Frequently Asked Questions
Can I register if I/my child does not live in the UK?
The database is only available to people with DMD who live in the UK.
By registering on the DMD Hub Recruitment Database 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 Database?
The CRD is part of the DMD Hub which launched in 2016 as a partnership between the John Walton Muscular Dystrophy Research Centre at Newcastle University and Duchenne UK; the DMD Hub team is responsible for the coordination of the CRD.
Launched in November 2014, the John Walton Muscular Dystrophy Research Centre (JWMDRC) brings together and consolidates Newcastle’s distinguished, international and world-leading record in research and care for neuromuscular diseases. Our team is based at the Institute of Translational and Clinical Research, Newcastle University and its associated hospitals work together towards the development and application of genomic and translational medicine to improve the health outcomes of people living with neuromuscular diseases. The team in Newcastle are experienced in the set-up and coordination of neuromuscular research databases across a range of rare disease areas.
Duchenne UK was founded by two parents, Alex Johnson and Emily Reuben, after their sons were diagnosed with DMD. They joined together to form Duchenne UK in 2016. As the leading DMD medical research charity in the UK, they aim to end Duchenne and its devastating impact. They connect scientists, the pharmaceutical industry, the NHS and families to advance and accelerate medical research, while bringing everyone affected by DMD the care and support they need.
Who should I speak to if I or my have any questions about participating/my child participating in the DMD Hub Recruitment Database?
Before you agree to register yourself/your child on the DMD Hub Central Recruitment Database, 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 confirm that you agree to your child participating. If you have any questions after reading this form, please contact the DMD Hub Central Recruitment Database Project Manager (email: dmdhub@ncl.ac.uk / Tel: 0191 241 8621) before continuing.
Can I/my child stop participating in the DMD Hub Recruitment Database at any time?
Joining the DMD Hub Central Recruitment Database is voluntary. Should you wish to withdraw information about yourself/your child, you will be free to do so at any time without having to provide justification. If you wish to withdraw, you should contact the DMD Hub Central Recruitment Database Project Manager (email: dmdhub@ncl.ac.uk / Tel: 0191 241 8621).
Joining or leaving the database 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 Database. 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?
If you do not update/verify your data in the CRD for 2 years, your data will not be used for any activity (including referrals to trial sites for potential inclusion in clinical trials).
You will be contacted directly by the CRD in the following circumstances:
To obtain your genetic report.
Every 6 months with a request to confirm data on the database is up to date or to update if necessary.
At specific occasions when additional information is required to assess eligibility for a clinical trial, not already included in the dataset.
Otherwise, the CRD will not contact you on a regular basis. If you are selected for a specific clinical research study, the clinical staff at the clinical trial site, rather than the CRD staff, will contact you to invite you for screening.
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.
Potential Risks of Taking Part
There are no direct risks involved in participating in the DMD Hub CRD. However, you should be aware that there is no guarantee that registering on the DMD Hub CRD means you will be approached to take part in any clinical research study. Participants are selected according to eligibility criteria set by the company running the study, and randomly selected from a pool of eligible patients.
Registration is always voluntary. You have the right to withdraw their consent to participate at any time, and any information provided will be deleted. To do so, contact: dmdhub@newcastle.ac.uk
Where will my data be stored?
The information that you enter will be stored in the DMD Hub Recruitment Database 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 to 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 Database?
Yes. You can be registered and participate on both. Registering and providing your details on the DMD Hub Central Recruitment Database website will not affect your participation on the Great Ormond Street Hospital clinical trial list and vice versa.