Phase II clinical studies, or proof of concept studies, begin to test the effect of a medicine on the target disease in humans. These studies are usually run as...
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III...
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory...
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and...
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
Statistics play an important role in clinical trials in preventing errors, biases, and false inferrences. This article covers some key statistical concepts, such as hypothesis testing, type 1 and...
Researchers in clinical trials select sample populations from the whole patient population that the trial applies to, as it is not possible to run the clinical trial in the...
Small populations present ethical and practical challenges to organising clinical trials. Small populations include groups with rare diseases or specific sub-types of common diseases, children, and the elderly.
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard...
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