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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.

W

World Health Organization (WHO)

The World Health Organization (WHO) is the specialised agency of the United Nations responsible for international public health, established in 1948 and headquartered in Geneva, with six regional offices and 194 Member States. It sets norms and standards, coordinates the response to health emergencies under the International Health Regulations (2005), maintains classifications such as the International Classification of Diseases (ICD-11) and the Anatomical Therapeutic Chemical (ATC) system, runs prequalification programmes for medicines, vaccines and diagnostics, and issues guidance across the health spectrum. Its constitution and the 2024 amendments to the International Health Regulations are central to global public health security.

For clinical research and pharmaceutical companies, the WHO matters in several concrete ways. The WHO International Clinical Trials Registry Platform (ICTRP) defines the Trial Registration Data Set and recognises primary registries (including the EU CTIS public portal and ClinicalTrials.gov) whose registration is a condition of publication under ICMJE rules. The WHO Programme for International Drug Monitoring, run with the Uppsala Monitoring Centre, collects pharmacovigilance reports in VigiBase and provides the WHODrug dictionary used to code medications in trials. WHO guidelines on good clinical practice, ethics review, and the 2016 guidance on ethical issues in public health surveillance shape national frameworks, particularly in low- and middle-income countries where trials increasingly recruit.

The WHO has also become an influential voice on health data governance and artificial intelligence. Its 2021 guidance on ethics and governance of AI for health, the 2024 guidance on large multi-modal models, the 2023 global strategy on digital health and its work on data sharing in emergencies set principles (transparency, accountability, inclusiveness, protection of autonomy and privacy) that regulators and funders reference. The WHO is not a data protection regulator and its instruments are not directly binding on companies, but where a sponsor relies on public health grounds under Art. 9(2)(i) or Art. 49(1)(d) GDPR, WHO declarations of emergencies and recommendations often supply the factual basis. As an international organisation, the WHO is also a distinct category of recipient under Chapter V GDPR when personal data is shared with it.