Decentralized clinical trials (DCTs), which leverage digital technologies and patient-centered strategies, emerged quickly during the pandemic as a necessary augmentation to allow clinical research to continue despite the challenging environment. However, as pharmaceutical and biotech companies explore this new frontier more deliberately, interest has cooled somewhat as they assess the best path forward. Companies still face a critical question:
Are DCTs the future of Central Nervous System (CNS) drug development or simply another set of tools to power the next generation of CNS trial conduct?
Many sponsors, particularly those focused on CNS diseases, are cautiously optimistic about DCTs but also aware of their limitations. As such, a hybrid model that combines traditional in-person trials with decentralized strategies is often preferred in the CNS research space. This approach maintains the robustness of clinical research while extending the reach and convenience of trials for patients and investigative sites.
Several DCT strategies hold promise for CNS drug development, offering potential benefits such as increased patient recruitment, improved adherence, and enhanced data collection.
These can be highly beneficial for patients with conditions such as Alzheimer’s disease, Parkinson’s disease, Multiple Sclerosis, and ALS. By bringing skilled care into the patient’s home, we can reduce the stress and physical burden of travel, particularly for those with mobility limitations or advanced disease stages. In-home visits can also provide unique insights into a patient’s everyday functioning, potentially improving the sensitivity of assessments.
This brings investigational drugs directly to patients’ homes, which can be crucial for those who have mobility issues or live far from clinical sites. This strategy can be beneficial for CNS diseases like Amyotrophic Lateral Sclerosis (ALS), where patients may have severe physical disabilities.
Products like wearable devices provide real-time data on patient health metrics, offering invaluable insights into treatment efficacy and patient adherence. For conditions like Parkinson’s disease, where symptom severity can fluctuate throughout the day, wearables can help capture these variations in a way traditional clinical visits may miss.
Commonly used in traditional CNS trials, ePRO tools are a vital component of decentralized clinical trials. They allow patients to report symptoms and side effects in real time, providing a more comprehensive and accurate picture of the patient’s experience. For CNS trials, ePRO can enhance our understanding of disease progression and the impact of interventions on quality of life.
This can be a powerful strategy to keep patients engaged in clinical trials. Gamified elements can transform mundane or repetitive tasks into enjoyable activities, thereby improving patient participation. In CNS trials, especially for conditions like ADHD or cognitive impairment disorders, games can serve a dual purpose of collecting data while improving cognitive functions and maintaining patient engagement.
Centralized vs Decentralized Raters: When to Use Which in CNS Trials?
These strategies, coupled with a keen understanding of the unique challenges and opportunities in CNS drug development, offer the potential to transform clinical research in the CNS domain. By adopting a patient-centric approach, we can enhance the participant’s experience, improve data quality, and accelerate the development of new therapies for CNS diseases.
However, not all DCT strategies are equally effective across all CNS diseases. Some conditions may require in-person assessment or interventions that are difficult to conduct remotely.
For instance, Alzheimer’s Disease and other dementias can be challenging to monitor remotely. While telemedicine and digital health coaching may provide some insights, nuanced changes in cognitive functions and motor deficits can be difficult to assess without face-to-face interaction.
Similarly, for conditions like Epilepsy, where seizures can be non-convulsive and hard to detect remotely, traditional in-person evaluations may still be necessary to monitor medication side effects and overall health status.
Given these complexities, many sponsors have adopted a hybrid approach to CNS drug development. Hybrid trials combine traditional and decentralized methods, offering a flexible approach that caters to the needs of different patient groups and disease states. Not everyone is willing to go fully virtual/decentralized with their clinical trial.
This hybrid model enables sponsors to leverage the advantages of DCTs techniques, to support broader patient recruitment and improved convenience, while preserving essential aspects of traditional in-person trials.
Effectively Managing Rater Training and Consistency in CNS Trials
While DCTs present an exciting opportunity for improving the efficiency and patient-centricity of CNS drug development, a thoughtful, hybrid approach seems most promising. By tailoring trial design to the unique needs and challenges of different CNS conditions, sponsors can ensure that innovation enhances, rather than compromises, the quality of clinical research.
In the evolving landscape of clinical trials, flexibility, patient-centricity, and careful consideration of disease-specific needs are key to success. The future of CNS drug development is not simply about being fully traditional or decentralized, but about finding the right balance that delivers the best outcomes for patients, investigators, and sponsors alike.
Partnering with a seasoned CNS clinical research organization (CRO) can be the key to unlocking this balance. Our experts are wired for CNS, bringing the experience, expertise, and innovative solutions to tailor DCT strategies to your specific needs. By powering your clinical trials with their support, you can elevate your CNS drug development program to unprecedented heights, transforming patient experiences, enhancing data quality, and accelerating your path to market.
The future of CNS drug development is here, and with the right partner, you can be at the forefront of this exciting era.
Robert Bauer is an Executive Director of Operational Strategy at Precision with over 20 years of clinical trial operations experience from both the sponsor and CRO perspectives. He has led teams in the conduct of trials from Phase I through IV and has experience across a wide variety of trial designs. Bob has experience across many therapeutic areas some of which include rare diseases, oncology, depression, schizophrenia, and substance use disorders.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
