All participants in a clinical trial are assessed to ensure they are eligible to take part. This ensures that the treatments under investigation are tested on a group of similar people. It also helps exclude patients for whom the treatments may pose a risk. The eligibility criteria for the COBALT Trial can be viewed here.  

Patients who might be able to take part are given information on the trial and given opportunities to ask questions. After the local trial team have answered all of their questions, patients who wish to continue sign a consent form. By signing the consent form they are showing that they understand what they have to do and that they consent to take part in the trial and undergo further assessments to make sure that they fit the necessary criteria to be a participant.

During the trial, the local trial team (including doctors, nurses and other health care professionals) will monitor participants progress, and they will undergo assessments specific to the clinical trial, in addition to those that the participants will have at their usual clinic visits. Participants will be asked to fill out questionnaires and provide additional information about how they feel and how they think the trial medication is working.  

Participants are free to stop their participation in the trial and withdraw their consent at any point. Participants can also choose to stop taking the trial medication but continue with the trial assessments.