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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.

P

Personal data

Personal data means any information relating to an identified or identifiable natural person, the data subject; an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person (Art. 4(1) GDPR).

The definition is deliberately wide and the Court of Justice reads it that way: information "relates to" a person by its content, purpose or effect (Nowak, C-434/16), dynamic IP addresses can be personal data (Breyer, C-582/14), and identifiability is assessed against all means reasonably likely to be used, taking into account cost, time and technology (Recital 26). Subjective opinions, inferences and profiles are personal data; so are data that are inaccurate. Only information about deceased persons, legal entities and truly anonymous data fall outside.

The consequence for life sciences is that pseudonymised data, including coded clinical trial data held by a sponsor who cannot itself re-identify participants, remains personal data because the investigator holds the key (Recital 26 and EDPB Guidelines 01/2025). Genomic sequences, medical images, rare-disease registries and rich real-world datasets are personal data regardless of the absence of names. Treating coded data as "anonymous" in contracts, consent forms or transfer analyses is one of the most frequent and consequential errors in the sector.