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Adopting eConsent provides patients with adequate information on studies they may choose to participate in, and thus improving the rate of patient satisfaction and retention.
Informed consent is a fundamental principle of healthcare research. It explains to the patient the goal of the study, their role as a subject of research, the risks involved, and what they should expect if they decide to participate. According to FDA guidance, sponsors and physicians must provide patients with adequate information to make an informed decision, facilitate patient comprehension and provide adequate opportunity for the subject to ask questions.
Historically the focus has been on getting the consent signed rather than on making sure the patient understands the information in the informed consent form (ICF). The Industry has not done an excellent job of informing patients of what participation in a trial means, as evidenced by the high dropout rate. In a recent CISCRP survey 35% of patients who dropped out of a study reported that they felt the consent document was difficult to understand.
Paper consent often is a weighty document, sometimes over 30 pages long, and full of medical terms and legalese most patients don’t understand. Additional studies suggest that patients who are presented with eConsent significantly improve understanding of the trial, and this is correlated with a higher observed patient retention rate. Keeping patients engaged and informed can have a dramatic impact on their overall experience.
Electronic informed consent, or eConsent, improves the consent process based on several proven educational methods. It incorporates combinations of video and audio narration, features illustrated popup glossary terms, organizes ideas in digestible “chunks” (progressive disclosure), enables patients to highlight areas they have questions about for discussions with sites, and provides opportunities for interactive quizzes to reinforce ideas and test for comprehension along the way.
eConsent tracks the patient review process so physicians/coordinators can identify where patients are having trouble in the document and what needs to be discussed in more detail. This stimulates more meaningful conversations between the physician and patient and can help reduce the patient’s anxiety and reluctance. eConsent can be easily adapted for hearing or vision impairment, children, language differences or other special needs. For example, the font size of the text can be easily adjusted, or a video can be created to optimally engage various demographic profiles.
In its 2016 Annual Global Site Survey, DrugDev queried 418 sites worldwide on site-facing technology adoption. 72% of sites surveyed had no experience with eConsent, yet at least 50% agreed eConsent would decrease site burden and be easier to use than the paper version by offering improved version control, a better dialog with the patients, and better patient comprehension.
In the survey, 77% of the sites reported they are not using eConsent simply because they have not been asked by the sponsor. It is clear sites are open to using the technology but need more education and a better understanding of the process as they would with any new technology or system.
So why aren’t more sponsors and CROs using eConsent? Do they fear sites won’t like it? That it may take too much time? Or is it because they don’t want to introduce yet another system and yet another login?
Like any new technology, the time required to switch to an eConsent program isn’t trivial, but the long-term rewards far outweigh this initial effort. While many sites still use multiple EDC systems that require multiple log-ins, the industry is seeing unified clinical trial systems that streamline clinical operations and reduce the logins required to run a trial.
It wasn’t that long ago when EDC was introduced and naysayers felt it would never be adopted. Now the majority of sites are using EDC to capture and share trial data. Adoption of eConsent can and will occur if sponsors and CROs want faster enrollment and improved patient satisfaction and retention. eConsent manages the patient consent process using technology and devices patients already use in their daily lives. It enables real-time tracking and data management, and helps patients and investigators make fully informed, thoughtful and appropriate decisions for their treatment.
Eric Delente, President of Patient Engagement, DrugDev. firstname.lastname@example.org