While electronic informed consent (eConsent) has been increasingly leveraged across clinical trials due to its many proven benefits, some trial sponsors have been hesitant to adopt the technology, citing concerns about the perceived costs across the investments of time and training, platform configuration, and deployment. This article discusses the benefits of eConsent solutions and specifically outlines the returns on investment (ROI) gained by implementing eConsent to simplify the trial experience for sites and patients while generating value for sponsors.
Why is eConsent Important?
Clinical trials are becoming increasingly complex through novel trial designs, and hybrid and decentralized protocols, and there is increased focus on improving diversity, equity, and inclusion in clinical research. A robust eConsent platform can be customized to fit all types of trials while engaging a diverse set of patient populations no matter where they are located.
A feature-rich eConsent platform can improve the informed consent process by tailoring information to a variety of age groups, cultures, and learning styles, helping participants better comprehend the trial protocol while keeping them engaged through this complex process. An eConsent platform can also help improve the overall quality by reducing consent-related protocol deviations and creating an audit-ready trail to make tracking and reporting on consents more accurate throughout the trial lifecycle – even when trial amendments occur.
Lastly, experience shows an eConsent platform can save time and money by improving recruitment rates, by making consent-related workflows more efficient, and maintaining data transparency.
Increasing Patient Understanding
Compliance with global regulatory requirements, including health authorities and institutional review boards, demands that patients fully comprehend clinical trial details. This involves more than merely obtaining a signature; it entails providing a comprehensive understanding, covering trial information, risks, benefits, protocols, and participant involvement. Traditionally, this process would occur in a clinical setting conducted by site staff.
Informed consent, at its core, requires participants to:
- Receive sufficient information about the trial.
- Have the opportunity to deliberate, ask questions, and get answers.
- Confirm their full understanding of participation implications.
- Agree to participate and provide ongoing data as needed.
Traditional consent methods inundate patients with complex paperwork, which can be overwhelming in a paper-based system. Electronic systems, however, simplify this process by breaking it down into easily understandable digital content, incorporating audio, video, and multimedia elements and even cartoons for pediatric patients. Presenting medical information through explanatory resources enhances patient comprehension and streamlines consent. Audio and video aids benefit hearing-impaired patients, while visually impaired patients can access audio narration and adjustable font sizes.
Additional resources, like interactive glossaries, knowledge checks, and hyperlinks to explain complex medical terms ensure that patients fully grasp the study's scope and implications.
Distance is No Longer a Barrier
Given the dispersed nature of modern clinical trials that can be decentralized or hybrid – essentially trials that now offer both site visits and remote activity, participants have greater flexibility to participate in research without physically visiting clinical sites at every stage of the trial. eConsent tools support this flexibility, reducing the burden on participants by enabling trial site staff to obtain participant consent remotely through electronic mediums. This is both quick and efficient.
Some consent documents require multiple signatures. For example, in some pediatric trials, multiple signatories such as parents, guardians or legally authorized representatives are required to sign the ICF documents. In such scenarios, eConsent allows each party to remotely read and sign at their own convenience, irrespective of their location. Prior to signing, participants can review forms offline, flag sections that need further clarification or raise questions that need explanation from site staff.
All in all, the participant experience is enhanced by these flexible digital consenting options, which support better recruitment and retention rates for trials.
Benefits for Site Staff
eConsent simplifies consent tracking and protocol amendments for clinical site staff worldwide, streamlining their work across multiple trials by generating timely alerts and calls for action where and when necessary. In addition, eConsent allows site staff to walk the patient through the entire consent process in an interactive format, section by section, allowing the patient to raise questions as they go along while they do it at their own pace. This provides site staff with additional time to focus on unique participant questions and makes the whole experience seamless for all parties. This direct engagement with participants builds trust and fosters greater understanding, adding a certain level of sophistication to the entire experience.
Digital consent enhances patient education and communication while eliminating paper, managing document version controls, minimizing manual tasks, and preventing human errors like missing signatures, signatories, or dates. The electronic system safeguards meticulous accuracy by automatically generating alerts for errors such as missing signatures or incomplete forms. This automatically translates to enhanced quality and compliance by reducing eConsent-related protocol deviations and CAPAs.
Clinical trials sometimes span over many years, across multiple phases that often result in amendments to the initial documentation. Tracking patient consent on amendments can be difficult, time-consuming, and often error-prone. This can be seamlessly managed with eConsent. If patients need to re-consent to any of the amendments during the study, site staff can quickly and clearly outline the change to participants, and secure signatures electronically. All this can be done remotely without setting new time-consuming, arduous, in-person appointments to discuss and sign with wet ink.
Fewer Consent-Related Protocol Deviations
eConsent simplifies the consent process, offering transparency, safeguards, and automated workflows that ensure compliance by reducing consent-related deviations. In a review of nearly 100 trials across IQVIA that used eConsent, consent-related major and critical protocol deviations were reduced by 57% from an average of 14% to only 6% when compared to trials that employed paper consents.
Digitizing this process eliminates manual data entry and paper errors. Completed eConsents instantly populate the study database, creating a secure, verifiable patient consent record that aligns with local regulatory requirements. Analysis of eConsent versus non-eConsent studies revealed 22% fewer major and critical deviations per randomized patient and 53% fewer per-patient visits. Up to 90% of consent-related deviations can be mitigated with eConsent, reducing the need for time-consuming corrective actions.
