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...
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
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.
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...
The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give...
