Table 1

Types of clinical data available for research studies

CharacteristicsObservational dataClinical trial
RWD-EHRProspective longitudinal cohort study or registry
DefinitionData from EHR relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sourcesNon-interventional clinical study, prospectively collecting data on a group of patients with a particular disease or symptomPatients assigned to one or more interventions to evaluate its impact on healthcare outcomes, for example, randomised controlled trial
Patient populationBroad, encompassing medical system or population areaRestricted by study participationRestricted eligibility criteria, often excluding elderly and people with comorbidities
Data typesHigh dimensionalHigh no, limited by research design and variables for collection decided a prioriVariables/outcomes for collection decided a priori
Data collected as part of patient care from both patients and physiciansStructured data collection and questionnaires
Data presenceSparce, noisyStructured, same data collected on all participantsHighly structured and often with detailed clinical data
Missingness not at randomFairly completeLow missingness
ScaleLarge, thousands to millionsModest, hundreds to thousandsSmall, tens to thousands
GeneralisabilityStrong 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.