic gathering and interpretation of information about individuals, organisations or market places
- using the information gathering and analytical methods and techniques of the applied social, behavioural and data sciences
- its purpose is to gain insight or support decision making
- the identity of MR subjects will not be revealed to the user of the information without explicit consent (and can never be revealed in Germany), market research has no interest in the individual identity of MR subjects
- no direct action eg a sales approach will be taken in relation to individuals or organisations as a result of the market research (except following up adverse events when permitted) market research is not a commercial communication or a selling opportunity.
Based upon the definition of market research contained in the ICC/ESOMAR International Code 2007
Market research is defined by the objective(s) and the approach, not by the title of the work or those involved in it. Consequently the EphMRA Code of Conduct includes areas such as digital listening (the use of social media content for market research), the use of observational/ethnographic approaches and work carried out online via mobile devices.
Advisory boards may or may not qualify as market research depending how they are run. An advisory board is generally a group that provides non-binding strategic advice to the management of an organisation eg providing expert advice on new drugs and opportunities. If the advisory board is recruited and operated as market research - meeting the definition above - then it is market research.
Secondary Data Use
If the secondary data includes personal data, its intended use MUST be compatible with the purpose for which the data was originally collected. The intended use must not be specifically excluded within the privacy notice provided at the time of the original data collection.
Market Research, Ethics Approval and Non-Interventional Research3.4
Market research does not require Clinical Research Ethics Committee or Independent Review Board approval.
Market research (as defined above) relating to market or consumer behaviour of the sort that pharmaceutical companies routinely commission, whether involving healthcare professionals, patients, carers or members of the public does not require Clinical Research Ethics Committee or Independent Review Board approval (Institutional Review Board in the USA).
Key regulators have made it clear what distinguishes ‘research’ that requires ethics approval i.e. clinical/medical research from ‘research’ that does not i.e. market research.
EFPIA require non-interventional research studies to meet specific criteria that are not required of market research:
- The study is conducted for a scientific purpose
- There is a written protocol
- The study protocol MUST be approved by, and the study conduct supervised by, the Company’s Scientific Service.
- The study results should be analysed and made available within a reasonable period of time to the Company’s Scientific Service and the Healthcare Professionals who participated in the study
- If the study shows results that are important for the assessment of benefit-risk profile of the medicinal product, the summary report should be immediately forwarded to the relevant Competent Authority
- Companies publicly disclose the summary details and results of non-interventional studies in a manner consistent with the parallel obligations for clinical trials
- Companies apply the same requirements (to the extent applicable) to all other types of studies including epidemiological studies, registries and other studies that are retrospective in nature
UK NHS Guidelines
The UK National Health Service Health Research Authority (NHS HRA) provides a decision support tool to help determine whether a study should be classified as 'research' or not:
- Are patients randomised to different groups?
- Is there a protocol to be followed?
- Are the results generalisable* to the population?
* Generalisable is defined as the extent to which the findings of a clinical study can be reliably extrapolated from the subjects who participated in the study to a broader patient population and a broader range of clinical settings.
In addition, the NHS HRA provide a leaflet ‘Defining research’ that is designed to help you decide if a project is research, which normally requires review by a Research Ethics Committee (REC), or whether it is some other activity such as audit, service evaluation or public health surveillance.
Indeed in the UK, Governance arrangements for research ethics committees A harmonised edition published by the Department of Health, May 2011 states that:
"2.3.14 Healthcare market research may be undertaken by professional market researchers on behalf of pharmaceutical or medical device companies. Where such research is conducted by professional market researchers in accordance with the Legal and Ethical Guidelines issued by the British Healthcare Business Intelligence Association (BHBIA), it does not require REC review except where otherwise required by law".
In addition, EphMRA provides a detailed overview of the differences between market research (MR), non-interventional studies (NIS) and patient support programmes (PSP) – see table in Section 3.8. Key differentiating characteristics between MR and NIS are:
|Commercial focus/purpose (market behaviour and opportunities) – internal focus||Y||N|
|Clinical or medical focus/purpose (safety, efficacy or pharmacokinetics) – external focus||N||Y|
|Epidemiological methods must be used to design the study and analyse the data||N||Y|
|Must generate scientifically significant evidence||N||Y|
|Managed by company’s scientific/medical service (rather than commercial)||N||Y|
Confusion between market research and clinical/medical research can arise because they sometimes address the same audience, may use a similar tool – a questionnaire, and can ask similar questions. In particular, non-interventional studies (or post-marketing authorisation studies as they may also be called) are confused with market research.
Non-interventional research studies involves the collection of "additional data post-authorisation, as it is necessary from a public-health perspective to complement the available data with additional data about the safety and, in certain cases, the efficacy of authorised medicinal products. Such post-authorisation measures (PAMs) may be aimed at collecting data to enable the assessment of the safety or efficacy of medicinal products in the post-approval setting.”
Non-interventional research is carried out for a clinical purpose i.e. to assess safety, efficacy or tolerability, its ultimate purposes are to advance science, the treatment of disease and improve patient outcomes. In contrast, market research is carried out for a commercial purpose i.e. to investigate market behaviour and opportunities to inform business decision making. Clinical endpoints are not needed for market research.
Even market research that involves the collection of anonymised patient data detailing conditions, symptoms and treatments this does not mean it is non-interventional research. Market research using anonymised patient record data is analysed in aggregated form to generate information upon market patterns.
