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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.

Y

Yellow Card scheme (UK)

The Yellow Card scheme is the United Kingdom's national system for collecting reports of suspected adverse drug reactions, incidents involving medical devices, defective or counterfeit medicines, and safety concerns about e-cigarettes, run by the Medicines and Healthcare products Regulatory Agency (MHRA). Established in 1964 following the thalidomide tragedy, it accepts reports from healthcare professionals, patients, carers and companies through the Yellow Card website, app, integrated clinical systems and the industry gateway, and is the UK counterpart of EudraVigilance and the FDA's MedWatch. Since Brexit, UK reports are no longer routed through the EU system, so marketing authorisation holders must report UK cases to the MHRA directly under the Human Medicines Regulations 2012, with a UK QPPV responsible for the UK pharmacovigilance system.

The MHRA uses Yellow Card data for signal detection, benefit-risk assessment and regulatory action, publishes interactive Drug Analysis Profiles, and shares data with the WHO Uppsala Monitoring Centre. Reporters are asked for the suspected product, the reaction, the patient's age, sex and (optionally) initials or a local identifier, relevant medical history and outcome, and their own contact details for follow-up. The scheme emphasises that reporters need not be certain of causality: suspicion is enough, and under-reporting remains its main limitation.

Yellow Card processing is governed by the UK GDPR and the Data Protection Act 2018, with the MHRA as controller relying on its public task and the public health condition for special category data. Patient identity is minimised (no names or full dates of birth are collected), reporter details are kept confidential and are not passed to companies without consent, and pharmaceutical companies receiving anonymised case data for their products must handle it under their own pharmacovigilance and data protection procedures. For a non-UK sponsor or marketing authorisation holder, UK safety reporting is one of the processing activities that requires a UK representative under Art. 3A UK GDPR and should be reflected in the RoPA and transfer documentation alongside EU reporting to the EMA. iliomad acts as UK Data Protection Representative for life sciences companies.