Non-interventional studies (NIS) are a key tool for collecting information about how a drug is actually used (+ safety, effectiveness, healthcare benefit and value etc…) once it’s been approved (e.g., by FDA in the USA) and accepted for reimbursement (e.g., NICE in the UK).
NIS – Pains
The good news is, NIS study designs are relatively simple. The bad news is, the regulatory environment is complex…and dynamic – it’s prone to change. Hence, the ‘painful’ nature of getting these studies off the ground.
Things to Consider:
- The regulations and requirements that govern NIS differ in every country – globally
- The purpose of the study dictates the regulatory requirements e.g., the regulatory requirements for mandated post-approval commitments are different to those for voluntary non-interventional studies
- The study design dictates the regulatory requirements e.g., addition of PROs and questionnaires, non-routine bloodletting and biosamples, export of biosamples, collection of genetic information, collection of information on deceased patients etc., adds to the approval, submission and notification needs of these studies
- The safe harbour agreement on Data Privacy with the USA is no longer valid
- The regulations and requirements applicable to NIS change – often!
- What may be considered in ‘Non-Interventional’ in some countries will be considered ‘Interventional’ in others
- The regulations and requirements for disease registries differ (generally) from those relating to non-interventional studies (i.e., studies of drugs)