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.

Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.

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.

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.

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.