Some might say that information overload is the first step in learning about clinical trials. A quick google search for “understanding clinical trials” yields over 71 million results: with hundreds of downloadable guides, books, and databases for patients trying to understand the ins and outs of the research process. It can be overwhelming to simply pick a resource that simplifies information in a digestible manner, let alone begin to process the information itself. The common thread throughout patient communities — regardless of research — is just that: the clinical trial process is often so daunting to begin to understand, that it is avoided altogether.
Asking My Own Patient Community for Feedback
When I reached out to my own rare disease and ePatient community, three barriers to understanding clinical trials were repeatedly mentioned by patients and caregivers:
- The difficulty of finding a clinical trial database that imparts information in such a way that information is understandable and digestible, with a user-friendly interface.
- The sheer volume of information provided when in recruitment or involved with informed consent for a trial, coupled with the complexity of the jargon used in those materials, can be especially overwhelming. And all the more so when the trial involves a life-limiting condition, such as an autoinflammatory disease or rare dermatologic disease.
- Patients in the rare disease community reported feeling as though the language used in trial materials as well as jargon used by healthcare providers themselves, often fails to communicate an appreciation for the gravity of the situation at hand. They underscored how crucial it is that the people involved in coordinating a trial and the materials they use for patient education convey an understanding of the emotional impacts a patient may be experiencing, and how stressful learning about the clinical trial process can be.
It was clear from talking with my own community that when a trial is designed without patients as stakeholders to guide materials, everything from the colors and words chosen for brochures to the wording of consent forms can negatively impact our experience and understanding of research. And perhaps most importantly, a key step in the process of participating in studies was overlooked: the learning process prior to even enrolling in a trial.
Working Together to Improve Understanding
What does this mean moving forward? How might we design future materials with these barriers in mind, and, how might we make understanding current clinical trials more digestible for participants now?
First and foremost, using a patient-centered approach, for example, employing patients as consultants and stakeholders in clinical trial design, but what’s more — inviting patient experts to be a part of work that happens upstream, using patient experience as a guide to developing materials with easy-to-understand language. A straightforward synopsis explaining the trial would be extremely helpful! When the resources for learning about a trial result in information overload, we need to have platforms in place that allow prospective and current clinical trial participants and their loved ones to pose questions and concerns as they arise.
For all stakeholders, it is paramount that we do not lose sight of the patient experience in the realm of research. Behind the consent forms, paperwork, numbers, statistics, and p values are people. For clinicians, their role in the research process is part of their experience as a provider or principal investigator — it is an integral part of their profession. For patients, their role in the clinical research process is interwoven into the very experience of their health or disease — it is immensely personal. How we communicate support for participants, foster understanding, and create dialogue before information overload takes place, shapes not only the current framework for clinical trial participants, but lays the foundation for the future.