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    Navigating Challenges in CNS Drug Development: The Rise of Hybrid Study Models

    Today’s clinical research landscape is evolving quite rapidly with technology. As such, integrating decentralised clinical trial (DCT) strategies into Central Nervous System (CNS) studies is a strategic imperative. Introducing digital endpoints has transformed how data is captured, quantified, and tracked, contributing to the growth of CNS DCTs

    According to GlobalData’s Clinical Trial Database, the CNS (26% of trials) is the most researched therapeutic area for DCTs. 

    CNS study conductors had to continue their research despite constraints during the pandemic due to the need for augmented therapeutic. They used virtual trials to do so, which led to a boom in CNS DCTs. 

    What emerged as a solution to address trial challenges during the global crisis has become the “new normal” in the CNS drug development industry.

    Balancing Optimism with Pragmatism

    As biotech and pharmaceutical businesses navigate the future landscape of CNS therapeutic development, a critical question arises: Do DCTs hold the potential to emerge as the solution for CNS clinical trials? The answer lies in the capabilities of digital endpoints to address the unique issues facing CNS trials.

    Promising DCT strategies for CNS drug development

    Remote Patient Monitoring

    Remote trials use continuous or point-in-time data tracking in home-based trial settings. That has proven to be highly effective in long-term patient monitoring. Remote patient monitoring (RPM) enables immediate detection of adverse events (AEs), ensuring patient well-being in chronic neuropsychiatric disorders. Sensors, trackers, wearables, and mobile health applications play a pivotal role in RPM. These help remotely monitor key neurological parameters, such as mood, motor skills, and cognitive function. RPM also helps identify compliance lapses—all while decreasing the burden on the patient and study team. 

    In-home Nurse Visit

    In-home nurse visits make CNS study easier by providing accurate assessment and a patient-focused approach to patient care and data compilation. It’s particularly beneficial for patients with special neurological conditions such as ALS, Multiple Sclerosis, Alzheimer’s disease, and Parkinson’s disease. Such patients may fail to meet the logistic demand of site visits in an on-site clinical trial.

    In addition, in-home nurse visits ensure continuous monitoring of disease symptoms and the effectiveness of the therapeutic deployed. It helps study teams detect issues faster. That, in turn, helps ensure timely intervention and adjustment in treatment programs.

    ePRO

    Electronic Patient-Reported Outcome (ePRO) has long been considered a cornerstone in DCT study models. The high-end capabilities of offering real-time data capture, improved compliance, and reducing recall bias have been marked as the driving force behind the fast adoption of ePRO in CNS DCT studies. In addition, high-end ePROs with DCT platforms such as ObvioHealth help upgrade CNS trials by delivering strong evidence.

    ePROs enable patients to conveniently complete questionnaires from their homes using their own devices. That reduces the burden on patients and improves data quality. That means less chance of data loss and augmented patient experience. That leads to improved compliance and a faster roll-out of more effective drugs for chronic CNS conditions. 

    Direct-to-Patient Drug Delivery

    Certain neurological issues, such as Amyotrophic Lateral Sclerosis (ALS), may limit patient mobility. For such patients, direct-patient drug delivery has emerged as a transformative solution. It’s also beneficial for patients who cannot participate in trials due to the need for on-site visits. Direct-to-patient drug delivery ensures patients still reap the benefit from treatments on trial without physically attending the sites.

    Gamification

    Gamification has been marked as a key force behind the fast adoption of digital and decentralised technologies in CNS studies. This approach keeps participants engaged through interactive activities. Gamification can help simprove patient engagement and retention rates.

    Other patients may have special neurological conditions such as ADHD or cognitive impairment disorders. For them, refurbishment or interactive activities serve a dual purpose—compiling real-time patient data while enhancing their cognitive functions.

    Challenges of DCTs in CNS Drug Development

    Even though deploying decentralised technologies can accelerate CNS studies, not all DCT strategies are equally effective across all disorders. Some conditions require intensive care and in-person interventions/inspections that are challenging to ensure in completely remote trial settings. For example, patients with chronic neurological disorders, such as Epilepsy or Alzheimer’s require continuous in-person monitoring to ensure accurate assessment of their cognitive condition and motor deficits. That is a big challenge in the remote study model. 

    Navigating Challenges to Success with a Hybrid Approach

    Considering the complexities and challenges associated with neuropsychiatric studies, leading Clinical Research Organisations (CROs) prefer taking a hybrid approach to CNS trials. Incorporating traditional methods with decentralised strategies whenever required, hybrid study models have emerged as a more flexible approach to ensuring augmented patient experience while enabling them to easily access experimental treatment.

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