• Home
• Responsibility
• Our values and policies
• Clinical trials
• Clinical trial protocols

Clinical trial protocols

A detailed protocol is developed for each clinical trial. This sets out the purpose of the research, and explains how the trial will be conducted and the results analysed. The protocol must be reviewed and approved by an ethics committee before the trial can begin.

Protocols are prepared in accordance with the internationally accepted Good Clinical Practices Guidelines developed by the International Conference on Harmonisation.

The protocol tells investigators how to conduct the research. It sets out criteria for including and excluding people in the trial. It includes details such as the dosage and duration of treatment and the number of participants required to ensure the results will be valid. The protocol also defines the measurements that will be used to judge whether the new drug is safe and effective, and describes the type and frequency of patient evaluations, and appropriate procedures if participants want to withdraw from the study.

Back to top