When women of childbearing potential are included in clinical trials, safety precautions must be taken in order to avoid the unintentional exposure of an embryo or fetus to the...
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes...
Clinical trial results are statistically analysed in terms of demographics, efficacy, and safety. Different types of clinical trial may warrant different interpretations of trial results.
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...
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...
