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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.

I

Investigational Medicinal Product Dossier (IMPD)

The Investigational Medicinal Product Dossier (IMPD) is the regulatory document, submitted as part of a clinical trial application through CTIS, that provides information on the quality, manufacture and control of the investigational medicinal product, together with summaries of the non-clinical and clinical data supporting its use in the proposed trial (Annex I, Section G of the EU Clinical Trials Regulation 536/2014).

A full IMPD contains a quality section structured like the CMC module of a marketing application (drug substance, drug product, placebo and comparator), a non-clinical section (pharmacology, pharmacokinetics, toxicology) and a clinical section (previous human experience, benefit-risk assessment). Simplified IMPDs are accepted where the product is authorised in the EU, where information was already assessed in a previous application, or where the investigator's brochure can serve as the non-clinical and clinical summary. For GMO-based products, the environmental risk assessment is submitted in parallel to the environmental authority.

The IMPD is product documentation and generally contains no personal data beyond the names of manufacturers' responsible persons, but its clinical section summarises earlier trials and must be written from anonymised or aggregated results. Its commercial sensitivity makes it a key asset in the sponsor's information security programme, and the CTIS transparency rules require the sponsor to flag commercially confidential information and personal data before publication.