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21 CFR Part 11
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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.

G

Genetic data

Genetic data means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question (Art. 4(13) GDPR). Recital 34 specifies that this includes chromosomal, DNA and RNA analysis and any other analysis enabling equivalent information to be obtained.

Genetic data is a special category of personal data under Art. 9. Processing requires an exception such as explicit consent or scientific research with appropriate safeguards (Art. 9(2)(j) and Art. 89), and Art. 9(4) expressly allows Member States to maintain further conditions, which many have done: France requires specific consent for genetic testing and restricts germline data use, Germany has the Gendiagnostikgesetz, and several countries regulate biobanks separately.

Genetic data has three features that make it particularly sensitive: it is intrinsically identifying and essentially impossible to anonymise once whole-genome sequences are involved; it reveals information about biological relatives who have not consented; and it may predict future health, with implications for insurance and employment. Genomic sub-studies in clinical trials, biobanking for future research, pharmacogenomics and direct-to-consumer testing therefore demand a dedicated DPIA, tiered consent, strict access governance and careful framing of incidental findings and re-contact.