The Central Nervous System (CNS) plays a crucial role in every aspect of human function, from movement to cognition. When disorders affect the CNS, they can cause significant disruption to patients’ lives. Treating CNS disorders requires not only accurate diagnosis and effective treatments but also a well-structured approach to central nervous system clinical studies that keep patients engaged and committed.
In this blog, we’ll explore the challenges of patient retention in CNS clinical trials, particularly in hybrid studies, and how mdgroup is using patient-centred strategies to improve retention rates and enhance the trial experience.
What is the Central Nervous System?
The central nervous system consists of the brain and spinal cord, which are responsible for processing and transmitting information throughout the body. It plays a key role in every bodily function, from voluntary movements to involuntary processes like breathing and heart rate regulation. Given its complexity, diseases affecting the CNS can significantly impair patients’ quality of life.
The central nervous system is responsible for a wide range of functions, including:
- Movement control: Sending signals to muscles to initiate voluntary and involuntary movements
- Sensory processing: Interpreting signals from the senses (sight, sound, touch, etc.) and responding accordingly
- Cognitive functions: Managing thought processes, memory, learning, and decision-making
- Autonomic functions: Regulating involuntary activities like breathing, heart rate, and digestion
Central nervous system disorders
Central nervous system disorders come in many forms, ranging from neurodegenerative diseases like Alzheimer’s to epilepsy and multiple sclerosis (MS). These disorders present unique challenges for both diagnosis and treatment, especially since symptoms often evolve over time and may be difficult to detect in their early stages. Common CNS conditions include:
- Alzheimer’s disease: A progressive neurodegenerative disease that affects memory and cognitive function
- Parkinson’s disease: A movement disorder characterized by tremors, rigidity, and bradykinesia (slowness of movement)
- Multiple sclerosis: An autoimmune disease where the body’s immune system attacks the protective covering of nerve fibres, leading to disability
- Epilepsy: A neurological disorder marked by recurrent, unprovoked seizures
- Stroke: Occurs when the blood supply to part of the brain is interrupted, leading to sudden neurological deficits like paralysis or speech difficulties
However, in addition to these well-known conditions, there are also rare central nervous system (CNS) disorders. These disorders may not be as widely recognised, but they can have a profound impact on patients’ lives. Due to their rarity, these conditions often go undiagnosed for extended periods, and treatment options may be limited. Some examples of rare CNS disorders include:
- Amyotrophic lateral sclerosis (ALS): Also known as Lou Gehrig’s disease, ALS is a progressive neurodegenerative condition that affects the nerve cells responsible for controlling voluntary muscle movements, leading to muscle weakness and atrophy
- Huntington’s disease: A hereditary disorder that causes the progressive breakdown of nerve cells in the brain, leading to motor, cognitive, and psychiatric symptoms
- Neuromyelitis optica (NMO): An autoimmune disorder that affects the spinal cord and optic nerves, causing severe, acute attacks that can result in blindness or paralysis
- Alexander disease: A rare, fatal disorder caused by mutations in the glial fibrillary acidic protein (GFAP) gene, leading to the accumulation of abnormal protein in the brain’s glial cells, which disrupts normal brain function
- Schilder’s disease: A rare demyelinating disorder that can present with symptoms similar to multiple sclerosis but is distinct in its pathology and progression
Each of these disorders brings its own challenges, but as research continues to advance, there is hope that these conditions will be better understood, leading to earlier diagnoses and more effective treatments to improve patients’ quality of life.
Risk factors and symptoms
Central nervous system disorders can be influenced by a range of factors, with genetics, age, environmental factors, and lifestyle choices all playing significant roles. Family history, for instance, can increase the likelihood of conditions like Alzheimer’s disease and multiple sclerosis. Age is another key factor, as many CNS disorders, including Alzheimer’s and Parkinson’s disease, become more common in older adults. Environmental exposures such as toxins or infections, as well as lifestyle factors like poor diet, lack of physical activity, and excessive alcohol or drug use, can also contribute to conditions like stroke and dementia.
Symptoms of CNS disorders can vary depending on the specific condition but commonly include memory loss, confusion, difficulty with movement or coordination, seizures, sudden numbness or weakness, speech difficulties, and unexplained mood changes or depression. If any of these symptoms are present, it’s essential to seek medical attention for an accurate diagnosis and appropriate care.
The role of clinical research in central nervous system disorders
Ongoing clinical research into central nervous system disorders is actively investigating treatments that aim to modify the disease course, manage symptoms more effectively, or even prevent these conditions from developing.
