3 ms·
Pretty sure uncontrolled trials are common at the latest stages of drug development. It's called a single-arm trial. Source: I once participated in a phase III
by astura 7y ago
Pretty sure uncontrolled trials are common at the latest stages of drug development. It's called a single-arm trial.
Source: I once participated in a phase III open-label single-arm trial.
- s1artibartfast 7y agoThey exist, but are usually not sufficient to support a drug or vaccine approval. The standard is two well controlled studies, but additional open label trials may be used to address specific health authority concerns. If you are interested, you can look up the other trials the drug may have gone through.