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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

Genetically modified organism (GMO)

A genetically modified organism (GMO) is an organism, other than a human being, in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination (Art. 2(2) of Directive 2001/18/EC on the deliberate release of GMOs; Directive 2009/41/EC on contained use). Techniques covered include recombinant DNA methods, direct introduction of heritable material and cell fusion; the Court of Justice (C-528/16) has confirmed that organisms obtained by newer mutagenesis techniques such as CRISPR are GMOs unless a specific exemption applies.

In life sciences, the GMO framework bites on clinical trials of gene therapies, oncolytic viruses, viral-vector vaccines, genetically modified cell therapies (for example CAR-T) and bacteriophage products. Before or alongside the CTR authorisation, the sponsor must obtain a GMO authorisation or notification from the competent environmental authority in each Member State, supported by an environmental risk assessment. Procedures are national and heterogeneous, although the Commission has published common application forms and good practice documents to reduce delays.

The GMO dossier is largely product-focused rather than personal, but the trial itself generates genetic data and long-term follow-up data on treated subjects, often for 15 years or more for gene therapies under EMA guidance. This extended follow-up requires retention, re-contact and transfer arrangements to be planned in the DPIA and the informed consent form from the outset.