Clinical development
Non-Pharmacological Interventions (NPIs)
Adapted physical activity, nutritional interventions, psychotherapy, therapeutic education, digital health solutions: health interventions without a drug, whose effectiveness is assessed with the same methodological rigour — protocol, consent, ethics committee, analysis plan — but with questions of their own: standardising the intervention, blinding that is difficult or impossible, measuring participant adherence.
🛠️ Infographic in progress — coming soon
Regulatory frameworks
- WorldwideNo "product" regulator: recognition comes through good-practice recommendations (WHO, learned societies) and systematic reviews · universal ethical foundation: Declaration of Helsinki, local ethics committees · NPIS Model evaluation framework and NPI registry
- European UnionNo dedicated NPI regulation · an intervention relying on medical-purpose software falls under Regulation (EU) 2017/745 (MDR) · GDPR — Regulation (EU) 2016/679 for data · national pathways for digital therapeutics (e.g. DiGA in Germany)
- FranceLoi Jardé depending on the level of constraint: most often RIPH 2, sometimes RIPH 1 "outside health products" (ANSM authorisation) or RIPH 3 if purely observational · opinion of an ethics committee (CPP) in all cases · NPI assessment by the HAS
- BelgiumLaw of 7 May 2004 on experiments on the human person · opinion of an accredited ethics committee · written consent for interventional studies
A field we intend to move into. No NPI study behind us yet — but the skills involved are exactly the same as on the other categories. We are looking for the first project.