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Randomised clinical trial (RCT)
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Zero trust architecture
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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.

S

Subject (clinical trial participant)

A subject means an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control (Art. 2(2)(17) EU Clinical Trials Regulation 536/2014). The terms "participant" and "trial participant" are increasingly preferred in patient-facing documents and in ICH E6(R3), but "subject" remains the legal term in the Regulation and in FDA regulations. Healthy volunteers in Phase I trials are subjects as much as patients in later phases.

Chapter V of the CTR sets out the protection of subjects: informed consent (Art. 28 to 30), special rules for incapacitated subjects (Art. 31), minors (Art. 32), pregnant or breastfeeding women (Art. 33), emergency situations (Art. 35) and, under national law, other vulnerable groups such as persons in detention or in dependent relationships. Subjects may withdraw at any time without detriment, must be able to contact an independent point of information, and are covered by compensation arrangements (Art. 76).

Every subject is also a data subject under the GDPR. Their identity is known to the investigator site, which acts as controller for source records and holds the pseudonymisation key; the sponsor processes pseudonymised health data as controller for the trial dataset. The two capacities are governed by different rules: withdrawal of consent to participate stops new procedures and data collection, whereas the data protection rights over data already collected are shaped by Art. 58 CTR retention, GCP integrity and the Art. 89 research safeguards. The informed consent form should explain both dimensions clearly.

Does being called a trial ‘subject’ change a participant’s protections?

No. The terminology does not remove protections such as appropriate ethics review and informed consent under the applicable framework. In participant-facing materials, ‘participant’ is often clearer. Explain the person’s choices, study procedures and contacts in understandable language rather than relying on regulatory labels to communicate their rights.