DMD Hub Central Recruitment Pilot Project

Information for participants

Information for participants

The DMD Hub Central Recruitment Database is a national resource for children and adults with Duchenne Muscular Dystrophy who are interested in participating in clinical research studies in the disease area. The online database collects information about people with DMD via a questionnaire that is either completed by the person with DMD, or their parent or guardian. Participants will be asked to consent and then answer a series of questions aiming to support the evaluation of eligibility for clinical research studies. The questions have been developed by key opinion leaders in the DMD field, including clinicians, academics, patients, and parents of boys with DMD. 

All information we receive will be treated confidentially. Information entered in the DMD Hub CRD online platform will be stored on a secure server located in the UK. Only members of the DMD Hub CRD team will be given specific permission and will be allowed to look at this information. If we publish any research or other documents based on information from the database, this will not identify participants.

The DMD Hub Central Recruitment Database (CRD) will build upon the existing infrastructure already developed as part of the DMD Hub Central Recruitment Pilot Project. It will be expanded to ensure an even more equitable access to research studies for patients, by a more inclusive approach allowing clinicians to discuss the CRD and enrol patients during routine clinical appointments; serve as a resource for industry, academics and clinical trials site to inform clinical trial feasibility and recruitment target; to be able to answer research questions around clinical trial in DMD.

Main Aims/Objectives of the CRD:

Be an effective tool in facilitating participation in research studies for people living with DMD regardless of their geographical location.

Provide fairer and equitable access to clinical research studies for patients with DMD in the UK.

Integrate clinical research opportunities in routine clinical care of all patients with DMD in the UK.

Serve as a resource for industry, academics as well as clinical trial sites to assess clinical research study feasibility, support setting and define realistic recruitment target and strategies.

Address research questions regarding interest in clinical trial participation and how this evolves over time.

 

The database is aimed at people with a confirmed diagnosis of Duchenne muscular dystrophy (DMD) and who are interested in participating in research studies in DMD that are taking place in the UK. Children (under 16 years) must be registered by their parent or guardian. The database is only open to people who currently reside in the UK.

We ask for your personal details, such as name, address, date of birth, NHS number and where you are treated for your DMD. We also ask about your genetic diagnosis, motor function, wheelchair use, medication taken and preferences for participation in research studies (including type of study and travel preferences). You will be asked to update this information every six months.

The DMD Hub Central Recruitment Database is looked after by Professor Michela Guglieri at Newcastle University.

About the DMD Hub Central Recruitment Database

Here you will find out more information about why we have a database and how your data will be used.

What is the DMD Hub Central Recruitment Database?

The DMD Hub Central Recruitment Database collects information about people with DMD who are interested in participating in research studies. The objective of the database is to facilitate fair and equitable access to clinical research, by supporting trial sites in identifying potentially eligible participants to take part in DMD research studies in the UK.

The CRD is also actively assisting clinical trial sites in the UK with recruitment to DMD clinical research studies which otherwise would not have been able to meet recruitment targets using their local clinic lists of patients, and/or would have taken longer to complete recruitment.

How do I benefit from registering?

Although one of the main objectives of the database is to facilitate recruitment in research studies for people living with Duchenne muscular dystrophy regardless of their geographical location, participation will not guarantee that somebody will be recruited (or approached to be recruited) in a study. Recruitment in a research study will depend on national recruitment targets, eligibility criteria and will remain a responsibility of the Principal Investigator for the study at each clinical trial site.

Although the main objective of the CRD is to facilitate recruitment in research studies for people living with DMD regardless of their geographical location, registration into the recruitment database will not guarantee that they will be recruited (or even be approached to be recruited) in a clinical trial. 

Recruitment in a research study will depend on national and site-specific recruitment targets, eligibility criteria and will remain a responsibility of the Principal Investigator (PI) for the study at each clinical trial site.