Clinical trials are an essential part of clinical research when it comes to testing new drugs, therapies, and medical devices that aim to address the complex challenges posed by CNS conditions. These trials are critical for determining the safety, efficacy, and potential side effects of new treatments. By enrolling patients in these trials, researchers are able to gather valuable data that can guide the approval of new treatments by regulatory agencies like the FDA and EMA. Beyond evaluating existing treatments, clinical trials also explore the underlying mechanisms of CNS disorders, providing insights into how these diseases develop and progress.
For patients, central nervous system clinical studies offer a unique opportunity to access cutting-edge treatments before they become widely available. Participation in these trials not only provides potential benefits to individuals but also contributes to the broader scientific community’s understanding of CNS disorders. By participating, patients help shape the future of care for those living with neurological conditions.
The challenge of patient retention in central nervous system clinical trials
Just like in every clinical trial, patient retention is key to ensuring the success of research studies and the development of new treatments. However, when it comes to central nervous system disorders, maintaining patient engagement throughout a clinical trial presents unique challenges.
CNS disorders, such as Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis, often involve complex and long-term treatment regimens. These conditions may require patients to commit to regular appointments, frequent visits to study sites, and participation in lengthy follow-up procedures. For individuals with advanced or progressive symptoms, this can be a significant burden, particularly when managing symptoms and quality of life becomes more difficult over time.
Additionally, many participants in central nervous system clinical studies may have limited mobility, which can make travel to centralised study sites a physical and logistical challenge. Rural areas, in particular, pose an added complication, as patients may be located far from clinical trial locations, increasing the difficulty and costs associated with participation.
These burdens on patients often result in higher patient dropout rates, inconsistent participation, and challenges in collecting the data necessary to draw reliable conclusions about the treatment’s efficacy. From a clinical studies perspective, these challenges come with heavy financial costs due to having to recruit more patients and other causes of trial delays.
Improving patient engagement and retention in clinical trials
To overcome the burdens patients face and improve engagement, decentralised and hybrid clinical trials are providing more accessible ways to conduct clinical trials. These innovative approaches are transforming the way clinical research is conducted, particularly for patients dealing with complex conditions like central nervous system disorders.
Hybrid clinical studies combine traditional site-based research with decentralised methods, such as home visits, telemedicine, and mobile health technologies. This flexible design allows for a mix of in-person and remote interactions, giving patients the convenience of participating in clinical trials without the need for frequent travel to central study sites.
These approaches are especially beneficial for patients with CNS disorders, where mobility can be compromised, and travelling long distances for site visits can be a significant obstacle. Many CNS conditions can cause physical limitations that make regular travel difficult or even impossible. Decentralised and hybrid trials remove these barriers, providing an opportunity for patients to stay engaged in the trial by participating from the comfort of their own homes and reducing the strain of travelling.
As a result, these trial designs are improving retention rates, as they offer a more patient-centric approach that minimises disruptions to daily life and makes participation more feasible.
How mdgroup supports central nervous system research
At mdgroup, we are ensuring medically complex, high-care patients have access to life-changing treatments, by expanding the adoption of hybrid and decentralised clinical trial solutions around the world.
Our patient-focused approach ensures patients feel supported at every stage of the trial. This includes offering everything the trial and patient needs – whether that’s facilitating clinical trial participation within their own homes, supporting them to travel safely to and from study sites, or developing a hybrid model.
mdgroup doesn’t only help ease the burden on CNS patients but also creates a more inclusive environment for people who might otherwise be unable to participate in clinical trials due to different challenges. With our comprehensive approach, we achieve happier patients, decreased dropouts, and higher recruitment rates – ultimately contributing to the advancement of research and better treatment options for those living with CNS disorders.
We always go above and beyond to support patients in the way that works best for them and their lives. And that’s exactly what we did in a complex clinical trial, developing medicines for rare central nervous system disorders. We were contracted to deliver the highest level and quality of support to patients and their carers during the trial – easing the burden of participation from rural locations and ensuring the highest possible retention and engagement rate.
What were the challenges and the solution? Read the full case study here.
The future of clinical research in advancing central nervous system treatments
As research into central nervous system disorders continues to evolve, clinical trials remain a crucial avenue for discovering new treatments and therapies. At mdgroup, we are proud to support hybrid and decentralised central nervous system clinical studies that put patient needs at the forefront. By maximising patient retention and creating an environment of trust and support, we help bring new treatments to market faster, improving outcomes for patients with CNS disorders.
