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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.

U

Unexpected serious adverse reaction (SUSAR)

An unexpected serious adverse reaction means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information (Art. 2(2)(34) EU Clinical Trials Regulation 536/2014). Three cumulative elements are therefore required: the event is serious (see serious adverse event), there is at least a reasonable possibility of a causal relationship with the investigational medicinal product (making it a reaction rather than an event), and it is not listed, or is more severe or specific than described, in the reference safety information (RSI) contained in the investigator's brochure or the summary of product characteristics.

Suspected unexpected serious adverse reactions (SUSARs) are subject to expedited reporting by the sponsor to the EudraVigilance database under Art. 42 CTR: within 7 days for fatal or life-threatening SUSARs (with follow-up within a further 8 days) and within 15 days for all others. SUSARs occurring in trials of the same active substance conducted outside the EU must also be reported. Investigators are informed of SUSARs relevant to subject safety, and all suspected serious adverse reactions are summarised in the annual safety report under Art. 43. In the United States the equivalent is the IND safety report under 21 CFR 312.32.

SUSAR reports are individual case safety reports (ICSRs) in E2B format containing detailed clinical information on an identified subject. They are health data processed under legal obligation and public health (Art. 6(1)(c) and 9(2)(i) GDPR), exempt from erasure and retained for the life of the product plus 10 years. Reports must be pseudonymised (no names or full dates of birth) and limited to medically relevant information, and the safety database vendor and any CRO performing pharmacovigilance act as processors. Transmission to EudraVigilance is a disclosure to the EMA, supervised by the EDPS; transmission to a non-EU sponsor headquarters or partner is an international transfer requiring appropriate safeguards.