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 trials | Compassionate use | Emergency use | Off-label use | |
|---|---|---|---|---|
Regulatory approval | ✓ | ✓ | ✓ | No |
Scope | Clinical research | Clinical practice | Clinical practice | Clinical practice |
Informed consent | ✓ | ✓ | No | N/Aa |
Target population | ✓ | ✓ | ✓ | No |
Safety reports | ✓ | ✓ | ✓ | N/A a |
Ethical board approval | ✓ | ✓ | No | No |
Control group | ✓ | No | No | No |
Gathering evidence | Efficacy, Safety | Safety | Safety | N/Aa |
Risk-benefit assessment | Group | Group | Group | On a case-by-case basis |