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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.

P

Protocol

A protocol means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial; the term encompasses successive versions of the protocol and protocol modifications (Art. 2(2)(22) EU Clinical Trials Regulation 536/2014). Annex I, Section D of the Regulation and ICH E6 GCP section 6 list the required content: background and rationale, objectives and endpoints, design, selection and withdrawal of subjects, treatment, assessment of efficacy and safety, statistics, direct access to source data, quality control, ethics, data handling and record keeping, financing and insurance, and publication policy.

The protocol is approved by the ethics committee and competent authority through CTIS; substantial modifications require a new authorisation, and deviations are recorded and assessed as potential serious breaches. Sponsors are increasingly encouraged to use structured protocol templates (TransCelerate, ICH M11) and to include a lay synopsis for publication.

Section 13 (or its equivalent) on data protection and confidentiality is the part iliomad reviews most often. A well-drafted section identifies the controller and its EU representative, describes pseudonymisation and the custody of the key, names the categories of recipients (CRO, vendors, regulators), specifies international transfers and their mechanisms, states retention periods, and addresses special topics such as eDiaries, photography, genetic data and future use of samples, consistently with the informed consent form and the DPIA. Where the protocol is global, each paragraph should be labelled with the regions to which it applies (EU/EEA, UK, Switzerland, US).