Frequently Asked Questions
Can I register if I/my child does not live in the UK?
This pilot study is only recruiting people with DMD who live in the UK.
How long will the DMD Hub Recruitment Pilot Study run for?
It is planned that the pilot study will last for a period of 12 months.
Will the DMD Hub Recruitment Pilot Study continue past the pilot phase?
We will be conducting a survey of participants and speaking with staff at DMD Hub clinical trial sites during the pilot study, to get feedback on how the study may have benefited the community.
If the pilot study is successful it may continue as an open-ended study. The person/organisation who manages your data on the DMD Hub Central Recruitment Pilot Project may also change if the study continues past its pilot phase.
Once a decision has been made regarding what will happen after the pilot phase of this study, you will be notified.
By registering on the DMD Hub Recruitment Pilot Study will I/my child be recruited to a DMD study that is recruiting in the UK?
There is no guarantee that registering your/your child’s details will mean that you/they will be automatically approached to take part in a research study. Health Care Professionals looking to recruit patients to a clinical trial or another research study will have the opportunity to review the details you have given about yourself/your child and if the trial appears to be suitable for you/them, they may contact you to discuss potential recruitment. If you are contacted regarding a particular trial, you/your child will require to be assessed in greater detail. At this stage it may be clear that other developments in your/your child’s health or details not recorded on the database, mean that the trial is not a suitable one for you/them.
Who is running the DMD Hub Recruitment Pilot Study?
The project is funded by Duchenne UK and is part of the DMD Hub. Launched in 2016, the DMD Hub is a collaboration between the two neuromuscular centres of excellence (The John Walton Muscular Dystrophy Research Centre (Newcastle University) and Great Ormond Street Hospital (London) and Duchenne UK. The DMD Hub is a network of clinical trial sites with dedicated, trained staff which are funded to carry out research studies for DMD. It also uses existing UK clinical trial expertise, to provide a central resource offering advice, guidance and training to sites less experienced in running DMD research studies. Ultimately, the mission of the DMD Hub is to ensure all patients with DMD, both children and adults, have access to clinical research.
Who should I speak to if I or my have any questions about participating/my child participating in the DMD Hub Recruitment Pilot Study?
Before you agree to register yourself/your child on the DMD Hub Central Recruitment Pilot Project, it is important that you understand what is involved and what will be done with the information that you provide. This form contains the answers to the questions that you might have. At the end of the form there are text boxes for you to initial to confirm that you agree to your child participating. If you have any questions after reading this form, please contact the DMD Hub Central Recruitment Pilot Project co-ordinator (email: dmdhub@ncl.ac.uk / Tel: 0191 241 8621) before continuing.
Can I/my child stop participating in the DMD Hub Recruitment Pilot Study at any time?
Joining the DMD Hub Central Recruitment Pilot Project is voluntary. Should you wish to withdraw information about yourself/your child from the study, you will be free to do so at any time without having to provide any explanation. If you wish to withdraw, you should contact the DMD Hub Central Recruitment Pilot Project co-ordinator (email: dmdhub@ncl.ac.uk / Tel: 0191 241 8621). Joining or leaving the study will in no way affect the care you/your child receives for your/their condition and will not preclude them from participating in clinical research and trials.
Is this a one-time registration process?
Yes, you will only have to register once. However, you will be asked to keep your/your child’s information up to date to ensure that it accurately reflects your/their current condition and that we can always contact you. You will be asked at least to log back into your account and update your/your child’s information every 6 months.
How long does it take to register?
It will take you about 20-25 minutes to register and provide us with the required information. You can have a look at the questions that are asked before you register.
How do I know if I have registered successfully?
If you have successfully registered, then you will receive an automated email to welcome you to the DMD Hub Recruitment Pilot Study. This will indicate the email address that you used to register with.
I had to temporarily interrupt my registration. When I wanted to continue, I had to type in my password. Why?
For security reasons you are logged out automatically if you have been idle for two hours, i.e. not clicked on a link or button or typed in any text. After you type in your password as requested, in most cases you should be back on the page you were on before you were logged out. If not, you can click through to the desired page via the navigation bar on the left. If at the time you were automatically logged out you had made changes in a form without clicking the “Save” button, you will have to make these changes again.
I have forgotten my password. What should I do?
If you forget your password, please follow the instructions on the “Forgotten password” page.
How often should my data be updated?
You should update your/your child’s data at least every 6 months and an automated email will be sent to you to remind you to do this. You will have access to your account and so you can in fact log in and review the data stored on you at any time and also make any updates as and when it is necessary.
If you move house, change your email address, or get a new phone number we would ask that you make sure you update this information so that we are always able to contact you.
Where will my data be stored?
The information that you enter will be stored in the DMD Hub Recruitment Pilot Study platform which is supervised by a Steering Committee. Your data will be stored securely and no unauthorized people will be able to gain access to any information about you.
If I agree to take part in a clinical trial or research study at a trial site, but then after I have already started participating a trial site closer to my home opens for recruitment, will I be able to continue on the study at the trial site closer to my home?
If a person is recruited to a clinical trial or research study at a clinical trial site, that is not their non-local site, there is no guarantee that they can move to their local clinical trial site if that site were to open recruitment for the same study/trial. This is a decision that can only be made by the study/trial sponsor.
The DMD Hub Central Recruitment coordination team will try our best to allocate patients who have been identified through the central recruitment database to their closest clinical trial site. However there will always be the possibility that the closest site has already completed recruitment, or is not yet open for recruitment. In this instance, the person/family will need to make the decision on whether to decide to be screened at a different site or wait for the local site to open. The central recruitment database does not play any role in the patient selection for individual trial sites and therefore we will not be able to guarantee that a slot will be kept at a more local site, once a person has been identified as potentially eligible. You should speak with your local clinician if you have any concerns about participating in any clinical trial or research study.
Recruitment in a clinical trial is a competitive process. This means that once the screening and/or recruitment target has been reached nationally or internationally, the trial sponsor will close recruitment, even if a site has already identified additional eligible participants.
Due to regulatory approval processes around clinical trials, recruiting sites are often not activated at the same time (this applies internationally - US sites are often quicker in being set up that sites in the EU, and nationally).
I am already registered on the Great Ormond Street Hospital clinical trial list. Can I also register and participate in the DMD Hub Central Recruitment Pilot Project?
Yes. You can be registered and participate on both. By registering and providing your details on the DMD Hub Central Recruitment Pilot Project website, this will not affect your participation on the Great Ormond Street Hospital clinical trial list and vice versa.
Will all clinical trial sites in the UK use the DMD Hub Central Recruitment Pilot Project to assist with recruitment to DMD studies?
Clinical trial sites in the UK have to request to participate in the DMD Hub Central Recruitment Pilot Project. Each site that participates will use their own recruitment strategy, however each site should aim to screen at least 1 participant from out of area, for every 2 participants screened from their local clinic.