If a site is looking for potential eligible participants for a specific research study, a Health Care Professional at the site will be able to contact the DMD Hub CRD project team to identify potentially eligible participants from the DMD Hub CRD, based on the information available on the database. Potential study participants will be identified by the DMD Hub project team who with consent in place, will be allowed to share the patient information and contact details with Health Care Professionals at clinical trial sites. Again, with consent in place the Health Care Professional at the trial site will be able to contact the patient’s local neuromuscular specialist centre and/or the individual to assess eligibility against the study specific inclusion and exclusion criteria, discuss the specific trial and potential recruitment. 

All people identified as potentially eligible for a particular research study through the CRD and the initial screening with the local neuromuscular specialist, will still need to be assessed as part of the study specific screening requirements to confirm eligibility.

Each DMD Hub site will aim to use the national recruitment process for enrolling out of area participants into clinical trials. 

I want to be involved in a research study (e.g., clinical trial or natural history study). If I register, is this guaranteed?

There is no guarantee that registering your details will result in you being approached to take part in a research study. Health Care Professionals looking to recruit people to a study will have the opportunity to review the details you have given and if the study appears to be suitable for you, they may contact you to discuss potential recruitment. All people contacted regarding a particular study will then be assessed in greater detail and at this stage it may be clear that other developments in your health or details not recorded on the DMD Hub Central Recruitment Database mean that the study is not a suitable one for you.

Who can register?

People with a confirmed diagnosis of Duchenne muscular dystrophy (DMD) and who are interested in participating in research studies in DMD that are taking place in the UK. Children (under 16 years) must be registered by their parent or guardian. The database is only open to people who live in the UK.

How do you register?

Registration involves completing an online questionnaire; you can view the questions you will be asked.

Are my details safe?

All information we receive from you will be treated confidentially. The information that you enter into The DMD Hub Central Recruitment Database about yourself will be stored on a secure server located in the UK. Only members of the DMD Hub team will be given specific permission and will be allowed to look at this information. If we publish any research or other documents based on information collected in the database, this will not identify you by name.

A key aspect of the DMD Hub CRD is that we are able to share participant information (including personal information and information about a participant’s condition) with health care professionals and other qualified personnel at clinical trial sites within the UK, and that they are able to feedback participant information to the CRD, in order to help with recruitment to DMD studies.  To do this we will verify the trial sites requesting to utilise the DMD Hub CRD and then use a secure encrypted file sharing service with trial sites to share information.  You will have the opportunity to give your permission for sharing your data in this way on the participant consent form.

De-identified data may be shared with third parties (e.g. pharmaceutical companies, academic institutions, charities) who have been approved by the DMD Hub CRD Steering Committee, but no identifiable data will be shared with any organisations outside the one listed above.  Duchenne UK, as the patient organisation supporting the CRD, may be granted access to participant contact information (name and contact information) for community outreach and communications purposes. You will be asked whether you are willing to share your contact details with Duchenne UK. This will not impact your enrolment in the CRD.

Your data will not be made available to employers, government organisations, insurance companies or educational institutions, nor to other members of your family.

Where can you find out more about how your information is used?

For more information about how we use your information consult the main study Patient Information Sheet, or the URL:

www.hra.nhs.uk/information-about-patients/

If you would like more information about how we manage personal data more generally, including your rights under law, and the contact details of Newcastle University’s Data Protection Officer please see our website: http://www.ncl.ac.uk/data.protection/

Who looks after my data?

The DMD Hub Central Recruitment Database is looked after by Professor Michela Guglieri at Newcastle University. The DMD Hub Central Recruitment Database is governed by a Steering Committee. Your data will be stored securely, and no unauthorised persons will be able to gain access to any information about you or your child.

Who has allowed this data to be collected?

The Faculty of Medical Sciences at Newcastle University have reviewed and agreed to sponsor this project.

This project has also been reviewed and approved by Derby Research Ethics Committee.

Participant information sheets