Since 2018, Medable has employed a network of patients and caregivers whose job is to help improve the clinical trial experience for everyone. Their work is designed to help facilitate equitable, inclusive, and diverse clinical trials. They are called the Patient Caregiver Network (PCN).
For the last 12 months, various PCN members attended over 25 industry conferences, webinars, and events. Their goal was to help facilitate new ideas, education, and growth with Medable and our products. They also sought to reflect on what our industry currently does right for patients and caregivers, and what still needs more improvement.
Both Medable and the PCN know the industry shares in our mission in helping make clinical trials more equitable, inclusive, and diverse. Thus, you can find the PCN’s reflections from 2022 below.
Decentralized Clinical Trials are Here to Stay, and Patients are Pleased
By now, it’s well known that decentralized and digital trials are here to stay. According to GlobalData, the volume of decentralized and hybrid clinical trials rose 28% from 2021 to 2022.
This is fantastic news from a patient perspective. Both patients and caregivers see reductions in burden with decentralized clinical trials, as they reduce travel, geographical restrictions, and allow people with busy schedules and/or family obligations the chance to participate.
Perhaps the most important feature brought about by digital and decentralized from a patient perspective is telehealth. The ability to check in with a physician live without leaving where I am is paramount to our ability to participate. Not only is the reduction in visits important, but it’s nice to be able to create a face-to-face rapport remotely, and get real clarity to questions we may have.
Overall, the PCN is pleased with the direction trials are headed. In the past, several of our members' kids missed up to one-third of their school year in order to travel to sites. Thus, we’re pleased that those participants in the 1300 estimated DCTs that took place last year didn’t have to encounter this roadblock to care.
For Participants and Their Caregivers, the Devil is in the Details
In general, digital and decentralized solutions provide the same wealth of information, reduction in burden, and options to caregivers as they do participants. This means that any increase in decentralization is a win for caregivers. However, of the 25 conferences attended, only three of them, or 12% directly covered the topic of caregivers.
One of the big takeaways from the conferences, as well as from the PCN, is providing information early, upfront, and when possible, with options. In the beginning, some PCN members had concerns that participants and caregivers may become overburdened with information. However, both the industry and the PCN have seen that people prefer to have time to sit with the information and learn it in their own manner.
In fact, essential information is a must-have with today’s increasingly educated patients and caregivers in order for them to decide on whether they choose to participate in a given trial. This essential information, at minimum, must include the purpose of the trial, potential risk factors, and information about the study drug itself.
Outside of essential information, additional details such as learning about the benefits of the drug, being informed of the overall progress of research, and having flexibility in scheduling study visits are information that participants and their caregivers prefer to have as soon as possible.
Technological Change Brings Changes in Participant Preferences
As technology has changed, the ways in which participants wish to learn information have also changed.
In 2022, the industry undertook a lot of effort in trying to uncover the nuances and specific challenges facing clinical trial participants utilizing technology. Today, our industry is rightfully thinking of how age, race, and geographic location directly impact participants' ability to successfully access the technology, understand it, and feel fully supported.
What information is presented, when it’s presented, and how it is presented are important to sponsors, sites, participants, and caregivers alike. This means that sponsors must be prepared to offer participants a few different options in how they wish to consume trial information. They also must understand their needs and preferences in order to see success from notifications, visuals, word choice, and other educational tools.
Unfortunately, while there is a bevy of data available from individual participants' preferences, there are yet to be clear themes or trends that have emerged from this data.
Keep it Simple
There’s no doubt that technology is changing the way in which our industry speaks to participants.
However, there’s one lesson that remains constant despite the change - simplicity.
The ways our industry speaks to participants must remain rooted in simplicity and ease of use. In order to help keep it simple, here are some tips from our PCN on how to best address research participants.
- Use clear, simple language. Aim for a 6th or 7th-grade reading level (approximately the level of a 12-year-old.)
- Keep paragraphs brief and use short words (1-2 syllables are best). Use words carefully. Don’t define patients by their diagnosis.
- Use people-first language. For example, Barry is a patient with optic atrophy, not an optic atrophy patient.
- Add glossaries or hyperlinks into technology when possible. Terms should be clickable so participants are able to remember or refer to them as they interact with the tool.
- Depending on the participant population, multiple modalities should be used to help facilitate and match the common learning styles of the populations expected to consent.
- For example, to make studies accessible for the visually impaired, eConsent language should be optimized for screen readers, and the use of video and audio should be optimized.
- If using video, then language, terminology, and dialect should be considered for your population.
- Make information easy to share with loved ones, community leaders, and key stakeholders.
- Provide a mechanism for interaction. Treat this as an opportunity to build rapport and establish a strong relationship between the site and the patient.
- Use jargon or dense language patients don’t understand.
- Treat the informed consent process as something to be done by the patient in a vacuum.
- Mimic a dense, jargon-filled paper consent form in terms of layout and presentation. Smaller amounts of information are more easily digestible.