The narrative around patient engagement in clinical trials has remained largely unchanged in the last few decades. An alarming number of studies fail to meet their recruitment goals or experience underpowered outcomes due to heavy drop-out.
Why do clinical trial recruitment and retention continue to plague the industry, even despite a recent upswing in patient-centric solutions and study models? In short, many trials fail to align their study protocol with patient-relevant outcomes. Clinical research should be conceived and designed with the patients in mind to ensure treatment choices produce meaningful outcomes.
We will explore several patient engagement strategies that sponsors, CROs, and clinicians can adopt to align their study protocol with relevant patient outcomes.
Despite recent discussions about the need for diversity in clinical trials, the reality is that a disparity still exists. Hispanic populations represent 18 percent of the U.S. population, but make up fewer than one percent of trial participants.1 Few intake forms gauge sexual orientation, despite heavy research that shows differences in medical risks, healthcare access, behavioral and physical health among LGBTQ+ populations. There is even research to support specific patient cohorts that rely on, and prefer direct clinician-to-patient treatments over virtual options.2
Overlooking these patient populations can be detrimental to the outcome of your research. Clinical trials need to accurately reflect the makeup of the population to ensure treatments are safe for people of varying backgrounds and lifestyles.
In order for treatment outcomes to account for a broader range of patient populations, the industry needs to consider what makes patient cohorts unique. Researchers must get to know their patients again and remove known barriers that preclude certain minority populations from participating in clinical research.
Prior to the start of any study, clinical trial operators should take the following steps to democratize awareness and access for all patient cohorts:
The goal of clinical research is to improve patient care and health outcomes. Yet many trial outcomes fail to translate to clinical benefits for patients due to poorly chosen outcomes, inaccurate data collection, or underpowered trials.5 Misaligning study protocols with meaningful outcomes can result in costly amendments that add up to 90 days in development time and can end up costing sponsors as much as $141,000 per amendment.
Although patients may not be medical experts, they can provide critical insight on protocol design and recruitment strategies that achieve better health outcomes and avoid costly amendments before they happen. To involve patient feedback in your study builds, consider adding patient-led roles within your clinical team that collects and translates patient feedback into trial endpoints.
Feedback from patients can be collected organically through:
Once feedback is collected, it’s imperative to put it into practice. Clinical trial operators can implement patient feedback in the following ways:
Once a patient is enrolled in a trial, the pursuit for meaningful outcomes does not end. Sponsors and CROs must identify what keeps patients entering and providing accurate data throughout the course of the trial to ensure the most accurate outcomes.
Replacing paper processes with ePRO solutions has proven to not only improve patient adherence by 60 – 80%, but it can also improve patient engagement and strengthen trial outcomes. Patients can leverage ePRO on their mobile device, making it easy to receive reminders, view dosing schedules, and enter data on a familiar device. Patients can trust that their clinicians have real-time access to their information, and their clinicians can make data-driven decisions that support more meaningful outcomes.
Involving patients in the build of your PRO design can further benefit your health outcomes. An oncology study found that doctors only detected patient symptoms half of the time without PRO. When ePRO was utilized on oncology patients, the patients reported improved quality of life, increased survival, and fewer visits to the ER.
By engaging with patients on ePRO design, clinicians can better inform regulatory approvals and drug labeling, identify new information on the burden of a disease, monitor the live status of patients, and provide timely care that is tailored to a patient’s unique needs. All of these benefits result in stronger health outcomes for patients and trial operators alike.
It’s estimated that one in three American adults have below-average health literacy.6 Applying principles of health literacy to clinical research is necessary to help patients make well-informed decisions with their health information. In addition, confusing consent and health forms can cost sponsors and CROs lost time, revenue, and jeopardized trust between clinicians and patients.
To bridge the gap between patient adherence and engagement in the consent process, trial operators should implement the following changes:
To produce the most meaningful outcomes, clinical trial operators need patient-centric eClinical technology that fosters patient engagement and produces quality data points. Medrio’s integrated eSuite of decentralized solutions was created with the patient-clinician relationship in mind. We don’t believe that you should have to choose between an intuitive interface for patients and pre-validated, high-quality solutions for your clinical team.
Whether you’re operating an in-person, hybrid, or fully virtual trial, our flexible solutions keep you in full control. Build your study in a matter of days so you have more time to focus on what matters—your patients and their health outcomes.
Learn more about our patient-centric eSuite with a custom demo today!