Are trials safe?

Clinical trial safety

The medicines we study are all tested thoroughly before we give them to volunteers. All our trials are reviewed by an independent Ethics Committee, who ensure that our clinical trials are ethical, and that the information we give you is as full as possible, including any known side effects. A UK Government agency reviews them to make sure they are as safe as possible.

Regardless of whether you take over-the-counter medicines or study medicines, some people will experience side effects. For example, medicines to treat cold and flu symptoms may cause drowsiness.  These side effects are usually minor and wear off without causing any harm.  Serious side effects are extremely rare, as the study medicine is given in much smaller doses than have been shown to be safe in animals.  Remember, there will always be a doctor available, and medical staff to advise you about any side effects.

Different drugs are eliminated from the body at different rates. But most drugs are undetectable in the blood by 3 months after the last dose – that’s why you must leave a 3-month gap between studies.

Trial approval

First, we have to submit the trial to the MHRA and an Ethics Committee. An Ethics Committee is an independent group of medical people and members of the public. They ensure that the protocol (study plan and all procedures) is right and proper, and that the information leaflet and the consent form, and adverts we intend to use are clear and fair. They ensure that subject’s right, safety and comfort are respected.

Once the trial has been approved, we advertise details in the newspapers and on websites. We also inform volunteers who call us or who register through our website of the trial details.

Read our Clinical Frequently Asked Questions (FAQs) for more information.