Addressing major and critical deviations requires significant CAPA time and resources. IQVIA surveys found that using eConsent can save over 224 hours per deviation avoided and an average of 67 minutes per patient. Reducing deviations directly improves study completeness, accuracy, and reliability, positively impacting trial timelines.
Patient recruitment speed, dropouts, and deviations cause study delays, resulting in wasted time and resources. Roughly 80% of trials are delayed by at least a month, with potential daily losses reaching approximately $600,000 (and potentially as high as $8 million). Implementing eConsent can lead to substantial savings, extending well beyond the cost of these solutions.
Improved Randomization Rates
Patient recruitment and retention are both key metrics and challenges for successful clinical trial execution. The number of identified patients to be pre-screened, consented, and eventually randomized significantly falls at each stage. However, in reviewing industry-academic research based on historical data, by employing eConsent, researchers need 25% fewer patients to reach the same completion goals for a trial. To validate this, analysis conducted across IQVIA studies found that while comparing the randomization rates for 55 trials that employed eConsent compared to other trials that used the paper consenting process, there was a 22% increase in randomization rates.
eConsent increases patient retention, engagement, and adherence by enabling patients to have a better understanding of the risks and benefits of trial participation, offering powerful capabilities to optimize study education. We already mentioned multimedia resources, but contextual assistance and accessibility features are also part of this equation, enabling patients to facilitate dialogue with the medical staff and providing capabilities to easily consent from home.
How does this translate to financial impact for sponsors? In traditional settings, approximately 30% of patients drop out of clinical trials, resulting in heavy financial costs. Moreover, on average, it costs $6,533 to recruit one patient to a clinical study, and the average cost of replacing patients in a study is approximately $19,533 per individual. Increasing randomization rates by 22% translates to financial savings.
Decreasing Monitoring Time and Cost
Official clinical trial monitors observe and oversee trials and check compliance levels and progress. An eConsent solution ensures patient consent for correct informed consent form (ICF) documents, tracking signatures before interventional procedures, and maintaining an audit trail.
Monitors can also access documents and detailed analytics remotely, saving time for a more focused monitoring visit. On average, 15 minutes per ICF are saved with eConsent at clinical sites, reducing time and costs for the monitoring and study teams across the full trial.
Improving Data Transparency For All Stakeholders
eConsent systems utilize dashboards and reports to visually display progress in the consent processes. It is not only the ease of data delivery but what happens behind the scenes. Data is aggregated and presented to different stakeholders based on their roles. Site staff receives specific reports for their sites, a trial monitor access information for all sites under their supervision, and sponsors gain insights from globally aggregated data across all sites.
So, Why a Reluctance To Integrate eConsent From Some Stakeholders?
The benefits of eConsent for patients, caregivers, and clinical trial staff strongly advocate for its adoption. However, resistance to widespread adoption persists due to concerns about upfront time investment, IT implementation, staff training, and platform costs.
Healthcare professionals traditionally rely on paper-based patient interactions, making them cautious about altering their routine. Similarly, clinical site staff are accustomed to paper-based processes, reflecting a historical approach in clinical trials. This resistance parallels the shift from handwritten prescriptions to digital systems in healthcare, which initially required acquiring new skills for adopting Electronic Medical Records (EMR) systems for Electronic Health Records (EHR) which were mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act, passed in 2009 as part of the American Recovery and Reinvestment Act (ARRA). In clinical trials, there's no mandate for adopting eConsent, leading some teams to prefer to continue with paper-based consent processes.
Another reason for slow eConsent adoption is that clinical site staff use multiple disparate systems, such as eCOA, eConsent, interactive response technology (IRT), payment, quality management, risk and compliance systems, etc. during the course of the trial. These systems are often not integrated, which requires site staff to manage multiple credentials for logging into each of these systems, each of which has its own workflows and user interfaces; creating a dis-harmonious, broken, and tedious experience overall. There is a need for technology providers to offer unified, integrated solutions that support clinical site workflows with single sign-on capability and seamless experiences throughout the process of the trial.
To promote eConsent adoption among site staff, sponsors must prioritize user-friendly technology that integrates smoothly into their trial workflow. It's crucial to select a platform that aligns with the trial protocol, offers a seamless user experience, and includes tools for patient self-sufficiency in form completion. They should choose an eConsent provider that not only offers robust training programs for site staff but also supports product usage at sites with easily accessible in-product help, tool tips, user guides, and alerts, and a readily available helpdesk.
When considering eConsent options, vendor support should be an essential evaluation criterion. An experienced vendor with a global team will provide customization, training, and help desk support for seamless adoption. After deployment, sponsors should reinforce eConsent benefits during study initiation and offer recognition for exceeding adoption goals to motivate sites. Proof of concept, therefore, is of paramount importance.
That said, once they see the benefits, the general response is that they wished they had employed eConsent years ago.
eConsent is the Future
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 is truly a win-win for sponsors, trial staff, and patients, providing an opportunity for all stakeholders to break from old habits and embrace this new approach that can yield quantifiable benefits. Whether it's decreasing deviations and dropouts or enhancing randomization for increased recruitment, all stakeholders can reap rewards by adopting modern digital consent processes for their research.
Author Details
Vinita Navadgi - Sr. Director, Product & Strategy, Patient Consent, IQVIA Technologies.
Publication Detail
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No. 1Jan/Feb/Mar 2024Pages: 30-32
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