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21 CFR Part 11
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510(k) premarket notification
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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.

E

Early termination of a clinical trial

Early termination of a clinical trial means the premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with (Art. 2(2)(28) EU Clinical Trials Regulation 536/2014). It differs from a temporary halt, where the sponsor intends to resume, and from the normal end of a clinical trial.

Common causes include safety concerns raised by a data monitoring committee, demonstrated futility or overwhelming efficacy at an interim analysis, recruitment failure, funding or strategic decisions, and regulatory action. Under Art. 37(4) and 38 CTR, the sponsor must notify the early termination through CTIS within 15 days, state the reasons and, where relevant, the follow-up measures for subjects, and submit a summary of results within one year (or earlier where the trial is stopped for safety reasons).

Early termination does not end data protection obligations. Data already collected remains subject to the sponsor's retention duties under Art. 58 CTR and to pharmacovigilance follow-up; participants must be informed of the termination and of the consequences for their treatment and their data; and vendor contracts should specify what happens to hosted data, backups and access rights at wind-down. The DPIA should already anticipate the termination scenario, including the transfer of data to a successor sponsor if the asset is sold.

Can a sponsor treat early termination as an ordinary study close-out?

No. Early termination requires an assessment of the applicable notification and participant follow-up requirements, not just administrative closure. Explain why the trial ended and arrange safe ongoing care where needed. Retention and reporting duties can continue after recruitment and treatment stop, so do not instruct vendors to delete study records automatically.