Informed or electronic consent “eConsent” is of significant interest to clinical research professionals at present as sponsors and sites continue to grapple with cumbersome paper-based consent forms while looking for more cost efficient solutions.  To date few Australian sponsors have taken advantage of informed consent software and are continuing to use the existing paper based systems.  Understanding what is entailed in making the transition to eConsent can aid sponsors in evaluating the benefits of moving from one of the last paper-based bastions left in clinical research to eConsent.  eConsent is more than simply converting the existing paper based consent documents into an electronic format.

We all agree that the paper based consent process is daunting to potential participants who are faced with up to 30 pages of documentation to read.  Participants often choose not to enter the trial or study, or they enrol and then withdraw later on because of poor language skills and/or low health literacy.  eConsent is a highly effective way of communicating with participants in a language they will understand whilst increasing trial recruitment and retention.

The key drivers for implementing eConsent include increased recruitment, reduced participant attrition, increased regulatory compliance and the enablement of remote monitoring of the eConsent process, not to mention significant cost savings.  International experience shows that an effective eConsent system provides participants with an interactive experience that educates and confirms the participant’s knowledge of the trial process. 

In order to transition from a paper-based environment to eConsent it is necessary to reinterpret the eConsent process into an educational and participant focused experience from start to finish.  Industry best practice uses multimedia content delivery to enhance the participant’s understanding of the trial process as it increases the likelihood of the participant joining and remaining in the trial, with lower attrition for non-clinical reasons.   A combination of audio visuals, animations or diagrams describing the consent process along with an intuitive interface that guide the participant through the consent process and is a positive reinforcement of the participant’s knowledge of the trial’s aims, objectives and processes. The system then collects the participant’s legal consent to enter the trial using an eSignature.

The availability of digital technology is rapidly encouraging users to take advantage of technology that can collect and store a variety of personal health information, including electronic medical and health records, and participants can record their own outcomes after a medical intervention.  This technology has rapidly changed healthcare delivery including the use of eConsent in clinical trials.  There are a number of well-designed eConsent platforms in the market that provide participants, their families and caregivers with the ability to consume consent material in their own time and on their own device and enrolment can take place anywhere anytime.  FDA and other regulators around the world have published guidelines and are very supportive of eConsent.  IRB’s love eConsent because it fulfils the requirements of FDA while engaging and fully informing potential participants about the trial.

A large number of Phase I, II & III trials have implemented eConsent and it has benefited all of the stakeholders. Sponsors and service providers can streamline the process based around collecting participant informed consent.  Sites are able to monitor the status of all participants.  eConsent can reduce the time needed to consent a participant and meet the trial’s recruiting targets, and ensure the participant is fully informed and engaged in the trial.  The eConsent process can be integrated with other clinical trial and management systems to seamlessly induct participants into the clinical trial or study.  Participants have a greater understanding of the trial and their involvement and once consented are much more likely to remain in the trial.

Industry figures published in Feb 2019 based on the analysis of trials across the world, indicated that on average 69% of identified participants are pre-screened out of the trial.  While this may appear high, it is dependent upon the therapeutic area, disease and the trial’s acceptance criteria. In this scenario 58% did not consent, 32% are screened out and 18% failed to complete the trial, leaving just 7% of identified participants completing the trial.  Based on these figures a trial requiring 200 subjects would need to identify 2,758 potential participants.  If an eConsent environment could increase the number of consented patients by 10%, the trial would only need to find 2226 potential participants achieving a saving of 19%.

eConsent has the potential to provide a significant benefit to sponsors running trials or studies.  Industry experience demonstrates that eConsent will reduce trials costs for trials with more than 50 subjects.  There are many case histories describing realisable benefits of eConsent.  eConsent can be seamlessly integrated into the trial process and has the potential to improve trial recruitment, retention, significantly reduce trial costs and enhance patient involvement and knowledge.  Best practice indicates that all sponsors should be considering eConsent technology.

Evado Clinical

Evado Clinical offers a cloud EDC, eConsent and PROM services for clinical trials and studies. Evado eConsent can also provided as a stand-alone solution.