The Future of CNS Trials
An estimated 1 billion+ people worldwide suffer from some form of central nervous system (CNS) disease. While the need is great, progress to better understand and treat CNS disorders has been slow, and at times, disappointing.
Numerous drug treatments for debilitating diseases such as Alzheimer’s and Parkinson’s have made it to mid- and late-stage clinical trials only to fall short in the end of meeting the needed safety and efficacy measures to secure approval. And R&D spending in CNS medical treatments, including mental health, continues to lag behind investment in other diseases. As our population ages, the percentage of those suffering from neurological diseases will continue to grow. It’s imperative that we continue to invest in research to discover new treatments and improve and extend the quality of life of those inflicted.
Fortunately, the future of CNS research looks brighter – with new breakthroughs in R&D and the advancement of new digital ePRO technologies such as patient wearables, sensors and devices to help with measurement and data collection. As we enter this new era, it’s essential that you partner with a CRO that understands the challenges – old and new –and has the expertise to operationalize and de-risk your clinical trial successfully.
CNS trials can be complex and challenging to execute for a variety of reasons. Finding patients who are qualified and willing to participate and stay enrolled in many of these studies can be difficult. Compliance is also a hurdle. The critical role that caregivers play in the successful enrollment and retention of patients in CNS trials cannot be understated. Perhaps one of the greatest challenges is the accurate and consistent collection of primary and secondary endpoint measurements for CNS trials.
Overall, Aperio’s team members have an average of 18 + years of experience managing and executing CNS trials. Our team’s clinical development experience in CNS means we understand the hurdles often faced in CNS studies, including:
- Management of rater training for endpoint assessments
- Management of validated measurement tools, including assessment scales, tests and questionnaires
- Appropriate caregiver education and consenting
- Eligibility review and confirmation
- Integration of complex ePRO assessments with trial data
- Decentralized trial approaches
- Utilization of patient wearables, sensors, ePRO devices
- Centralized imaging mgmt. – MRIs, CT and PET scans, EEGs
- Operationalizing complex, challenging protocols
- Risk identification and mitigation strategies, including centralized monitoring and real-time data visualizations
- Parkinson’s Disease
- Lewy Body Dementia
- Alzheimer’s Disease
- Sleep Disorders
- Multiple Sclerosis
- Tardive Dyskinesia
- Tourette Syndrome
- Traumatic Brain Injury
I am so glad to hear that you are enjoying the study and working with Aperio. In my opinion, they are the best CRO with whom I have ever worked!
The Aperio team has been a delight to work with! The team is organized, responsive, and efficient. They interact with our sites professionally and promptly. Aperio truly works with us to help us achieve our study goals. We look forward to continuing to work with them as our study partners in the future.