Clinical trials that focus on Central Nervous System (CNS) indications are consistently more successful when handled by a CRO with extensive experience in the field.
These trials often bring about their own particular set of challenges, which make them more expensive than other subspecialties.
Some of the critical issues that need to be handled include:
- The lack of objective endpoints, especially for psychiatric medication
- The need to account for behavioural and cognitive performance effects, which are more complex to assess than laboratory values
- The possible need for very-long-term follow up, especially for Phase 4 studies
- CNS trial subjects may be partially dependent or cognitively challenged, making issues such s informed consent trickier.
When choosing a CRO for a CNS study, it is essential to look at the company’s previous track record and its ability to implement non-traditional ways to gather and assess data. This will help bridge the gap between everyday function and the objective numbers needed to support a trial’s results.
CNS Clinical Trials Market
Currently, there are 141 ongoing trials registered in Europe that deal with nervous system diseases. After oncology, CNS disorders make up for the second-largest indication for pharmaceutical studies. The niche is expected to grow significantly over the coming years and exceed 205 billion USD by 2028.
When looking at these figures, it should be noted that CNS clinical trials often intersect with other fields, in particular oncology and nephrology.
Some of the prominent trends shaping the CNS trial scene include:
- The numerous ongoing neurodegenerative disease trials, which account for 40% of the entire CNS clinical trials field
- The increasing popularity of trials dealing with cancers that affect the CNS, which constitute the largest growing sector
- Although the most significant investments in the field are held in North America, the Asia Pacific region is experiencing the fastest growth
The CNS clinical trial market encompasses the following indications:
- Neurodegenerative diseases
- Neurovascular diseases
- Medical devices for CNS trauma rehabilitation
- Mood disorders
- CNS Cancers
Why Outsource to a CNS CRO?
In many cases, the causes of neurological or nervous system diseases are still not fully understood. Because of this, trial design and management need to be handled by an experienced team that can get around the uncertainty and produce relevant and significant results.
A CRO that can demonstrate prior success in CNS trials is more likely to provide:
- Flexible patient recruitment models, which make up for the relative scarcity of patients
- Access to key opinion leaders to help raise awareness about the trial
- Thorough support services for patients and families, especially for patients with mobility problems or cognitive impairment
Further, budget management for CNS trials also requires special care, especially for neurodegenerative disorders. Here, there are two main cost drivers: the longer-than-average length of the study and their reliance on imaging to monitor results.
How to Choose the Right CNS CRO?
Relationships between CRO and Sponsor should be developed slowly, working on smaller projects or consultancies before launching a large-scale trial. The following 4 points will provide a solid basis for a successful partnership:
A proven track record in the speciality
Expertise and past success within the CNS niche are perhaps the most important criteria to look for in a CRO. In particular, Sponsors should look for partners who have worked with similar protocols already.
An unblemished reputation in bioethics
CNS trials are more likely to deal with mental or cognitive disabilities. Because of this, most ethical watchdogs tend to be particularly exacting when surveilling these trials. The reputation of the CRO can play a major role here
Good budgetary practices
Sponsors who have had the opportunity to work with a CRO before can gain valuable insight into the latter’s budget and management practices. Critical relevant skills here include accurate projections, the ability to mitigate unexpected events and draft detailed and well-defined service orders.
Existing relationships and partnerships
Often, CROs act as a bridge between a site’s clinical staff and the Sponsor’s needs. A CRO that has previously fostered goodwill on a specific site or hospital can bring a lot of goodwill to the table and boost the team’s morale.
Top CNS CROs
At TrialTop, we have identified various CROs that list central nervous system disorders as one of their areas of expertise. These encompass large and mid-sized companies in the United States, Europe, and the Asia Pacific region.
Some of the largest include:
- Syneos Health