Key Topic 4: Market Research and Non interventional studies

When reviewing market research the following key principles should be kept in mind:

  • There must be a genuine business need
  • It must never be, or appear to be, promotional in nature
  • Consider whether the research should be blinded
  • The rights of respondents must be respected (confidentiality, privacy, consent etc)

In general terms, a non-interventional study is observational in nature. The product is prescribed in the usual manner, in accordance with the terms of the marketing authorization, without any additional investigations, monitoring or interventions. The decision to treat is taken separately from the decision to include the patient in the study.
Collected data should undergo formal analysis.

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Non-Interventional Studies must address a scientifically and medically valid question to which AstraZeneca needs the answer.

Valid questions might include:

  • Safety and/or effectiveness
  • Medical practice and drug utilisation
  • Disease and clinical epidemiology
  • Burden of disease
  • Costs and Quality of Life
  • Patient reported outcomes
  • Compliance/adherence to therapeutic regimen

Any decision to conduct a Non-Interventional Study must be based on genuine scientific need. Non-Interventional studies are never conducted to influence prescribing practice.

All the principles of the Good Clinical Practice IGH guideline apply, including the need for informed consent and collection of adverse event data if the study involves use of an AZ product.

Consider these examples:

Genuine business need for market research?

In the UK a complaint was made by a health professional about a market research survey and letter sent on behalf of Merck Sharp & Dohme. The questionnaire enabled the recipient to nominate those physicians from whom he/she sought medical guidance/ knowledge in specified therapy areas.

It was stated in the letter that the information would be used to help structure future medical educational programmes according to need.

The complainant was worried that the company was paying them to send it information regarding other doctors who could then be contacted in a similar unsolicited way.

The letter stated that the nominated colleagues and the addressee would be invited to ‘speak at or take part in relevant professional meetings, scientific partnerships and research initiatives’ and that the information received would be used to ‘deliver tailored information to you and them’. Physicians might also be approached for their knowledge of a specific disease area and its environment. The questionnaire asked for details of local and regional asthma and allergic rhinitis specialists.

Do you think this is a reasonable question to ask in a market research survey? Does there appear to be a genuine business need here?

Yes No

 
×

Ruling

The UK Authority did not consider that it was unacceptable for Merck Sharp & Dohme to have commissioned market research to validate its understanding of networks in asthma and allergic rhinitis.

Promotional market research?

In the US the FDA issued a warning letter regarding some activities undertaken by Schering with respect to their product Vancenase nasal spray.

The FDA said that Schering had disseminated misleading promotional messages during promotional presentations that Schering had called ‘research’. Schering had misrepresented the nature of the activities. The FDA had videos that showed company representatives making numerous statements that ‘promoted Schering’s drug products as being superior to its competitor products’. They also stated that the presentations made were more like ‘detailing a group of health care providers’ than market research. For example 37 slides with introductory or technical information were presented in a one- hour session.

In the letter the FDA made some interesting statements about market research versus promotion as follows:

 
  1. The natural defensiveness by which people process promotional messages was circumvented by the presentation of the messages as ‘research’
  2. It is well established that participants in research studies are likely to be highly sensitive to, and compliant with, information presented in a research environment
  3. Materials presented as educational in nature are more fully accepted and integrated into the research participants personal belief systems than material clearly identified as promotional

Schering were ordered to deliver a ‘corrective campaign’ in ‘communication formats with similar impact’.

Disguised promotion?

In the UK a consultant neurologist complained about a survey headed ‘Neurology Pharmaceutical Survey’ sent by a market research agency which consisted of two pages of 22 questions and sub-questions. Most of the questions related to the use of botulinum toxin injections. Six of the questions specifically referred to the use of botulinum toxin injections for the treatment of primary headache or migraine.

The identity of the commissioning pharmaceutical company was not clear from the documentation. The agency confirmed that it was Allergan. Allergan marketed Botox (botulinum toxin). Botox was not licensed for the treatment of primary headache or migraine.

Allergan said that the purpose of the survey was to seek information and opinion from senior health professionals actively involved in the management of primary headache and migraine.

 

The information gained would ensure that Allergan’s communications were effectively targeted. The survey had been sent to over 800 clinicians.

One question asked which was the respondent’s preferred brand and named each botulinum toxin injection brand available in the UK. Another question similarly named all the brands. None of the botulinum toxin injections currently marketed were licensed for the treatment of primary headache or migraine.

Another question asked

‘Are you currently aware of the use of botulinum toxins for any type of primary headache or migraine?’

The next question asked clinicians to choose which one of four statements best described their usage intentions of botulinum toxins for headaches/migraine assuming that such a use was officially approved. The third statement read ‘I am not interested in trying botulinum toxins for headache/migraine patients, neither injecting them or referring them, unless they become a very common and successful treatment for headache/migraine’

 

Which of the following do you agree with?

  • This is unacceptable as the questions are about an unlicensed indication
  • Sending a market research survey to 800 clinicians is unlikely to be considered acceptable
  • The nature of the questions may stimulate interest in an unlicensed indication
  • This is disguised promotion
  • This is likely to be viewed as off-label promotion
Check answer Ruling
×

The UK Authority considered that the nature of the questions and the survey’s broad distribution to over 800 clinicians was such that it went beyond merely seeking information and opinion from senior clinicians actively involved in the management of primary headache and migraine conditions as submitted by Allergan. The questions would stimulate interest in the use of botulinum injections for an unlicensed indication. In the Panel’s view the survey was a marketing tool and not genuine market research. The Panel ruled that the material at issue promoted botulinum toxins in the guise of a survey. In that regard the promotional activity was disguised.