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.
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.
DCTs can bring studies directly to patients, thereby addressing issues of patient recruitment and retention:
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.
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.
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.
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.
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:
Meanwhile, an electronic clinical outcome assessment (eCOA) platform streamlines the expert review process, augmenting expert assessments by:
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.
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:
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.
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.