Table 2

Applications of randomised registry trials

SuitableNot suitable
  • Existing drug–new use

  • One-time interventions

  • Follow-up limited to data collected in routine clinical care

  • Open-label but blinded endpoints

  • Risk-based monitoring

  • Simple source data verification

  • External validity (ie, results can be generalised to the population of interest) is of high interest/priority

  • First-in-man

  • Novel devices

  • Novel drugs

  • Mechanistic or complex substudies

  • Extensive follow-up/repeat visits needed

  • Subjective endpoints

  • Internal validity (ie, ability to attribute observed effects to a treatment or study arm rather than to confounding) is of high interest/priority

  • Complex hypotheses or endpoints

  • Complete monitoring needed

  • Countries without adequate health informatics systems

  • Areas with inadequate systems to ensure personal data protection