Pharmaceutical and biotech companies are diligently working to develop new therapeutics to meet the massive global burden caused by CNS diseases. Despite this, CNS therapeutic development successes are notoriously scarce.
Individuals with CNS conditions can experience mobility and cognitive issues and require regular caregiver support, making these trials complicated and burdensome for both participants and their caregivers. In many cases, medication adherence can be a challenge: Participants may stop using the therapeutic when they feel better. And, in studies collecting subjective endpoints, data variability can derail your results.
With so many challenges, getting a CNS trial to completion can be far from linear. To succeed, you need a partner that can design, deploy, and deliver your study with scientific rigor and operational accountability.
1. Nuno Perez Á, Suarez J, Le Bars M. Sizing the brain. Deloitte Insights. February 14, 2023. Accessed January 8, 2024. https://www2.deloitte.com/uk/en/insights/industry/health-care/global-neuroscience-market-investment-report.html
2. Wong CH, Siah KW, Lo AW. Estimation of clinical trial success rates and related parameters. Biostatistics. 2018;20(2):273-286. doi: 10.1093/biostatistics/kxx069
3. Myers W. CNS Drugs Take Longer to Develop, Win Approval. CenterWatch. September 17, 2018. Accessed January 9, 2024. https://www.centerwatch.com/articles/12495-cns-drugs-take-longer-to-develop-win-approval
Each CNS indication has its distinct challenges. Careful attention must be paid to best practices for reducing participant burden, ensuring data accuracy, minimizing placebo effect, and boosting retention and compliance. These will vary depending on the patient population, protocol requirements, and desired endpoints. ObvioHealth’s digital methods provide concrete solutions to help mitigate the risks.
A Phase IV trial designed to collect data from a real-world population—adults with ADHD and co-occurring mood symptoms. This study requires ClinROs, PROs, and the capture of at least one vital sign. How do you reduce burden when a study requires multi-source data capture?
A study to measure quality of life impact on clinically depressed participants that also meticulously monitored suicidality. How do you keep participants with mental health disorders safe?
A medical device migraine trial requiring a long run-in period to ensure participants with the right type of headache were included. How do you keep participants engaged even when they’re not on active treatment?
ObvioHealth tackles CNS studies with its unique combination of science, innovation, and pragmatic study management.
"ObvioHealth helped us figure out how to keep patients engaged without giving them more migraines. Incorporating the live chat feature and notifications into the project has eased the connection for the participants."
“I had all my questions answered. It was simple.”
“The entire process was very simple and easy to navigate.”
“I sent a thank you note when I was done, because I felt like I had a kind of personal relationship with the staff.”
"It was pretty much seamless from the start. From scheduling the whole appointment and the contact, there was always help from the research team.”
“I have been involved in other studies where I carried around their study device. Having the app on my phone and just one device, made it so much easier ”
“I would just get the notification and then go to the app and answer the survey questions. They had a screening questionnaire, and it was just easy to just go through and mark my answer, go to the next activity and hit submit.”
The challenges associated with conducting central nervous system clinical research all impact sponsors’ and study teams’ ability to gather stronger therapeutic evidence—but they also prime CNS studies for decentralization.
Depression was ranked as the world’s second-most frequent mental health disorder leading to disability in 2019.
Pain is a universal human experience—and finding ways to relieve or better manage it continues to be a priority for the life sciences.