The clinical trials landscape continues to evolve and with it, an exponential growth in the adoption of electronic informed consent (eConsent) solutions. These solutions deliver a myriad of benefits for trial sponsors, sites and patients. However, there is still some reluctance to adopt these solutions due to perceived costs associated with implementation and training.
The Importance of eConsent
Clinical trials are evolving with novel designs, hybrid and decentralized protocols and an increased focus on diversity, equity and inclusion. An adaptive eConsent platform supports these diverse trials, reaching patients globally while also tailoring information to individual needs, including age, culture and learning styles. Through this process, eConsent enhances patient comprehension and engagement during the entire trial process, minimizes protocol deviations and maintains an audit-ready trail, ensuring data accuracy, simplifying tracking and reporting.
Experience shows that eConsent platforms save time and money by boosting recruitment rates, streamlining workflows and ensuring data transparency. This results in accelerated trial timelines, reduced administrative burden and enhanced data quality.
eConsent for Patient Understanding
Adherence to global regulatory guidelines requires patients to fully comprehend clinical trial details. Traditionally, trials have relied on face-to-face interactions in clinical settings for this purpose.
The essence of informed consent mandates that participants receive adequate information about the trial so they can carefully consider their participation, allowing them ask questions and receive clear answers. Patients need to confirm their understanding of the implications of participation as well as agree to the trial and provide ongoing data when required.
Conventional, paper-based methods can overwhelm patients with lengthy, complex documents to read. Considering this, electronic consent simplifies the process with easily digestible digital formats (e.g., audio, video and multimedia elements) geared to engage different demographics and enhance comprehension.
Interactive glossaries, knowledge checks and hyperlinks that explain complex medical terms, are also part of eConsent, and they ensure patients fully grasp the study’s scope and risks and what is expected during their participation in the clinical research.
Location Barriers Minimized Through eConsent
The dispersed nature of modern clinical trials, often incorporating decentralized or hybrid designs, offers participants greater flexibility without the need to physically visit clinical sites at every stage of the trial. eConsent tools further enable trial site staff to obtain participant consents remotely, streamlining the process and reducing the burden on participants.
In certain cases, consent documents require multiple signatures. For instance, pediatric trials may require signatures from parents, guardians or legally authorized representatives. eConsent facilitates this process by allowing each party to review and sign the Informed Consent Form (ICF) remotely, at their own convenience, regardless of their location. Prior to signing, participants can review the forms offline, flag what needs clarification or raise questions. These digital education and consenting options contribute to an improved participant experience, ultimately boosting recruitment and retention rates for trials.
By eliminating location barriers and providing participants with the flexibility to review and sign consent documents at their own pace, eConsent promotes a more convenient and empowering experience for the patient.
Site Staff Benefiting from Digitization
eConsent simplifies consent tracking and protocol amendments for clinical site staff worldwide, streamlining their work by generating timely alerts and calls for action when necessary. eConsent allows them to walk the patient through the entire consenting process in an interactive format, allowing teams to focus on participant questions, leading to a better experience for patients.
Digital consent improves site-to-patient education and communication, reduces paperwork, manages document versions and streamlines manual tasks. The electronic system ensures accuracy by automatically flagging missing signatures or incomplete forms. Quality and compliance are enhanced by minimizing protocol deviations and corrective and preventive actions.
Moreover, direct engagement with participants builds trust and fosters greater understanding, adding a certain level of sophistication to the entire experience.
Efficient Consent Processes and Reduced Protocol Deviations
eConsent significantly streamlines the consent process, ensuring transparency, compliance, and a notable decrease in deviations. A study conducted by IQVIA on nearly 100 trails utilizing eConsent revealed a remarkable 57% reduction in major and critical protocol deviations. This reduction decreased from an average of 14% with paper consents to just 6% with eConsent.
Digitizing the process eliminates manual data entry and human errors. Completed eConsents are securely stored in the study database, meeting regulatory requirements. Addressing major deviations with eConsent can save over 224 hours per deviation and an average of 67 minutes per patient, positively impacting study completeness, accuracy and reliability and contributing to shorter trial timelines.
Patient recruitment speed, dropouts and deviations can cause study delays, resulting in wasted time and resources. Approximately 80% of trials are delayed by at least a month, with potential daily losses reaching around $600,000 (and potentially 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.
The Benefits in Time, Costs and Data Transparency
Clinical trial monitors are crucial for ensuring the compliance and progress of a study. eConsent solutions provide several benefits that can streamline the monitoring process and reduce costs.
Since an eConsent solution tracks signatures and maintains an audit trail, it eliminates the need for monitors to manually review paper-based consent forms, saving an average of 15 minutes per ICF.
eConsent solutions utilize dashboards and reports to visually display progress in the consent processes. Data is aggregated and presented to different stakeholders based on their roles. Site staff receive specific reports for their sites, trial monitors access information for all sites under their supervision and sponsors gain insights from globally aggregated data across all sites. Meaningful data with actionable insights can be shared smoothly across all stakeholders.
The Reluctance to Integrate eConsent and Promoting eConsent Adoption
Unlike Electronic Medical Records (EMRs) and Electronic Health Records (EHRs), which were mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, eConsent is not a requisite for clinical trials. This has led some sites to continue with paper-based processes and this is why – despite evident advantages – stakeholders are still hesitant to adopt eConsent. In fact, concerns about IT implementation time, staff training and platform costs are among the top challenges for adoption. The reality is that clinical site staff are accustomed to paper-based patient interactions, making them cautious about altering their routine.
Clinical site staff often use multiple disparate systems, such as eCOA, eConsent, IRT, payment, quality management and risk and compliance systems, during the course of a trial. These systems are not necessarily integrated, which requires managing multiple credentials and navigating different workflows and user interfaces, creating a disjointed and tedious experience. This adds to the resistance of implementing new technologies.
To encourage adoption, trial sponsors should prioritize user-friendly technologies that seamlessly integrate into the trial workflow. The chosen platform should align with the trial protocol, provide a smooth user experience and offer tools for patient self-sufficiency. Selecting an eConsent provider with robust training programs, in-product help, user guides, alerts and a responsive help desk is crucial. Beyond, post-deployment, sponsors should reinforce eConsent advantages during study initiation and recognize sites exceeding adoption goals.
What is next for eConsent?
eConsent delivers value to all stakeholders within a clinical trial, and with adoption increasing, they are set to become a permanent part of clinical research. Promoting the adoption of this technology among sites today will boost compliance, streamline consent data management and offer participants a high-quality, engaging experience right from the beginning of the trial.
Investing in an eConsent solution proves beneficial for sponsors, trial staff, and patients alike. From reducing deviations and dropouts to improving randomization, stakeholders stand to benefit by adopting modern digital consent processes.
About Vinita Navadgi
Vinita Navadgi is the Sr. Director, Product & Strategy, Patient Consent at IQVIA Technologies focused on innovation in clinical research and the 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.