The patient enrollment process in clinical trials can be tedious and quite cumbersome — overwhelming patients with pages of documents outlining potential risks, benefits, and consequences of their proposed medical treatments, and troubling them with long, complex, and difficult to understand forms. Patients often miss the opportunity for a dialogue around education and understanding with their clinical site staff, which can lead to poor engagement and ultimately, increased dropout rates.
With growing support from international regulatory agencies, recent FDA guidance documents, industry groups like Transcelerate Biopharma, and large central Institutional Review Board (IRBs), the clinical research and biobanking industries are rapidly adopting eConsent as an alternative to paper.
In the webinar Roche and Medidata will explore the benefits of eConsent:
- Provide patients clear and easy-to-understand clinical trial information so that they are truly informed when making a decision to participate
- Improve patient compliance by offering sites the tools to get insight into patient’s understanding and reduce complex and time-consuming explanations, paperwork and quality risks
- Reduce inspection findings and establish submission considerations for Health Authorities and Ethics Committees to improve review/approval process
- Enable process efficiencies, reduce corrective actions for audit/inspection consent findings, improve patient recruitment process and reduce dropout rates