Author: Tina Caruana, Subject Matter Expert of eClinical Solutions at Medrio
Communicating scientific information accurately and clearly isn’t easy. But getting this right is critical to the success of current and future clinical trials. Recruitment and retention have always been challenging, and these difficulties have only increased in recent years as a growing focus on rare diseases and targeted subpopulations make it more and more difficult to find matches for trial inclusion criteria. Patients who understand the risks and benefits associated with participation and exactly what will be expected of them during a trial are less likely to drop out. This can reduce the cost and length of the study, benefitting sponsors, while also contributing to the advancement of science.
An electronic consent (eConsent) form incorporating interactive features like embedded quizzes, multimedia components and live links to additional information about the trial can transform the informed consent process into something educational, engaging and valuable for everyone involved. eConsent can boost retention rates, improve participants’ experiences, and increase their knowledge about their contributions to the research.
Being Clear Can Be Complicated
By nature, scientific discourse involves complexity. Trial sponsors have long been legally and ethically obligated to ensure that research participants have all the information they need to make an informed and autonomous decision about participating in research. This means sponsors must communicate scientific information in thorough, clear, engaging and, above all, understandable ways. It’s no easy task.
Informed consent has typically been collected using lengthy, detailed paper forms, averaging between 15-20 pages (forms longer than 35 pages are not unusual). And in therapeutic areas like oncology, where trial protocols tend to be more complex, it’s especially difficult to communicate the information succinctly and in ways that make it easy to read, remember and understand.
As a result, many prospective participants may tend to skim over the forms quickly. Reading a 19-page document written at a seventh- or eighth-grade reading level would take most people between 35 and 60 minutes—more time than many participants are willing or able to spend reviewing pre-trial paperwork. Plus, informed consent forms are often packed with scientific jargon or legal-ese, making them tough to comprehend. The consequence is that patients often don’t know the true risks associated with participating in the trial and don’t understand precisely what is expected of them. These study participants are more likely to drop out.
This lack of true comprehension also raises ethical issues since the imperative to obtain informed consent has long been enshrined in legal and ethical frameworks governing voluntary participation in clinical research. If a patient doesn’t fully understand what they’ve agreed to, arguably, they haven’t really agreed.
Recent changes to the HHS Common Rule suggest increasing regulatory scrutiny is on the horizon. The Food and Drug Administration (FDA) has also stepped in to address challenges in the informed consent process.
Trial sponsors and CROs must find better ways of communicating. What’s needed is a modern approach that unlocks technology’s full potential to educate, engage and inform trial participants so they can fully understand what’s involved in the research.
Informed Consent: An Aid or Obstacle to Retention?
When informed consent documents are presented once—early in the enrollment process—that suggests that informed consent is a task that must be completed only once, at a single point in time. In fact, informed consent is better thought of as an ongoing process that continues to provide patients with relevant information so they can make knowledge-based decisions about the risks, benefits and requirements involved in participating in the research.
Regulatory requirements stipulate that, if written, the information must be provided at a reading level appropriate for its audience. The paper forms traditionally used to gather informed consent often fail to meet this benchmark. While the average American reads at a seventh- or eighth-grade level, as many as 19% of U.S. adults have reached only the lowest levels of literacy as defined by the National Center for Education Statistics (NCES) proficiency scale. This creates the potential for a large mismatch between the literacy level informed consent forms require for comprehension and what would-be trial participants have attained.
This problem is compounded by the fact that trial participants who are differently abled, have medical conditions that impede reading and/or comprehension, or are members of underserved populations may have even greater difficulties understanding informed consent forms.
In addition, trial participants come from a variety of backgrounds and, by nature, have a broad array of different learning styles. Some may, in fact, be served well by paper documents, while others would comprehend better if they were offered audio, video or multimedia content.
Failing to address these challenges poses a major obstacle to retention. Research indicates that participants who drop out of studies are more than twice as likely to say that the study didn’t meet their expectations. They’re also nearly twice as likely to report that the informed consent form they were given was difficult to understand. In contrast, prospective participants with a complete and thorough understanding of what will be expected of them are less likely to find site visits stressful. Often, they’ll have better emotional experiences throughout the study.
How eConsent Is Changing the Game for Patients and Sponsors
A recent, large-scale systematic review has demonstrated that using electronic informed consent forms can potentially improve comprehension and participant experience in biomedical research. However, not all electronic informed consent forms are the same. Some are simply paper documents presented in a PDF format that allows for digital signature.
A true, full-featured eConsent solution can do much more. Consent form materials can be made accessible online, giving participants ample time to review and digest them (instead of forcing them to make a quick decision in the presence of the site manager, study coordinator or PI). Prospective participants can easily share—and discuss—the information with family and friends.
What’s more, new versions of eConsent forms can readily be uploaded if trial protocols shift. Managing document versioning through a compliance-friendly electronic system is in keeping with the fact that informed consent is a process—not a single, point-in-time requirement.
eConsent can include interactive features like mini-quizzes that reinforce and measure comprehension, giving site managers and sponsors evidence of participant understanding. It can also include multimedia elements such as audio and video to support various learning styles. And the site can feature links to additional information about the research or definitions of terminology for participants interested in learning more.
Tomorrow’s informed consent processes will be digital and data-driven. With the ability to measure participant understanding interactively, sponsors will no longer need to guess whether or not they’ve communicated clearly and successfully. Implementing eConsent is a critical step that will bring sponsors closer to the future of clinical research, better-supporting innovations like decentralized and virtual trials, which are rapidly becoming mainstream.