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Term of the Day

Natural history study

A natural history study is a preplanned observational study intended to track the course of a disease over time, identifying demographic, genetic, environmental and other variables that correlate with its development and outcomes in the absence of intervention, or under standard of care. Designs may be retrospective (chart review of existing records) or prospective (longitudinal follow-up of a cohort or registry).

Natural history data is particularly important in rare and paediatric diseases, where randomised placebo-controlled trials may be infeasible or unethical. The FDA (guidance on rare disease natural history studies, 2019) and the EMA accept well-designed natural history studies to define endpoints and biomarkers, identify patient subgroups, estimate sample sizes and, in some cases, serve as external or historical control arms for single-arm trials supporting orphan products.

Because they are non-interventional, natural history studies fall outside the CTR and are governed by national law (for example France's MR-003 or MR-004 reference methodologies) and by the GDPR. They typically involve secondary use of medical records, long-term follow-up, genetic data and small populations in which anonymisation is rarely achievable, so pseudonymisation, a DPIA and a robust research legal basis under Art. 9(2)(j) are essential. Registries maintained by patient organisations or academic consortia raise additional questions of joint controllership and data access governance.

I

International data transfer

An international data transfer is the disclosure or making available of personal data by a controller or processor subject to the GDPR to another organisation located in a third country outside the EEA or to an international organisation. The EDPB Guidelines 05/2021 set three cumulative criteria: the exporter is subject to the GDPR, it discloses data to a distinct importer, and the importer is in a third country or is an international organisation. Remote access from a third country is a transfer; a data subject uploading their own data is not.

Chapter V of the GDPR allows transfers only on one of three footings: an adequacy decision (Art. 45), appropriate safeguards such as standard contractual clauses or binding corporate rules (Art. 46), or one of the narrow derogations in Art. 49 (explicit consent, contract necessity, important reasons of public interest, vital interests), which cannot be used for systematic transfers. Since the Schrems II judgment, safeguards must be accompanied by a transfer impact assessment and, where local law undermines protection, supplementary measures.

Clinical research is transfer-intensive by nature: a European trial for a US sponsor involves flows to the sponsor, its CRO, central labs, imaging vendors, EDC hosts, safety databases and regulators. Each flow should be mapped, assigned a mechanism and disclosed to participants in the informed consent form. The UK GDPR and the Swiss FADP have parallel but distinct transfer regimes (UK IDTA and Addendum; Swiss SCC amendments), and non-EU regulators such as the FDA are not "adequate" recipients, so transfers to them typically rely on Art. 49(1)(d) public interest.