Archive Version – this webinar was originally presented on June 15, 2017.
Informed consent is an ethical, mandatory, and fundamental principle of healthcare research. It respects the clinical trial volunteer’s authority to decide whether to participate, reviews their role and responsibilities, and highlights the risks involved. Unfortunately, 18 to 30% of patients enrolling in a trial drop out, with 13% of drop-outs due to patient misunderstanding of consent expectations or related issues.
FDA guidance and patient advocacy groups are driving adoption of electronic consent (eConsent) to make the consenting process more engaging and easier to understand for patients and caregivers. With patient recruitment costs accounting for nearly 1/3 of the total trial cost, there is a financial as well as an ethical reason to make sure patients fully understand the clinical trial process and their vital role. This webinar will review the current informed consent process and how eConsent may help to improve patient comprehension, engagement, and retention.
The presenter from CISCRP will discuss:
- The purpose of informed consent
- Current rules and regulations around the informed consent process
- Data and insights on the number of patients who drop out of studies due to lack of understanding the informed consent
The presenter from DrugDev will discuss how eConsent:
- Ensures patient understanding through multimedia education
- Improves patient retention and reduces recruitment needs
- Provides insight and metrics into how patients read and understand documents
- Improves regulatory compliance
Founder and Board Chair at CISCRP
President of DrugDev Patient Solutions