Phase 1 units for clinical trials with medicines
The first phase in a clinical trials programme for medicines is called Phase 1. If it is the first time a new medicine is given to a human being, the study is called a First-in-Human trial.
A trial centre that carries out First-in-Human studies shall be fit for purpose in terms of the design of the premises, the competency of the personnel and internal procedures for safety monitoring and emergency medical care. These factors are usually assessed at an inspection by the Medical Products Agency. The purpose of the inspection is to ensure that:
- the rights, safety and well-being of the study participants are safeguarded
- the clinical investigator and other personnel have the qualifications and experience of carrying out clinical medicine trials at an early stage, and also training in GCP and intensive care
- the premises are suitable and that there is access to intensive care
- there are procedures for, and that measures have been taken to minimise the risk of First-in-Human studies.
If an individual First-in-Human trial is to be carried out at a clinic, the inspection shall be carried out during or in close conjunction with the application for authorisation from the Medical Products Agency. No study participants may be included in the study until the inspection has been completed and concluded. The inspectors shall determine whether the trial site is suitable for carrying out the First-in-Human trial according to applicable regulations.
Following the systems inspection, trial sites that regularly carry out First-in-Human studies can be assessed as suitable for carrying out First-in-Human studies according to the applicable regulations, and they will then be inspected every three years.
Apart from carrying out medicine trials, Phase 1 units may also carry out studies involving medical devices or foods.
For further information about inspection of Phase 1 units, please contact the Medical Products Agency’s inspection unit.