eConsent solutions offer compelling value, benefiting trial sponsors, sites and patients alike. Despite initial concerns about implementation costs and training, electronic informed consent (eConsent) is gaining traction in clinical trials. 

 

In the evolving landscape of clinical trials, marked by novel designs and a focus on diversity, equity and inclusion, a robust eConsent platform adapts to these changing dynamics. It supports various trial types and engages diverse patient populations globally. In fact, it is a more personalized approach, allowing sponsors to tailor information based on age, culture and learning styles for enhanced comprehension of the trial process.  

 

eConsent minimizes consent-related protocol deviations, establishes an audit-ready trail for data accuracy and simplifies tracking and reporting throughout the trial lifecycle. Experience demonstrates that eConsent platforms save time and money by boosting recruitment rates, streamlining workflows and ensuring data transparency across stakeholders. The results? Accelerated trial timelines, reduced administrative burden and improved data quality.  

 

Enhancing Patient Understanding with Electronic Consent 

Global regulatory guidelines emphasize the need for patients to fully comprehend clinical trial details. The industry is moving beyond a mere signature to a more in-depth process for patients to receive and grasp trial information, the associated risks, benefits, protocols and their role in the process. In this context, informed consent requires participants to: 

Traditional face-to-face interactions in clinical settings have been the norm. The reality is that conventional methods burden patients with complex paperwork. Electronic consent solutions, on the other hand, simplify the process, presenting information in easily digestible digital formats, including audio, video and multimedia elements. By leveraging interactive glossaries, knowledge checks and hyperlinks, complex medical terms are easily explained, thereby ensuring better participant comprehension and informed decision-making in clinical research. 

 

Eliminates Location Barriers 

Modern clinical trials, often decentralized or hybrid, allow flexible participation without frequent site visits. eConsent solutions extend this flexibility by allowing participants to sign consent documents remotely, providing immense convenience and reducing the overall burden of travelling to sites only to sign documents or amendments. This can be especially beneficial for chronically ill patients participating in long running trials that sometimes span across many months and years. 

 

In cases requiring multiple signatures, such as in pediatric trials, eConsent facilitates remote review and signing of Informed Consent Forms (ICFs) for the different signatories without the need for all of them to travel to the clinical site. Prior to signing, signatories can review forms offline, flag sections for clarification and pose questions to site staff. These digital options build confidence and improve overall participant experience, which can directly impact recruitment and retention rates.  

 

By eliminating location barriers and offering flexibility in reviewing and signing consent documents, eConsent promotes a convenient and empowering participant experience.  

 

Benefits for Site Staff 

An eConsent system facilitates enhanced patient education with interactive participant walkthroughs, allowing questions at the participant’s pace, giving site staff more time to resolve doubts and address any residual uncertainties. This valuable time focused on patient wellbeing eventually leads to building deeper trust and confidence between site staff and participants. 

 

eConsent streamlines consent tracking and protocol amendments globally, issuing timely alerts for site staff. Additionally, digital consent, eliminates paper-based challenges such as managing document versions and preventing errors due to missing reconsents, incomplete signatures, signatures on wrong versions or multiple other issues prevalent with paper processes. The system automatically ensures quality and accuracy by reducing errors, protocol deviations and Corrective and Preventive Actions (CAPAs).  

 

Improving Data Transparency and Decreasing Monitoring Time and Cost  

eConsent solutions provide reports and dashboards to visually represent consent related progress. All stakeholders receive tailored reports, enhancing data transparency across different clinical trials. Site staff, trial monitors and sponsors gain valuable, accurate insights based on their roles. 

 

Clinical trial monitors play a crucial role in maintaining compliance and quality throughout the clinical trial. eConsent solutions provide monitors with detailed audits trails along with analytics and reports that help streamline monitoring activities and save time onsite with site staff. This intelligent and focused monitoring eliminates manual reviews of paper forms, saving an average of 15 minutes per ICF. 

 

Streamlining the Consent Process and Minimizing Deviations 

Streamlining the consent process through eConsent not only minimizes deviations but also revolutionizes the efficiency and compliance of obtaining permissions. eConsent solutions provide transparency, safeguard processes, automate workflows and improve quality across patient consents, effectively reducing consent-related deviations. This was clearly evident when an IQVIA study across 100 trials that adopted eConsent showed a 57% reduction in major and critical deviations compared to trials that adopted paper-based consent processes.  

 

By reducing deviations, eConsent saves significant CAPA time and resources and eliminates subsequent delays. Approximately 80% of trials are delayed by at least a month, with potential daily losses reaching around $600,000 (sometimes as high as $8 million). By reducing the risk of delays and improving study quality, implementing eConsent can lead to substantial savings, extending well beyond the cost of these solutions 

 

Thus, eConsent contributes to study completeness, accuracy and reliability as it provides enhanced accuracy and compliance, ultimately contributing to successful therapeutic development. 

 

Encouraging eConsent Adoption by Addressing Reluctance to Change 

Healthcare professionals and site staff are accustomed to paper-based processes, and the lack of a mandate for eConsent in clinical trials contributes to the current reluctance. Despite clear benefits, stakeholders are still slightly hesitant.

 

Concerns range from upfront investment to IT implementation to staff training. To encourage adoption, sponsors must prioritize user-friendly technology that integrates seamlessly into the trial workflow. Selecting a platform and eConsent process aligned with the trial protocol, offering a smooth user experience and providing tools for patient self-sufficiency, is crucial.  

 

Vendor support stands as a pivotal evaluation factor. Sponsors should opt for a provider that offers comprehensive training programs, in-product assistance, tooltips, user guides, alerts and a responsive help desk. Selecting an experienced vendor with a global team ensures the provision of a clear roadmap for effortless integration and adoption. 

 

The Future of eConsent 

eConsent represents more than just a technological advance; it stands as a strategic investment for stakeholders. Patients gain a more accessible and engaging consent experience, while sites benefit from smoother workflows and enhanced data quality. For sponsors, it means expedited timelines, better resource allocation, and heightened data integrity. 

 

Together, these benefits allow for a more efficient, patient-centric and cost-effective approach to clinical research.

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Vinita Navadgi is a technology leader focused on innovation in clinical research and advancement of drugs. With over 25 years of technology expertise, she is passionate about accelerating clinical research and the patient consenting process by leveraging digitally transformative technologies while offering intuitive user experiences.