Non-clinical toxicity studies investigate the safety profile of a medicine. Candidate compounds must undergo many different toxicity studies before they are first administered in clinical trials or receive marketing...
There are several forms of data collection in clinical trials, including electronic methods and Patient Reported Outcomes (PROs). All forms of data collection must adhere to Good Clinical Practice...
After they are published, clinical study results should be critically reviewed and assessed for such things as reliability, bias, significance, and fit with existing literature.
A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric...
Phase I trials are usually the first studies of a medicine conducted in humans – known as ‘first-in-human’ (also known as first-in-man) trials. They are typically human pharmacology studiest,...
A Data Safety Monitoring Board (DSMB) is a group of independent individuals, external to the trial, who are experts in relevant areas. They review the accumulated data from clinical...
The European Patients’ Academy (EUPATI) guidance document on patient involvement in regulatory processes aims to support the integration of patient involvement across the entire process.