The distinction between market research and non-interventional research applies whether the market research involves prospective or retrospective patient data.
The following table distinguishes between the characteristics of market research, patient support programmes and non-interventional studies.
Difference Between Market Research, Patient Support Programmes and Non-interventional Studies:
|Information gathering tool||Y||N||Y|
|Patient or carer service||N||Y||N|
|Participants remain anonymous||Y||N||Y or N|
|Direct Patient benefit||N||Y||N|
|Directly impacts clinical care||N||Y||N|
|Pooled processing of information generated||Y||N||Y|
|Participants are generally financially incentivised||Y||N||N|
|Impacts patient directly and immediately||N||Y||N|
|Generally generates scientifically significant information||N||N||Y|
|Requires clinical research ethics committee approval||N||N||Y|
|Can be prospective or retrospective||Y||N||Y|
|Always involves marketed product||N||Y||Y|
|Managed by company's scientific service (rather than commercial)||N||Y or N||Y|
|Generally includes patient prescribed a company's medicinal product in the usual manner||N||Y||Y|
|Epidemiological methods must be used to design the study and analyse data||N||N||Y|
MR Market Research
PSP Patient Support Programme
NIS Non-interventional Study
Non-Market Research Activities and Purposes3.9
It is not market research when data are collected for any other purpose that that described (see 3.1). In general non-research exercises have the following characteristics:
- Anonymity and confidentiality are not guaranteed
- If the data are collected on an identifiable basis, direct action (such as selling or direct marketing) will or may be taken
- The exercise aims primarily to encourage people in general or at random to express views, rather than to achieve robust data based on systematically targeting specific sectors of the population or on the whole range of views from a representative sample of the relevant population.
- The exercise promotes the aims or ideals of a client or organisation
- The exercise promotes the products or services of a client or organisation
These definitions are based upon the UK’s Market Research Society’s Regulations for Using Research Techniques for Non-Research Purposes Nov 2010
Database building is a non-research purpose. Data Protection legislation prohibits information given within a market research exercise being used to build a database unless consent for this was given at recruitment.
Combining Research and Non-Research Activities3.10
When researchers are fulfilling their role as researchers they MUST NOT conduct other non-research activities without the prior informed consent of MR subjects. In Germany the MR industry guidelines state that market research may not be combined with non-research activities. Market research should be clearly separated and distinguished from any other activity.
- At recruitment and in the introduction to the MR explain clearly what is involved
- Justifiable business need and market research objectives are clearly documented
- The minimum sample size and an appropriate sample structure is used
- Appropriate incentives to the time, tasks and types of MR subject are given
- Guide/questionnaire and stimulus design is balanced
- There is no unnecessary use of brand names or over-emphasis upon claims or product messages, particular care should be taken if the names of unlicensed products are to be used
- The use of stimulus is clearly sign-posted at recruitment and in the introduction to the MR
- MR subjects are made aware that the stimulus is non-promotional and for the purposes of the market research alone
- If stimulus refers to a marketed or an unlicensed product this is made clear
- The number of times the stimulus is shown is limited to the minimum
- If repeated exposure is required, explain why this is necessary
- Only essential personal data is collected and the necessity for this is explained
- Market research is not run alongside a non-research exercise
Market research MUST NOT be used to obtain confidential information about competing products and companies from MR subjects who are bound by confidentiality agreements with those companies.
Client and Agency3.13
In terms of the EphMRA Code of Conduct the client is the commissioning party and the agency executes the study on their behalf. Generally but not necessarily the client is a manufacturer of pharmaceuticals, devices or diagnostics and the agency is a market research specialist. It is recognised that for some studies there may be more than one ‘client’ (e.g. different offices may be involved) and more than one ‘agency’ involved (e.g. a co-ordinating global agencies and local fieldwork suppliers). In which case for the purposes of the EphMRA Code the following definitions apply:
- Client = commissioning company head office or regional office or local affiliate/office, these may be pharmaceutical medicine manufacturers, producers of devices or over-the-counter medicines etc.
- Agency = full service market research agency, fieldwork agency, independent recruiter, freelance researcher or interviewer – these may be the main contractor or a sub-contractor. Agencies may also include marketing or management consultancies, PR or advertising companies that run market research studies
The following key points should be noted:
- All parties involved should be contractually bound in a chain e.g. if pharma company X’s HQ has commissioned international full service agency Y to carry out a multi-country market research study on their behalf and agency Y has sub-contracted fieldwork to fieldwork agency Z who has in turn sub-contracted recruitment of MR subjects to recruiters A, B and C in three different countries – then, it is expected that the full service agency Y will be under contract to company X, the fieldwork agency will be under contract to agency Y, and finally the recruiters A, B and C will be under contract to fieldwork agency Z.
- Sub-contractors should be bound by the same legal and ethical requirements as the main contractor.
- For data protection purposes original holders of personal data can, if contractually bound, pass personal data to other parties without seeking the explicit consent of the individuals as long as the data is being used for a purpose for which the original holder has a lawful basis to process the personal data, such as the consent of the individual.
Agencies may not transfer MR subjects’ personal data to the client without the explicit consent of the MR subjects. In Germany MR industry guidelines state that MR subjects must remain anonymous to the client. Consequently personal data must never be made available to the commissioning client company unless it can be guaranteed that client personnel will not (now or in the foreseeable future) be able to identify the individuals. Requesting MR subject consent to override this is prohibited too.