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Table 1 Regulatory attributes of clinical trials, compassionate use, emergency use and off-label use

From: Current regulatory approaches for accessing potential COVID-19 therapies

 Clinical trialsCompassionate useEmergency useOff-label use
Regulatory approvalNo
ScopeClinical researchClinical practiceClinical practiceClinical practice
Informed consentNoN/Aa
Target populationNo
Safety reportsN/A a
Ethical board approvalNoNo
Control groupNoNoNo
Gathering evidenceEfficacy, SafetySafetySafetyN/Aa
Risk-benefit assessmentGroupGroupGroupOn a case-by-case basis
  1. aThis table used unified regulatory characteristics of the EU and the US. Instead of “yes” we used the” tick symbol”. Also, when a unified criteria was not met we used the not applicable (N/A) choice