The study population is the group of individuals in a study. In a clinical trial, the inclusion and exclusion criteria describe who will and will not be included, thus defining the characteristics of the study 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, methodology, results, discussion, significance, and conclusions of the study.
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.