Everyone who takes part in a clinical trial needs to meet the eligibility criteria, a defined set of rules which state who is suitable to join the trial. The eligibility criteria ensures the trial recruits people who may benefit from the treatment being tested and provides a safeguard so that people who may be at risk if they take part are not recruited.
It’s also worth thinking about the practicalities of joining the trial, for example, there are several clinic visits and Magnetic Resonance Imaging (MRI) scans over a two year period.
A screening process will take place to find out if someone meets the eligibility criteria. Screening is made up of several stages. It is very detailed and some stages of the screening process take place at a clinic visit. Only once the full screening process has taken place will the medical team know whether the trial is suitable for someone and at that point invite them to participate in the MS-SMART trial.
What does the trial involve?
Tablets containing one of the drugs being tested or a dummy pill will be taken every day for 2 years. The effects of treatment will be measured by:
- Assessments at clinic visits (approximately 8 in year 1 and approximately 2 in year 2).
- A number of questionnaires will be completed at certain clinic visits.
- Blood samples will be taken at each clinic visit to monitor safety.
- At some centres, participants may be invited to take part in additional sub-studies (participation in any of the sub-studies is optional).
- Participants will have 3 MRIs during the trial, before treatment starts, at 6 months and at 2 years at the end of the trial.
I’ve registered my details, what happens next?
A research nurse or doctor will be in touch. He or she will ask you some questions about yourself and your medical history. You may then be invited to come to the clinic for a screening visit. Screening and recruitment will take place over a one year period. Once someone is recruited they will take part in the trial for 2 years.