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. 2022 Sep 23;82(3):306–311. doi: 10.1136/ard-2022-222626

Table 1.

Types of clinical data available for research studies

Characteristics Observational data Clinical trial
RWD-EHR Prospective longitudinal cohort study or registry
Definition Data from EHR relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources Non-interventional clinical study, prospectively collecting data on a group of patients with a particular disease or symptom Patients assigned to one or more interventions to evaluate its impact on healthcare outcomes, for example, randomised controlled trial
Patient population Broad, encompassing medical system or population area Restricted by study participation Restricted eligibility criteria, often excluding elderly and people with comorbidities
Data types High dimensional High no, limited by research design and variables for collection decided a priori Variables/outcomes for collection decided a priori
Data collected as part of patient care from both patients and physicians Structured data collection and questionnaires
Data presence Sparce, noisy Structured, same data collected on all participants Highly structured and often with detailed clinical data
Missingness not at random Fairly complete Low missingness
Scale Large, thousands to millions Modest, hundreds to thousands Small, tens to thousands
Generalisability Strong local structure can restrict generalisability
Incorporating real-life noise into the analyses improves applicability to real life settings
Easily replicable in similar designed cohorts
Generalisability restricted by patient selection and data not always directly implementable to real life settings.
The more restrained the patient selection the less generalisable

EHR, electronic health record; RWD, real-world data.