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21 CFR Part 11
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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.

C

Clinician-reported outcome (ClinRO)

A clinician-reported outcome (ClinRO) is a type of clinical outcome assessment in which a trained healthcare professional reports on a patient's health condition using clinical judgement or interpretation of observable signs, behaviours or other physical manifestations. Unlike a patient-reported outcome, it does not capture the patient's own perception, and unlike a biomarker it involves professional interpretation.

Examples include physician global assessments, clinician-rated depression scales such as the Hamilton Depression Rating Scale, the Psoriasis Area and Severity Index, tumour response according to RECIST criteria, and neurological examinations scored on standardised scales. Because ClinROs depend on the rater, trials invest in rater training, calibration and inter-rater reliability, and sometimes use central raters to reduce variability.

ClinRO data is data concerning health about the participant, but it also generates personal data about the clinician (identity, qualifications, rating performance), which is used for quality oversight and may be shared with the sponsor and regulators. Both data streams need to be covered in the trial's DPIA and in the information provided to participants and site staff.

Can a clinician-reported outcome substitute for the patient’s own symptom report?

Not automatically. A ClinRO reflects a trained professional’s assessment of observable signs or behaviour, whereas a PRO records the patient’s own report. Choose the measure according to the concept being assessed. A clinician’s interpretation should not be presented as the patient’s unmodified experience of symptoms such as pain.