By Jen Horonjeff, PhD., Founder and CEO, Savvy Cooperative
As an advocate for patients and a patient myself, I’m often asked the question, “Why don’t more patients participate in clinical trials?” There are many reasons I hear from fellow patients about why they have not participated in a clinical trial, including not being aware of trials as a treatment option, not knowing where to find trials they are eligible for, and not wanting to be a “guinea pig” in the name of research.
At the heart of all these reasons is a lack of information and processes that meet patients where they are. For those patients who are reticent about clinical trials, we need better education around trials and more transparency surrounding what exactly they are signing up for if they do participate. For those who are actively seeking to understand if a clinical trial is right for them, we need to make it easier for them to find trials they qualify for and simplify enrollment and participation. As a patient, little is worse than making an already lousy situation – being sick – worse because you can’t access the help you need.
Some patients may ask their doctors about clinical trials, only to learn their clinicians know less about research possibilities than they do. This is especially common if patients are seen in community settings or private practices not associated with the kind of large academic medical centers that usually serve as clinical trial sites. Other patients may seek out trials themselves. Unfortunately, many resources like Clinicaltrials.gov are not easy to use, which can make this process feel like some form of cruel punishment for an already exhausted patient searching for answers.
If we want to create more empowered patients, we need to help them gain access to the information they need, whether they are seeking to start a discussion with their clinician, assess their eligibility, or sign up to enroll. If we can take the headaches out of the equation, we can help more patients enroll in trials and hopefully get the care they need.
And while what I say next sounds simple, it’s oftentimes overlooked: we need to tell patients what they want to know.
A key consideration for patients thinking about trial participation is this: “Can I do this?” They want to know:
A) if they’re eligible and qualify for the study
B) how the study and its requirements fit into their lives
If we want to create more inclusive trial participation, you shouldn’t need a PhD or MD to decipher trial recruitment material. Heck, I have a PhD and I don’t understand the half of it. Study descriptions, trial protocols and requirements, and eligibility criteria all need to be conveyed as clearly, simply, and transparently as possible. Sponsors should make it easy for those interested to easily identify:
- Inclusion and exclusion criteria – especially in regard to exclusions due to co-morbidities like diabetes or other conditions
- Frequency of appointments and tests, and whether they can be done remotely or locally
- Travel and time expectations related to clinical visits
- Expectations for caregivers or support team members
- Responsibilities related to in-home, remote data collection
- Remuneration and/or if they may incur any out-of-pocket expenses
By making candidates aware of these things from the very beginning, we save their valuable time and reduce any stress that would be involved in pursuing a study they won’t be able to join. They can then use this time to find other studies they’re better suited for. For sponsors, they get inquiries from candidates who are more likely to be eligible for enrollment. Less time is wasted disqualifying huge numbers of candidates and studies can get started more quickly. Patient-centricity isn’t a concept that only works in the clinical care setting. By spending time taking the patients’ perspectives into account when designing research studies and, particularly, developing recruitment strategies and processes, the clinical trials space can ease the path into trials and see improvements to study enrollment.
For more information about Dr. Horonjeff and her work to make patients’ voices heard in healthcare innovation, visit savvy.coop.
For more information about Trialbee’s data-driven clinical trial recruitment solutions, visit trialbee.com