Key Research Stages – During Fieldwork
K. Instrument and Stimulus Design and Use
Questionnaire and Question Design6.1
Researchers should take reasonable steps to ensure that:
- Questions are fit for purpose and clients have been advised accordingly
- Questionnaire design and content are appropriate for the audience being researched
- MR subjects are able to answer the questions in a way that reflects the view they want to express, including don’t know/prefer not to say where appropriate
- MR subjects are not led towards a particular answer
- Answers are capable of being interpreted in an unambiguous way
- Personal data collected is relevant and not excessive.
Market research materials should not:
- Raise unfounded hopes for a treatment
- Mislead MR subjects with regard to the performance of a product
- Encourage members of the public to ask a healthcare professional for a particular product or healthcare professionals to use or recommend a product - disguised promotion is prohibited.
When a topic is considered sensitive, MR subjects MUST be told explicitly the subject and content of the discussion. Sensitive topics include those that are judged to be sensitive to most people or a specific group of people because of the nature of the subject or those that may be sensitive to a particular individual, because of that individual’s past history.
When sensitive topics are to be discussed, the MR subject MUST be made fully aware of:
- The topic for discussion prior to the interview
- The fact that they need not answer all of the questions posed
- Their right to withdraw at any point in the recruitment or interview process.
In cases where the subject under discussion is gender specific or of a sensitive or potentially embarrassing nature, MR subjects should be interviewed by interviewers of the same sex, or given the choice to be so.
Stimulus material includes any material shown during the course of fieldwork e.g. product profiles, branding concepts, packaging materials.
Stimulus material should be fit for purpose. Pharmaceutical industry codes of practice generally require that information claims and comparisons be accurate, balanced, fair, objective, and unambiguous, be an up-to-date evaluation of all the evidence and they should not mislead either directly or by implication, by distortion, exaggeration or undue emphasis – the same is expected of stimulus material.
Within any market research care should be taken to ensure that MR subjects understand when they are providing feedback on draft materials, hypothetical scenarios, assumptions, a product in development or as yet unlicensed.
In the Netherlands, MOA affiliated researchers MUST NOT use stimulus with healthcare professionals that includes brand names or indications for unlicensed products. The use of samples of prescription only medicines is also prohibited in market research.
In Finland, the PIF Code of Conduct states market research MUST not focus upon a medicinal product which has not obtained marketing authorisation.
Where required (country requirement and company policy) stimulus materials to be used within market research should be approved by the client company's medical department prior to use (irrespective of format or finish).
All stimulus materials should be collected at the end of the interview.
Additional ABPI guidelines for stimulus material content and format for the UK are detailed within the BHBIA’s Legal & Ethical Guidelines http://www.bhbia.org.uk/guidelines/legalandethicalguidelines.aspx.
Use of Product Names9.1
The unnecessary or repeated use of brand names should be avoided unless assessing reaction to the name, or use of the product by name is an essential research objective - particular care should be taken if the names of unlicensed products are to be used.
The use of brand names when researching hospital products (‘H’ drugs) with patients in Italy although not explicitly forbidden would be considered unethical. The Spanish Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals requires that there is no link between the product tested and a company, so product testing should be blinded.
Testing Products and Devices10.1
Companies should generally refer to their medical and regulatory departments for guidance on market research surveys that involve testing products and/or devices.
It is strongly recommended that placebos are used during market research surveys whenever practical.
Guidance for testing products via market research varies depending on the category a medication falls into:
- Licensed prescription-only medicines taken in line with the product license can only be taken by a MR subject who is an existing user of the product and if a registered medical practitioner is present.
- If a product is licensed but the MR subject is asked to use the product outside of its approved indication(s)/dosing/formulation i.e. as an ‘investigational product’ during a market research survey, it is recommended that the research is carried out according to Good Clinical Practice (GCP) guidelines. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf
- If the product is unlicensed, Good Clinical Practice (GCP) guidelines MUST be followed when undertaking a market research survey. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf In Mexico these are published by the regulator COFEPRIS at http://www.cofepris.gob.mx/AZ/Documents/Farmacovigilancia/Buenas%20pr%C3%A1cticas%20de%20Farmacovigilancia%20para%20las%20Am%C3%A9ricas.pdf
If subjects are taking non-prescription drugs (i.e. over the counter - OTC) products during market research surveys, it is recommended that an appropriate healthcare professional is present.
For market research involving medical devices only (i.e. there is no active product involved), if the device is not CE marked, is an implantable device, is to be used outside the approved license or could potentially cause a patient harm (e.g. use of a needle is involved), the commissioning client company’s medical department MUST approve the market research approach, confirm whether the Guidelines on Medical Devices (MEDDEV 2.7/4) need to be followed and whether an appropriate healthcare practitioner should be present.
When the client entrusts products to an agency researcher’s care, the client commits them self to providing products compliant with laws in force and to give all the necessary information on these products, providing in particular correct information on the directions for use, the ingredients/components list and the transport and storage conditions. Moreover, the client MUST take the necessary measures to provide the researcher with any constraints relating to the security of the products.
Clients are fully responsible for all damage or injury caused by materials or products they have provided to researchers for research purposes unless the researcher failed to follow the care instructions provided by the client - when the materials were in the agency's possession (or the agency breached any other legal obligations).
As with stimulus material, products and devices (active or placebo) should be collected at the end of the interview.
10.8 Adverse Event reporting requirements associated with medical devices should be agreed with the Marketing Authorisation Holder before commencing any market research survey.