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Imported item 10
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Imported item 12
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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.

F

Imported item 39

A first-in-human (FIH) trial is the first clinical investigation in which an investigational medicine is administered to humans. It marks the transition from nonclinical development to human testing. Depending on the product and risk assessment, participants may be healthy volunteers or patients; FIH does not describe a medicine’s novelty within its class.

Key takeaways

  • FIH concerns first human exposure, not first-in-class status.
  • Participant selection depends on the product and risks.
  • Early safety decisions rely on planned evidence review and controls.

Where FIH Fits in Development

The EMA early-trial risk guideline addresses uncertainty, starting-dose justification, dose escalation and risk mitigation. The FDA clinical research overview describes Phase 1’s focus on safety and dosage. These concepts overlap, but FIH and Phase 1 are not interchangeable labels for every protocol: an early trial may combine several study parts.

ConceptDistinction
First-in-humanFirst administration of the investigational medicine to humans.
Phase 1An early development phase commonly examining safety and dosage.
First-in-classNovelty relative to a therapeutic or mechanistic class.

Why It Matters for Data Protection

As an operational recommendation, design the study’s data flow alongside its safety-review process. Specify who receives laboratory results, who can link study codes to participants and how urgent findings reach authorised clinicians. Limit unnecessary identifiers without obstructing legitimate safety decisions. These are operational design recommendations, not a dosing or medical management protocol.

Hypothetical example: A sponsor plans sequential dose cohorts. Its team recommends testing the hand-off between the laboratory, site and safety reviewers before enrolment, including whether the right people can see the required results in time. The data-flow review records responsibilities without distributing the site’s identification list to every reviewer.

Frequently Asked Questions

Are FIH participants always healthy volunteers?

No. The product and clinical context may justify enrolment of patients.

Is a first-in-class medicine necessarily in its FIH trial?

No. First-in-class describes novelty, not the current development stage.

Can a privacy review replace the safety assessment?

No. Data protection design supports the study workflow; scientific and medical risk assessment remains separate.

Related reading: clinical trial phases, first-in-class drugs.

For practical implementation, explore clinical trial data protection support.

Updated: 27 October 2026