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.
Democratizing Clinical Trial Awareness and Access
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:
- Engage in Community-Based Participatory Research (CBPR)3: This research approach involves participants as stakeholders to improve health outcomes. Patients can engage with their clinical team to align recruitment, retention, and study protocol with effective patient outcomes.
- Establish Healthy Patient-Clinician Channels: Healthcare professionals need to overcome historic mistrust with minority communities. Clinical trial stakeholders should better reflect the makeup of the local population, while also bringing clinical trial knowledge to the places minorities are seeking care and educating themselves on the different genetic makeups of their diverse patient cohorts.
- Rethink Your Intake Forms: Despite evidence that minority populations are at higher risk for certain chronic conditions, few intake forms collect race or SOGI (sexual orientation and gender identity) data.4 This information is crucial to improving minority and LGBTQ+ health outcomes.
- Reduce Trial Burden with DCT: Patients working hourly jobs, serving as single parents, or living in more remote geographies have notoriously suffered higher dropout rates. Decentralized technology is helping ensure better access across geography, race, sex, and age, while also improving data necessary to understanding dosing, efficacy, and safety.
Actively Seeking Patient Feedback on Study Protocol
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:
- Nurturing relationships with patient advocacy groups or advisory panels.
- Creating patient advisor roles or engaging with formal steering committees.
- Engaging with patients via portals or patient networks.
- Hosting patient focus groups or surveys.
- Conducting one-on-one interviews with patients.
- Encouraging former participants to share their experience.
Once feedback is collected, it’s imperative to put it into practice. Clinical trial operators can implement patient feedback in the following ways:
- Modify trial design elements to ensure patients find value in the study outcomes.
- Restructure recruitment using patient feedback to update key messages and outreach materials.
- Provide support for barriers identified by the patient feedback (i.e. study format, location, scheduling, and length).
- Identify condition-specific responses that impact trial design.
Streamlining Patient-Reported Outcomes
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.
Investing in Informed Consent
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:
- Create Health Literacy: Use plain language on all patient-facing forms and avoid heavy medical jargon so patients can understand what is being asked of them.
- Enrich Your Forms: Leverage eConsent forms that can be enhanced with digital videos, quizzes, or gamification tactics that better engage with a lower health literacy population.
- Support Consent Discussions: Offer opportunities for patients to address fears and anxieties with a healthcare professional before providing informed consent documentation.
- Offer Translations: Ensure comprehension across broad patient populations by offering consent translations in local languages (and make sure the translated information is still easily digestible).
- Actively Check on Consent: Don’t assume that a lack of questions means patients understand your consent forms. Actively check on their comprehension throughout the course of the trial.
- Offer Additional Support: Provide supplemental information to the consent form, such as educational videos or information pamphlets, that help answer more specific questions.
A Patient-Centric eClinical to Aid Meaningful Outcomes
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!