Frequently Asked Questions for patients interested in participating in DELIVER-MS
1. Can I switch medications during the study?
Yes, in the DELIVER-MS study you can switch or stop medications (DMT) after enrolment at any time, in consultation with your clinical team. If you are in the randomized study, you must start a DMT within your randomized group (e.g. high-efficacy, or escalation), but if it turns out not to suit you, or you need to switch you are free to pick any treatment you want.
2. Which MRIs are covered by the study and which do I pay for (USA)?
The DELIVER-MS study pays for the first two MRIs in the study, the Baseline and Month 6. The Baseline MRI occurs very close to when the disease modifying therapy is started. The Month 6 scan occurs around 6 months after the medication was started. The remaining scans (Month 12, Month 24, and Month 36) will be paid for as a part of standard medical care, which means, they are paid for normally, as with any other test you normally get.
3. When will I find out which medication I am going to be put on?
If you are in the randomized study, you will find out which arm you have been randomized to as early as during your first screening visit, after you provide informed consent to take part. This will allow you to discuss with your neurologist which medication within that arm would suit you best. If you are in the observational study, you will probably already know which DMT you will receive at the time you enrol to the study.
4. When will I start my medication?
We do not expect enrolling in the DELIVER-MS trial to alter the time taken for you to start your DMT. Usually this time period is influenced by the need for certain checks (like blood tests), insurance approval (if needed), and the availability of an infusion slot, or the set-up of home-delivery of tablet or injections.
5. Will I still see my neurologist for follow-ups?
Yes, you will continue to see your neurologist for follow-up appointments as you normally would in clinical practice. In those appointments you will receive all the usual care. The study team will try to schedule the research visits around the time you are seeing your neurologist. These research visits occur at 6, 12-, 24- and 36-months after enrolling into DELIVER-MS. During these visits we will do some extra checks on your MS, such as questionnaires and measurements of your dexterity, walking speed and memory. These checks are aimed at informing the research study but you or your neurologist may also find them a useful way of monitoring your condition
6. Will I have any input into the treatment option if I enter the randomized study?
Each arm of the study (Early High Efficacy and Escalation) contains more than one DMT. You may be eligible to receive a number of treatments within one arm. In that case, once you have been randomized, you would be able to discuss, with your neurology provider the most suitable treatment within that arm, depending on your individual circumstances.
7. Will the study take up much of my time and/ or mean time off work?
An important consideration when you agree to take part in any clinical trial, is how much time you will be expected to provide. The DELIVER-MS study has been designed to be pragmatic, and try to fit with your routine appointments so far as possible, in order to minimise any inconvenience. You will find that annual visits (at baseline, 12-, 24-, and 36-months after enrolment) might be longer than a normal clinic appointment. This is because a member of the DELIVER-MS research team will undertake some detailed checks of your vision, arm and hand function, walking-speed, and memory, and also ask you to complete some questionnaires. Some participants find these tests interesting or reassuring, but they are likely to lengthen the duration of your visit. In between the annual clinic visits, you will receive 3-monthly telephone calls to check on your progress, which can be timed to suit your schedule so far as possible. In addition, you will have blood tests and baseline and 6-months, and MRI scans at baseline, 6-, 12-, 24 and 36-months after enrolment, each of which might last up to an hour.
8. What if it costs me money to attend the additional appointments?
In the DELIVER-MS study we try to ensure your research visits coincide with your routine clinic visits. However, we do provide a small stipend to offset any cost of travel to additional visits.
9. Can I stop participating if I feel it’s not for me?
Yes, participation in any research study is completely optional, and participants are free to withdraw at any time. Withdrawal from the DELIVER-MS study would not affect your routine medical care. If you are considering withdrawing from the study, we suggest you discuss this with your research team.
10. What have existing participants said about being in the study?
Below are some quotes from some existing UK participants in DELIVER-MS, who kindly shared their experiences on DELIVER-MS and gave advice for potential participants.
What were the reasons you chose to become involved with the DELIVER-MS study?
“Receiving a diagnosis can make you feel helpless. I wanted to feel I was doing something to make a difference. I did a lot of research myself into treatments and knew I wanted to start on a high efficacy treatment.”
“To help others in the future find the best treatment for this disease.”
“I think it’s important to support research wherever possible! This study is working towards filling a gap in the understanding of MS, so anything I can do to help bridge that gap and help future patients is a must.”
“With the development of new drugs and patients with MS having no cure in sight I felt it was so important to try and support any trials in order to push the understanding of how MS develops when taking new drugs.”
“For me it was very much a case of wanting to make something positive come from my diagnosis. Being able to do something that will eventually help people who find themselves in the same position as me made being told I have MS a little more bearable.”
What has been your experience so far of being involved in the trial?
“It’s been great. The only down time I get is when I come for my visits every 6 months!”
“All very positive so far.”
“Honestly, I have barely noticed I’m on a trial. I think I’ve had an extra MRI and have had a few extra nurse sessions (but those were quite fun). The extra attention actually makes me feel more looked after, and less worried about taking treatments because if anything did go wrong it’s even more likely to be picked up straight away.”
“I feel that being part of the trial has given me a real sense in being part of something for the good, the team are very professional and have excellent communication and interactions with you.”
“Pretty good all told. Everything’s been explained well and is fairly straight forward. I do sometimes forget which type of appointment is due next, but all that’s led to is me getting a check in phone call at 1am when I’d forgotten that it was due while I was on holiday in New Zealand!”