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 firstname.lastname@example.org
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.