Returning individual clinical trial data back to patients – VISION-DMD project update
11th March 2021
After taking part in a clinical trial, patients and their families have a right to see the data collected about them during the trial. However, they are often unable to due to several challenges around returning trial data to participants.
Drug development company ReveraGen BioPharma have been working to address these challenges as part of VISION-DMD – a project which is trialling a drug called Vamorolone, an alternative to steroids to treat Duchenne muscular dystrophy (DMD).
During clinical trials for DMD treatments, a doctor will take measurements from the patient at regular intervals, such as how far they can walk in six minutes. This is to see if the treatment they are taking is having a positive impact or not. Families taking part in trials are currently facing barriers to receiving this data. These include issues around confidentiality and data protection, uncertainty over how to explain the data to the patient and family, how to transport this data into a patient’s medical record, and ensuring the data is accurate.
ReveraGen BioPharma investigated these barriers during clinical trials of Vamorolone, and came up with four key solutions:
- Having a single, central ethics committee review the return of results from worldwide trials
- Addressing confidentiality issues by allowing a single person to access the patient data and communicate it to families (a ‘firewall’)
- Educating families about the project and encourage them to request their data.
- Surveying participating families and their physicians to understand the types and format of the data they want, and their perceptions of it.
Duchenne UK have been long term supporters of the VISION-DMD programme and invested over £700,000 with our partner, Joining Jack, in the phase one trial of Vamorolone. We are very pleased to see the success of this project and hope that this framework will be taken up in the future by other companies.
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