Blinding is a procedure in which one or more parties in a trial are kept unaware of which treatments participants have received during a clinical trial.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
Paediatric medicine development requires careful planning and decision making. Legislation in the EU mandates that paediatric medicine development should occur early in the medicine development process.
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...
Human medical research is conducted according to strict principles of ethics. These principles have been developed over time, in reaction to various events in human history, and continue to...
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.
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