Biologic medicines, or protein-based medicines such as insulin, are designed to interact with specific targets in the patient’s body. A more targeted mechanism of action should lead to a...
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...
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.
Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the...
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...
During the non-clinical safety testing step of the medicines discovery and development process, molecules undergo safety testing in animal subjects in order to determine whether or not they are...
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...
