What is the difference between non-interventional research and market research?
EphMRA (European Pharmaceutical Market Research Association) provides a detailed overview of the differences between market research (MR), non-interventional studies (NIS) and patient support programmes (PSP) within its Code of Conduct (section 1.3) available on the EphMRA website. Link to guidance
EphMRA point to the following key distinction:
“Non-interventional research studies involve the collection of ‘additional data post-authorisation. Such post-authorisation measures may be aimed at collecting data to enable assessment of the safety or efficacy of medicinal products in the post-approval setting. Market Research is carried out for a commercial purpose i.e. to investigate customer behaviours and market opportunities, to inform business decision making, clinical endpoints are not needed for market research.”
Non-interventional research does require ethics approval.