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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.

E

Electronic clinical outcome assessment (eCOA)

An electronic clinical outcome assessment (eCOA) is the capture of a clinical outcome assessment through an electronic device rather than on paper. It covers electronic patient-reported outcomes (ePRO), electronic clinician-reported outcomes (eClinRO), electronic observer-reported outcomes (eObsRO) and electronic performance outcomes (ePerfO), captured on provisioned tablets or handhelds, on participants' own smartphones (bring your own device, BYOD), on web portals or through wearables and sensors.

eCOA improves data completeness and timestamps entries, which regulators value for diary-type data. It requires that the electronic version of a validated instrument is shown to be equivalent to the original (ISPOR guidance), that the system meets 21 CFR Part 11 and EMA computerised-systems expectations, and that participants receive training and support. eCOA is a building block of decentralised clinical trials.

The data captured is health data reported directly by patients, often about mood, pain, sexual function or daily activities. Devices generate additional data (device identifiers, IP addresses, location if enabled, usage patterns) that must be minimised under data protection by default. In BYOD models the participant's phone becomes part of the trial infrastructure, raising questions about app permissions, push notifications that may reveal trial participation, and what happens to local data on withdrawal. The eCOA vendor is a processor and typically hosts data outside the site's country, so the DPIA must address transfers and encryption in transit and at rest.

Is eCOA simply a paper questionnaire displayed on a phone?

No. Electronic delivery introduces administration, usability and system considerations that can affect data collection. Check that the instrument remains suitable for the intended population and mode of use, and test reminders, timing, access and support arrangements. Participants should understand how to use the tool and whom to contact when it fails.