Some reports suggest that as much as 80% of clinical trials globally fail to enroll enough patients on time and that the dropout rate can reach 19%. As a result, developing informed consent experiences that support comprehension of content, set the right expectations, and empower informed decision-making is a smart investment.
It’s hard to reach the right and diverse populations of patients for clinical trials. Once reached, patients receive an explanation of what participating in a trial entails. That allows them to make an informed decision about enrollment. To ensure that people make a voluntary and informed decision about participating in a clinical trial, they are asked to read informed consent material and sign informed consent forms. But informed consent material is frequently several pages long, hard to read, and riddled with medical or scientific jargon. Patients and caregivers report it feels contractual and intimidating.
Lack of good understanding of informed consent by potential participants can lead to either of two outcomes: 1) people don’t feel comfortable with the trial and don’t enroll, or 2) they think they have understood the content, enroll, then drop out as their experience doesn’t match the expectation set by informed consent.
While existing eConsent solutions enable informed consent delivery and may be more convenient for potential participants, many are still not much more than a digitized version of paper forms. They don’t always address comprehension challenges. Good eConsent solutions incorporate simplified and tiered content organization and audio and video components. Still, more can be done.
Leveraging some of the digital elements familiar to patients from their consumer experience — in accordance with ICH-GCP and the Declaration of Helsinki — can go a long way in supporting ease of consumption, comprehension of content, and building trust. Here are a few examples:
- Interactive quizzes to help patients check their understanding of content
- Game-like immersive experiences that simulate selected aspects of clinical trial processes and experience
- Guided experiences, including conversational interfaces, to support the explanation of medical terms and to provide additional context
- A clinical trial companion app serving informed consent updates throughout the trial in an easy-to-follow, seamless experience
A fascinating potential lies in leveraging metaverse to create immersive consenting experiences where multiple sensory modalities are engaged to improve comprehension and drive better retention of information.
Ultimately, rethinking and reinventing the consenting experiences for clinical trials can improve enrollment and retention rates by fostering ease of comprehension and building patient trust. It may also indirectly contribute to improved clinical trial outcomes by increasing access to a more diverse patient population. For those reasons, life sciences organizations should make eConsent reinvention part of their strategy for optimizing clinical trials.
At Globant, we have built engaging experiences for patients, including an AI-based chatbot for patient enrollment in clinical trials that enables access to information about the disease, treatment options, clinical trial options, and the calendar of activities involved in the trial. We have also built a game-like experience to help diagnose patients with clinical depression and a conversational interface to support migraine patients in understanding their condition while providing clinicians with patient-reported outcomes.
Reach out to explore how we can help you build the next generation of your eConsent.