The five principles at the heart of our inflammatory joint disease clinical trial program
Dr. George Vratsanos, rheumatologist and Executive Global Program Head at Novartis Pharmaceuticals, shares his team’s top five principles that are at the heart of our clinical trial program.
Nov 05, 2015
Rheumatologist Dr. George Vratsanos and his team will present findings from their research at the annual meeting of the American College of Rheumatology.
The team is working toward the development of a new biologic treatment for two disabling inflammatory joint conditions: ankylosing spondylitis and psoriatic arthritis.
Dr. Vratsanos and his team follow five guiding principles for ensuring clinical trial excellence.
Rheumatologist Dr. George Vratsanos leads an inspired team of people from all over the world who work on the global program at Novartis Pharmaceuticals for an exciting new biologic treatment. It is currently in development to address two disabling inflammatory joint conditions: ankylosing spondylitis (AS) and psoriatic arthritis (PsA).
This month, Dr. Vratsanos – the Executive Global Program Head for the new treatment – and his team will present findings from their research at the annual meeting of the American College of Rheumatology (ACR) in San Francisco, the largest meeting of its kind. This research is the result of a truly global clinical trial program comprising 23 clinical trials involving more than 4,000 patients in more than 40 countries.
Dr. Vratsanos and his team know what it takes to ensure that the data collected is both robust and meaningful for patients and doctors as well as regulatory authorities. Here are five guiding principles he and his team follow for ensuring clinical trial excellence, along with direct insights from Dr. Vratsanos:
1. Focus on patients
A successful clinical trial program is one that ultimately leads to the approval of a treatment that improves or even extends patients’ lives. Talking with patients to understand what they really need and building these insights into the trials are extremely important. “People living with these conditions have told us they are still plagued with pain and want us to ‘give them their lives back.’ So we built that insight into our trial program by introducing measurements that can answer these needs very directly – assessing daily function, pain and quality of life.”
2. Lead with the science
Use your understanding of a specific molecule or compound as your starting point for developing your research program. “We conceived the research program that we’re presenting at ACR because the science indicated to us that a specific molecule [interleukin 17A (IL-17A)] played a key role in the disease development and progression of AS and PsA.” Learn more about the role of IL-17A in inflammatory joint diseases.
3. Be courageous
If you want to develop a treatment that can dramatically change a patient’s life – not just a treatment that is a little bit better than what is currently available – you have to take risks. The team took these risks because they hoped IL-17A would show something no other biologic had ever shown before in treating AS and PsA, something that would address some of the needs that current treatments do not. “When we got the early data that suggested that the new treatment could potentially prevent joint and spine damage in PsA and AS, now that was a special moment. We all understood we had something really new and important in our hands.”
4. Collaborate with experts
Collaboration with experts is crucial at every stage of the development process. Top rheumatologists from around the world – the doctors who treat PsA and AS – were involved in the program from the beginning. “Involving experts at every stage of the process allows us to ensure that we are measuring the right things that will not only meet stringent health authority requirements, but will also capture those things that are most meaningful to patients and their physicians.”
5. Keep the patient as your inspiration
We are united by the common purpose to make this transformative new treatment available to patients as quickly as possible, and we are inspired to keep patients’ needs front and center. “The ability for patients to ‘get their lives back’ and have a normal quality of life are the things that matter most to patients – and therefore matter most to us too.”
Dr. Vratsanos and his research team are working to develop a treatment for people with AS. A common sign of AS is spinal inflammation causing pain and movement difficulties. If the disease continues to progress, the spine can eventually fuse, making even everyday tasks impossible.