Delivering an eConsent solution to support patients, sites, and study teams
As the move towards the adoption of digital trials accelerates, sponsors need to be confident they are making the right technology choices. This means thinking beyond patient-facing applications and considering the end-to-end clinical trial process to streamline study execution and management for sites and study teams.
eConsent solutions are no exception. Sponsors must seek a solution that meets the needs of all stakeholders – patients, sites, and study teams – to ensure successful implementation and achieve the efficiencies that digitized trials have the potential to deliver.
Here are four ways that an end-to-end eConsent solution can streamline the set-up, completion, and review of consent for sites and study teams while providing a simple, engaging experience for patients.
Improve the patient experience
In the move to make clinical trials more patient-centric, eConsent provides several opportunities to improve the consenting experience for patients and help provide a complete understanding of a study, especially as clinical research protocols become more complex.
Paper consent forms are often long, intimidating documents. Moving to an electronic format means information can be displayed in a more digestible format, breaking information up into manageable sections and enabling the inclusion of images and videos. This improves comprehension, ensures that each participant fully understands what they are signing up for, and allows them to easily access the information later if required.
An appointment to provide consent often involves a separate visit to the site for patients, so they can feel under pressure to make a quick decision to avoid another visit. eConsent opens up the opportunity to provide patients with the relevant documentation ahead of time, giving patients time to consider participation, ask questions, and talk to their support network at home before choosing a trial.
However, the delivery platform for eConsent needs to be considered alongside other patient-facing technologies. In the post-pandemic world, patients are bombarded with multiple apps for different aspects of decentralized trials. No matter how intuitive or engaging the individual solution, moving between different apps for different actions adds technical complexity and can be confusing.
As we strive to make patient participation in clinical trials easier, we must consider the full picture and make access as simple as possible across patient solutions, and within them.
Reduce site burden
The benefits of eConsent for patients are clear, but all too often, the practical implications of introducing additional technologies to sites are not top-of-mind. For example, using a different patient consent solution for every trial isn’t optimal; sites can be using up to 40-50 different systems across their studies at any one time. Every system includes distinct processes and requirements, and the slightest deviation leads to compliance risk.
This is a significant challenge for sites as research teams struggle to implement standard procedures for consenting when there is so much variation across systems. Therefore, sponsors and CROs must bear this in mind when making selections. Suppose a site has already selected a technology and embedded it in their processes. Ideally, it should be possible for them to continue using it to remove administrative burden and allow them to focus on supporting their patients.
By introducing an eConsent solution that can be used across many studies, sites can benefit from a significant reduction in burdensome tasks such as manually checking all consent forms for completion, errors, and appropriate signatures, printing, scanning, and filing paper documents, even paying for storage. This improves trial oversight and ensures compliance for sponsors while allowing sites to spend more time with patients.
“Over the years, we have seen how paper complicates execution, reduces efficiency, and provides limited accountability. Using paper, paying for storage, and hiring additional staff to manually check all the consent forms for completion, errors, and appropriate signatures dramatically increased our economic burden.”
Charles Sydnor, CCRA, ACRP-CP, project manager, Crofoot
Real-time access to information
Sites, sponsors, and CROs need to have complete visibility and transparency into the consent process. In paper consent processes, ensuring each patient is on the most current version of consent is challenging, requiring multiple monitor visits to physically inspect the consent documents.
By moving to an electronic process sponsors can ensure that sites are operating with the latest version of consent and that updates are distributed automatically. This is particularly valuable for gaining re-consent. For example, if there is a protocol amendment between a patient’s scheduled site visits, re-consent can be sought in the interim so that the patient remains fully consented prior to the next visit. Being able to update consent remotely simplifies the process for sites, particularly as patients can be at different stages in the study, and many months may pass before the next site visit is due.
Additionally, sites report that sharing documents across systems and with partners has allowed them to work more systematically and cost- effectively. It also allows sponsors and CROs to quickly validate information, ensure all activity is compliant, and handle audits more efficiently.
Streamline creation and review
Last, but certainly not least, is the speed and efficiency with which eConsent can be implemented, updated, and reviewed.
There are many different requirements for consent across different regions and types of studies. eConsent solutions can provide the necessary flexibility to meet the needs of in-person or remote consenting processes, and specific study requirements such as adding witness signatures for pediatric studies.
Paper-based consent solutions require the use of email and manual handoffs between sponsors and sites, which is resource intensive and increases the chances of the erroneous use of outdated informed consent form (ICF) versions. By utilizing connected systems eConsent significantly reduces the administrative burden of ICF creation and ensures sites always operate with the latest version.
In fact, management of consent versions is a major pain factor for both sites and sponsors. Approval of protocol amendments is usually staggered region by region and needs close management to ensure new versions are distributed appropriately. eConsent systems can manage the process automatically, ensuring updates are distributed to the right sites at the right time, and enabling sites to track which patients have re-consented and which have not.
Additionally, the introduction of preview emulators enables sponsors to easily share true-to-life versions of the consent documents with ethics boards. This gives better insight into the patient experience and makes it easier to review and approve ICFs than providing hard copies of screenshots.
For more information on how to deliver an eConsent solution to support patients, sites, and study teams visit Veeva eConsent.