VISION-DMD published a white paper on how to return individual clinical trial results back to patients. It focuses on addressing the ethical and technical challenges, using the vamorolone clinical trial experience.
In short:
- Often, individual patient data is not returned to the participants, even when this is requested.
- ReveraGen received a grant to develop an approach providing patient study data directly to participant families
- The white paper highlights several challenges and barriers, proposing a framework to return clinical trial data
- So far, 15 families have initiated the return of individual results
“Patients participate in a clinical trial to generate new knowledge to advance drug and technology development. During a clinical trial, data on individuals is collected to generate aggregated information to support the study objectives.” Says Dr. Conklin, Medical and Regulatory Director, ReveraGen BioPharma. “Often, this individual patient data will not be returned to the participants, even when this is requested.”
Read the paper here: White Paper: Returning Individual Clinical Trial Results Back To Patients.