Expert: eConsent Eases Enrollment, Improves Trial Oversight
A large-scale shift toward using electronic consent in clinical trials — rather than older, clunkier paper versions — could improve understanding of the process, speed up enrollment and enhance trial monitoring, but sponsors and sites must be willing to adapt to the changes, an expert says.
“What I see is some technology learning and an adoption curve,” says Susan Brink, executive vice president of eConsent products and services at Enforme Interactive.
For clinical researchers, that also includes bringing online systems in sync with quickly evolving regulatory guidelines. Most recent is the FDA’s draft guidance on informed consent, issued in March (CTA, March).
Though much of the compliance burden will be shouldered by software providers, sponsors will need to ensure standards are up to par. Researchers should identify system constraints and which sites are open to e-consent, Brink says. To meet guidelines, systems must have robust documentation of SOPs and all necessary forms, without sacrificing HIPAA-mandated patient privacy. Regular internal and external audits will be required.
Sponsors and CROs should ensure ongoing, high-level review of all documents, data and analytics collected, Brink says. The electronic consent system needs to be able to securely hold all necessary documents and have tight controls over who can access what information. Time stamps and version control on all actions are also integral features of the new consent style. The consent record must be stored on the system server in PDF form.
When implementing a system, researchers should work closely with their IRB to find out whether it has guidelines in place for e-consent and what they entail. If the online system is new to the board, the trial sponsor should schedule a meeting and education session to go over expectations, requirements, comfort level and who will handle oversight.
Formal staff training is key to making the transition smooth, Brink adds.
Brink sees the enrollment-related regulatory environment, which now allows digitally rendered signatures, as encouraging. “It’s not so much that you put it into a 30-page document; it’s how people understand it and access it that is the most important,” Brink says.
The trial expert points to trends driving eConsent, including a U.S. literacy rate that has adults reading at less than an 8th-grade level, making it difficult for patients to grasp trial nuances and decide on participation.
Electronic consent forms contain tiered sections, rather than page numbers, allowing for more in-depth, media-based education for the patient, Brink notes. Forms may include videos, graphics and audio — translated into languages other than English — that inform the potential enrolled not only about the drug and the trial details, but also about their illness and potential side effects to watch out for.
This will make it easier to tap into harder-to-reach populations, such as illiterates or non-English speakers, accelerating enrollment, says Brink, noting patients who understand their role and the purpose of the trial are more likely to follow through and attend necessary appointments. A web tutorial-style presentation could also be parlayed into child-specific consent forms that use simpler language, comic books or illustrations.
The idea of a tailored form that helps patients be more involved in their own consent is gaining momentum, Brink says. “There is much more emphasis on freedom to say… ‘What do you see that you need?’”
Using eConsent also enables questions to be flagged electronically and addressed by professionals after the form has been completed, allowing for smoother completion.
“This is a different type of system and workflow, so things take time,” Brink says. However, if done correctly, eConsent can improve connectedness between multiple forms bolstering oversight of the process, she adds. — Victoria Pelham
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