Informed consent is a critical element of any clinical trial, as it starts the process that leads to a patient's participation in a trial. An informed consent form (ICF) is written by sponsors and delivered to patients to provide them with all the information they need about the study to make an informed decision around their participation. Traditionally done with paper-and-pen, an effective ICF is clear, concise, and straightforward, while covering all of the required elements defined by regulatory bodies, such as Good Clinical Practice (GCP) as defined in ICH E6(R2). Unfortunately, many ICFs are not well-written, use overly scientific language, and are overly complex, which can confuse and potentially alienate a potential participant. This blog examines ways to improve this important communication process using clear language and the latest technology.
ICFs: A challenge and opportunity
An ICF that’s written without considering the comprehension of potential participants can have an outsized impact on a clinical trial, with the potential to negatively affect trial recruitment and retention. On the other hand, when used properly the ICF is a great opportunity to ensure participant knowledge and kick off a trusted relationship between researcher and participant. The importance of this trust simply can’t be overstated, especially when it comes to recruiting historically underserved and underrepresented populations.
Research clearly shows that ICFs should be friendly, straightforward, and conversational—written at or below an 8th-grade reading level, with a readability score of more than 50. Sponsors should also consider the needs of diverse audiences, and create different versions for different target populations.
Although each audience is different, there are some basic principles to keep in mind when creating ICFs:
- Provide summaries, use repetition, and leverage different types of phrasing:
- When discussing complex subjects, repeat the information in different ways and provide high-level summaries at the beginning or end of sections.
- Keep it brief and straightforward:
- State exactly what needs to be stated in the most direct way possible.
- Research linguistic preferences:
- Understanding different cultures’ verbal tendencies will greatly benefit your ability to clearly communicate.
In addition, people’s attention spans are short, so the more you can provide in the shortest amount of time possible, the better. ICFs, therefore, should not be any longer than necessary, and it’s a good idea to consider using alternative methods to deliver the information. The use of videos, for example, provides a user-friendly way to deliver information to participants in an engaging and informative manner.
Patient-centric design and visual technology
As mentioned above, it’s critical to consider what a patient needs when reviewing an ICF. Will they comprehend it, or get bogged down in academic language and miss vital information?
In other words, will the patient come away better informed, or merely frustrated?
These are important questions to ask, and the best policy is to ask patients directly. That’s why we recommend using a patient advisory council to test content during the design phase.
In addition, why not borrow from strategies we already know work well in the consumer world, such as delivering information via video? In fact, 90% of online shoppers consider video helpful in the buying process, so it’s worth exploring videos as an example of what eConsent makes possible.
Visual content in videos, such as graphical elements like infographics, provide a natural avenue for tiered information and are far easier to process and understand than dense walls of text. Videos also provide the opportunity to pause the presentation for quick knowledge checks, include glossaries to define relevant language, offer web links, use a voice over for audio-focused learners, and much more.
How Medable can help
When seeking out a technology solution for ICFs in your next clinical trial, ensure it incorporates patient input with visual learning. For example, Medable TeleConsent is a patient-centric solution, and is informed by Medable’s Patient Advisory Council, a nationwide network of advocates who advise Medable and customers on ways to improve patient access, experience, and outcomes.