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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.

R

Randomisation and trial supply management (RTSM)

Randomisation and trial supply management (RTSM) is the current industry term for the validated software systems that manage participant randomisation and treatment assignment together with the forecasting, inventory, shipment and dispensing of investigational medicinal products across depots and sites in a clinical trial. RTSM platforms are the successors of IVRS and IWRS and are often grouped under the generic label interactive response technology.

Core functions include subject screening and enrolment tracking, implementation of the randomisation schedule with stratification and blocking, kit assignment preserving the blind, automated resupply triggers based on enrolment forecasts and expiry dates, temperature excursion management, drug accountability and returns, cohort management in adaptive designs, and emergency unblinding with audit trails. Integration with EDC, eCOA and clinical trial management systems avoids duplicate entry. Systems are validated under GAMP 5 and 21 CFR Part 11 and reviewed during GCP inspections.

RTSM systems process pseudonymised participant data (subject number, randomisation date, stratification variables, dispensing history) and personal data of site and depot users. The vendor is a processor under an Art. 28 GDPR agreement; because it holds treatment assignments, confidentiality and access segregation between blinded and unblinded roles are critical security measures. Hosting location and sub-processors determine transfer requirements, and the system should appear in the trial's processing register and DPIA.

What access controls matter most in an RTSM system?

Separate access according to trial duties and blinding requirements. Staff who manage supplies or review treatment allocation may need permissions that blinded investigators must not have. During setup, test role permissions, emergency unblinding and audit trails against the protocol, including what connected systems reveal when information is transferred between them.