Clinical trial and clinical research are experiencing a transformation marked by a surge in the adoption of electronic informed consent (econsent) solutions. Vinita Navadgi, Sr. Director of Product & Strategy for Patient Consent at IQVIA Technologies, emphasizes the numerous advantages these solutions bring to trial sponsors, sites, and patients. Despite the evident benefits, there is still some resistance due to perceived implementation and training costs.
The Significance of Econsent
The landscape of clinical trials is evolving with novel designs, decentralized protocols, and an increased emphasis on diversity and inclusion. Adaptive econsent platforms support these diverse trials, reaching global patients and tailoring information to individual needs, enhancing comprehension, and engagement. econsent streamlines workflows, boosts recruitment rates, and ensures data accuracy, leading to accelerated trial timelines and reduced administrative burdens.
Enhancing Patient Understanding through Econsent
Traditional face-to-face interactions for informed consent are being replaced by electronic formats, providing easily digestible digital content tailored to different demographics. Features like interactive glossaries, knowledge checks, and multimedia elements improve patient comprehension and understanding of the trial scope and risks. By eliminating location barriers, econsent allows remote consent, contributing to an improved participant experience.
Empowering Site Staff through Digitization
Econsent simplifies consent tracking, protocol amendments, and patient interaction, reducing paperwork and streamlining manual tasks for clinical site staff. The digital system ensures accuracy, compliance, and a better experience for participants, fostering trust and understanding. Engagement with participants builds a sophisticated level of interaction.
Efficiency in Consent Processes and Reduced Deviations
IQVIA’s study reveals a remarkable 57% reduction in major and critical protocol deviations with econsent. The digitized process eliminates manual data entry and human errors, saving significant time and resources. By reducing the risk of delays and improving study quality, Econsent contributes to substantial savings.
Benefits in Time, Costs, and Data Transparency
Econsent solutions streamline monitoring processes, reducing costs and saving time for clinical trial monitors. Dashboards and reports provide visual progress updates, ensuring meaningful data with actionable insights is shared across stakeholders.
Overcoming Reluctance and Promoting Adoption
Unlike EMRs and EHRs, Econsent is not mandatory, leading to reluctance among sites. Concerns about implementation time, staff training, and platform costs hinder adoption. User-friendly technologies that seamlessly integrate into trial workflows are crucial to encourage adoption. Selecting a provider with robust training programs and ongoing support is essential.
The Future of Econsent
With increasing adoption, eConsent is poised to become a permanent fixture in clinical research. Promoting adoption today ensures compliance, streamlined consent data management, and a high-quality, engaging experience for participants from the trial’s outset.
About Vinita Navadgi
Vinita Navadgi, Sr. Director of Product & Strategy, Patient Consent at IQVIA Technologies, brings over 25 years of technology expertise to drive innovation in clinical research and drug advancement. Passionate about leveraging transformative technologies for accelerating clinical research, she focuses on providing intuitive user experiences.