Unmet needs in clinical tr ials for neurological conditions

NEUROLOGY

Dee Stoneman, Global Medical Head, Multiple Sclerosis at Novartis Pharmaceuticals discusses clinical trials for neurological conditions, such as multiple sclerosis (MS), and explores how they could be made more efficient

The impact of COVID-19 on clinical trials in neurology

Along with the rest of the industry, COVID-19 had a significant impact on clinical trials in neurological conditions. At Novartis UK, we had several interventional trials that were affected, and it meant we had to find completely new ways of operating. Whilst this was immensely challenging at the time, there were positives that came from this. We were forced to find new ways to keep things moving, look at our existing processes from a more innovative perspective and reevaluate the way we conduct clinical trials. For example, we completely reconsidered how we do Expanded Disability Status Scale, a common measure for MS.

While certain clinical trials were unfortunately put on hold, the silver lining of the pandemic was that we were able to make great strides towards more efficient processes and more accurate data, making long-term positive changes.

Improving the efficiency of clinical trials and bringing new treatments to patients

Now, we are including patients earlier on in the process and using their perspectives to bring more efficiencies to our clinical trials.

We’ve had experts from the patient community help us with recruitment and execution of trials, allowing us to understand the patient point of view much earlier on in the process rather than waiting until it’s too late to make the necessary changes. What we will continue to see moving forward is patients bringing their knowledge and perspectives into the early stages of clinical trials, as the pandemic has really lowered that barrier and allowed us to test those boundaries.

There have also been opportunities for trials in countries that normally wouldn’t have been feasible – this is another advantage of things being increasingly virtual. This new virtual world has become incredibly efficient, speeding up processes and advancing new technology in clinical trials.

There is a lot of value in bringing different viewpoints forward as much as possible, laying the groundwork for a faster and more efficient trial in the long run.

The importance of diversity in neurological clinical trials

There’s absolutely no doubt on the importance of diversity in developing clinical trials, particularly for neurological conditions.

There’s an interesting project in Switzerland, The Women’s Brain Project, which is generating evidence to understand the impact of sex and gender differences in neurological conditions: in the neuroscience space, it’s very clear that there are differences.

These differences aren’t just between different sexes – that’s why it’s important to have as much diversity as possible in each clinical trial. For example, if we were to look at the diversity of ethnicities with MS, there are wide-ranging incidents, particularly as there is a combination of genetic and environmental factors at play.

However, often what we see in clinical trials, and then in real life, are not the same due to an absence of diversity, and it’s our goal to bring these two results closer by producing more accurate clinical data. We know there are no better candidates to test your treatment on than those who’ll take it in the future. Patients should be able to ask their doctor, ‘how did this drug affect people like me?’ and have access to the clinical data to answer their questions.

We are committed, as part of our Health Inequalities Pledge, to strengthening patient inclusion in clinical research so that patients from all backgrounds have the opportunity to participate.

The challenges of building clinical trials for MS and developing new treatments

Huge progress has been made so far, and new, innovative treatments are at the heart of this. One of the biggest challenges we face when bringing a new treatment to market is how best to design the clinical trial, and how to show the incremental benefit of the treatment to patients. There is also a great amount of choice with the number of treatments we currently have available, so running trials in different countries is difficult because there could be other treatments that are already the preference. That’s why it’s really important to design innovative trials, whereby if a patient is on a treatment that’s proving to be less efficacious, their exposure to that treatment is limited, if possible, and they are moved onto the more effective treatment as soon as the trial allows. MS is a lifelong chronic condition, but early disease control could help to provide patients with a better quality of life in the longer term.

Recruiting patients for trials despite existing treatments

Taking part in trials in the UK has always been very attractive for patients, as they involve regular health checks and blood tests, and many patients appreciate the additional monitoring of their health that is necessary during trials. The MS community as a whole has seen how new treatments have really made a difference to patients, so they’re especially receptive to clinical trials for new advancements. They’re a very engaged patient community, and are very knowledgeable about trials, which gives us a great opportunity to work together. As well as this, despite existing treatments already making a huge difference to patients, we still don’t know what’s driving disease progression. Really learning about this is what will make the biggest difference to people with MS.

The future of MS treatments

The biggest revelation over the last five to ten years was the understanding of the role of B cells in MS; MS was always previously thought of as a T cell-driven disease. There’s a lot more scope for studying B cells in the future, to really learn more about how MS evolves or develops.

Secondly, MS is a therapy area where there aren’t a lot of combination treatments, so that’s also something that may be explored more in the future. Lastly, I’m excited to see how we address disease progression and make positive improvements to the lives of those living with MS.

Dee Stoneman is currently Global Medical Head, Multiple Sclerosis, Neuroscience Therapy Area, based in the global headquarters of Novartis in Basel, Switzerland. She oversees its MS portfolio of existing and pipeline assets from a medical affairs perspective.

A UK registered pharmacist by background, Dee has spent over 20 years in the pharmaceutical industry, with the last 15 of those spent in medical affairs roles. She has worked in several therapy areas in that time but with a deep focus in neuroscience. Having worked in local and global roles, interacting with many different healthcare systems, Dee believes strongly in the importance of collaboration across the health ecosystem, to bring forward medical advances that benefit patients no matter where they are or what their situation may be.

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