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...
‘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...
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...
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,...
There are several types of clinical trial designs: randomised or non-randomised controlled trials, single or double blinded trials, and superiority or non-inferiority trials.
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
Compensation in clinical trials is not always a standard but may be offered to participants according to different models and in line with the respective legislation and regulations.
Epidemiology is the study of the various factors influencing the occurrence, distribution, or prevention and control of disease, injury, and other health-related events in a defined human population.
When performing a critical reading of clinical study results, the reader should take relevant information into account from the best available sources and should consider questions about the reliability,...
