VISION-DMD

Designed to ensure a timely & cost-effective drug development for Duchenne muscular dystrophy

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  • The Project
    • Summary
    • Project Objectives
    • Project Consortium
    • Contact us
  • About DMD
    • What is DMD?
    • Living with Duchenne
    • Current treatment options
    • Duchenne boy’s stories
    • DMD Community
    • Standards of Care for Duchenne muscular dystrophy
  • Study Information
    • What is a clinical study?
    • Phase 2a clinical trial information
    • Phase 2a preliminary study results
    • Phase 2b clinical trial information
    • Phase 2b Preliminary Results
    • MRI – Magnetic Resonance Imaging
  • Drug Development
    • Development of Vamorolone
    • Vamorolone development programme
  • Innovations
    • Return of patient data
    • Bone Health Outcomes
    • Biomarkers
    • Vamorolone study APP for boys
    • Patient Group Funders
    • What is Venture Philanthropy?
  • Resources
    • Relevant publications
      • VISION-DMD INFORMATION APP OVERVIEW
      • VISION-DMD Thought paper
    • VISION-DMD Workshops
      • Workshop series: Standards of Care
      • Workshop series: Biomarkers and Imaging
    • Webinars and presentations
    • Press Releases
    • VISION-DMD project Interviews
      • Collaborating for progress on rare diseases: an interview with Dr. Daria Julkowska, Scientific Coordinator of the European Joint Program on Rare Diseases.
      • Returning vamorolone study data to patient caregivers. What, when and how clinical trial data is returned to study participants. An interview with Dr. Laurie Conklin
      • An Interview with Andrea D’Alessandro – Clinical research project manager at TRiNDS
      • Interview with Jana Haberlová – Paediatric Neurologist at University Hospital Motol
      • Interview with Alex Johnson: a parent and patient foundation funder
    • VISION-DMD Project Newsletters
      • VISION-DMD newsletter sign up
    • VISION-DMD Poster presentations
    • Our privacy policy
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Return of patient data

From talking to parents and patient foundations, it is apparent that families are interested in having access to their child’s study data. Clinical studies are often ‘blinded’ to preserve the integrity and validity of the study results. This means parents don’t know if their child actually received the study drug, a comparator drug or a placebo. They also don’t know how their child responded to the experimental drug compared with other participants in the study.

Reveragen Biopharma wanted to address this and successfully applied for a bioethics-related research study grant to develop an approach to return the clinical study data to participants from the vamorolone clinical studies.

To enable return of study data, patient’s parents or caregivers need to self-refer themselves to the centralized study coordinator, Suzanne Gaglianone (ReveraGen). Suzanne will explain the study, and if the parent wishes to participate, they will be sent an email with consent forms to review and sign. This consent will allow for identification of the patient in the study database, and delivery of the child’s data. Once the consent forms are signed and returned, Suzanne collects information to facilitate the data return including the postal address, parent name and email address, child’s date of birth and study site, to locate the child’s data from a secure, password-protected database. The child’s study data are downloaded onto an encrypted USB drive and mailed to the parent; a password needed to unlock the encryption is emailed separately.

The returned data will include the patient clinical study data (including study arm assignment eg vamorolone, comparator or placebo), and comparison data to other participants in the trial via an anonymous aggregate data report.

As the VISION DMD clinical studies are international and conducted in several languages, a interpreter is available for telephone calls to Suzanne and all consent forms, information and surveys are translated into the native language of the participant.

For more information or to request the return of data please contact [email protected]

WHITE PAPER: RETURNING INDIVIDUAL CLINICAL TRIAL DATA BACK TO PARTICIPANTS

The VISION-DMD team have produced a white paper addressing the ethical and technical challenges of returning meaningful individual clinical trial results to trial participants. Click here for the white paper.

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This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 667078.

To find out more about the project contact us at [email protected]

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