A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from clinical trials on a regular basis and advise the sponsor.
‘Within-trial decisions’ are decisions made once a clinical trial has already begun, for instance if an unexpected problem comes to light. This article looks at two specific kinds of within-trial decisions: Unblinding (code-breaking) and premature termination.
In Phase II trials, the investigational medicinal product is tested for efficacy (and safety). The studies conducted are typically therapeutic exploratory studies which try to discover whether the medicine treats the intended disease or condition.
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest, with the medicine that has been thoroughly and extensively tested in laboratory and animal studies before.
Some groups within the general population of a clinical study may require special study, due to the particular risks, benefits, or treatment requirements associated with them