ePRO for CNS: How DCT Solutions Address Four Key Challenges in Central Nervous System Research
ePRO CNS
Let’s dive into how decentralized clinical trials (DCTs), leveraging a modular approach, can address four key challenges in central nervous system research to reduce participant uncertainty and burden, increase participant compliance, and drive data quality.
Challenge: Recruiting and retaining patients is costly and time-consuming.
Struggles with recruitment and retention can cause significant lags in clinical studies. This is the foremost reason why CNS trials often require a longer duration than those in other therapeutic areas.
A vital underlying factor: CNS health conditions can limit patients’ mobility and energy, prohibiting them from traveling to clinical research sites. In fact, many patients who stand to benefit the most from a new treatment also confront the biggest barriers to study participation.
Solution: Digital solutions, including eConsent and ePRO, lighten the participant burden.
DCTs can bring studies directly to patients, thereby addressing issues of patient recruitment and retention:
- Study teams reach and recruit a larger pool of right-fit participants through cost-effective targeted digital advertising.
- Patients fully understand the study’s goals, requirements, and tasks with comprehensive digital patient education and accompanied eConsent.
- Participants enroll and complete the study tasks, such as ePRO, from the comfort and convenience of their homes using their own mobile devices.
- In cases where in-person, site-based interaction is needed, DCTs often minimize the travel needed (e.g. by partnering with local pharmacies).
By reducing the participant burden from start to finish, DCT and hybrid models broaden the pool of potential participants while also ensuring that they are supported and allowed the flexibility needed to supply quality data.
Challenge: CNS diagnoses carry a stigma, which can impact recruitment.
Much like reproductive and women’s health, many CNS conditions are still considered “taboo,” both on a cultural level and by patients themselves. Some patients may hesitate to enroll because of concerns about disclosing personal health information, being judged or typified, or being otherwise negatively labeled.
Solution: DCT and hybrid studies offer privacy tailored to a patient’s preferences.
When discussing sensitive health topics, many patients benefit from interacting with clinicians and researchers through a screen rather than face-to-face. With a decentralized study, patients can achieve a comfortable distance from the study team—close enough to access support when needed but removed enough to be discreet.
Challenge: Human subjectivity can skew trial outcomes.
Patient- and clinician-reported outcomes provide the basis for measuring many endpoints in CNS trials. For example, participants may rate the frequency and severity of pain they experience during a migraine episode.
While these outcomes are important to capture, they are also prone to recall bias or skewed perceptions—particularly when there’s a long waiting period between experiencing and reporting a symptom. There is also the concern of variability within the expert rating process, which is subject to human error and can further impact data quality.
Solution: Augmented reporting and assessment drives data quality.
Achieving 100% objective reporting may not be realistic for every CNS condition. But, leveraging technology to support humans can drive more accurate, consistent results.
Electronic patient-reported outcomes (ePRO) and electronic clinician-reported outcomes (eClinRo) allow participants and clinicians to submit real-time data on behaviors and symptoms. With ePRO, patients can:
- Use their own devices to capture and share key data points as they occur.
- Share adverse events in real time rather than relying on memory recall or waiting for the next in-person study appointment.
- Easily submit unstructured data such as audio, video, or images, which give color and context to electronic diaries and questionnaires.
Meanwhile, an electronic clinical outcome assessment (eCOA) platform streamlines the expert review process, augmenting expert assessments by:
- Funneling relevant data into a single dashboard.
- Minimizing inadequate submissions.
- Addressing variability among experts.
- Incorporating machine learning to improve accuracy over time.
Challenge: Patients drop off or are lost to follow-up.
In CNS studies, the stakes are extremely high—this research focuses on critical functions within the brain. As a result, staying in touch with participants over time is essential, both for the study outcomes and for patients’ well-being. Participants who drop off during the trial, or are lost to follow-up over subsequent months, pose a major concern for study teams.
Solution: Virtual site teams and intuitive tools keep patients engaged with end-to-end support.
DCT and hybrid studies offer patient-centric processes and ongoing support to keep participants engaged throughout the study and over time. These studies use human-centric design to meet patient needs with flexibility while also ensuring their safety, including:
- Real-time data collection: Designing multi-functional, intuitive digital tools helps participants to capture and submit data with ease, reducing patient burden and supporting study task compliance.
- Remote patient monitoring: Continuous or point-in-time data is monitored by a dedicated study team to ensure patient well-being and to swiftly determine the occurrence of any adverse events (AEs).
- Virtual site team: Expert staff helps participants stay compliant throughout the study by checking in with patients regularly, answering questions, and being accessible via chat and phone.
- Mobile apps: Having a digital touchpoint with participants helps study teams stay in contact long-term.
Well-designed DCTs don’t replace the human component of clinical research—they simply support humans in new ways at every stage of the trial.
Looking Ahead to the Future of ePRO CNS Research
More than 4,000 CNS clinical trials are expected to be underway by 2026, according to Evaluate Pharma. And, these trials involve an elevated sense of urgency, according to researchers writing in the journal Therapies: “Central nervous system disorders remain the leading causes of mortality and morbidity worldwide, affecting more than 1 billion patients,” the authors indicate. “This therapeutic area suffers from high unmet medical needs and the search for innovative approaches to identify therapeutic strategies is urgent in the field.”
The potential for DCT models within CNS research can meet this urgency with broad applications. By providing a multi-pronged solution, DCTs can address many of the challenges inherent in CNS trials, ultimately accelerating the speed to market for life-changing new treatments.
