Clinical Research
Providing accurate real-world evidence
for successful clinical trials
Designing new endpoints
to accelerate medical progress for mobility assessment
Developing treatments for neuromuscular and neurological disorders raises a challenge: collecting enough relevant data to provide reliable clinical outcome assessments while setting up a representative study cohort with enough volunteers.
Traditional clinical trials based on statistics and controlled environments can fail to provide variables representative of the efficacy of treatments because they may not accurately represent patients’ real capabilities due to short term variabilities (fatigue, motivation, context…).
Based on real-world data and continuous measurement, the Syde platform is able to create precise, meaningful, and representative endpoints that can be collected from fewer patients.
"Rare" is not so rare
More than 7,000
rare diseases
Less than 5 in 10,000
people suffer from a given rare disease
350 million
patients suffer from rare diseases
75%
of patients are children
Way too rare solutions
3,200
genes identified as responsible for rare diseases
95%
of rare diseases have no curative treatment
50%
of patients have no accurate diagnosis
Digital endpoints the future of clinical trials
While traditional clinical tests were created decades or even centuries ago, modern technology can provide more representative clinical outcome assessments of a therapy with continuous real-life data.
With leading institutions, patient associations, and healthcare professionals, Sysnav Healthcare has developed a proven capability to co-design digital endpoints that meet the requirements of clinical trials (objectivity, reliability, sensitivity to change, and clinical meaningfulness).
Thanks to Syde, SYSNAV Healthcare has become a recognized provider of real-world evidence for pivotal clinical trials.
SV95C: the only digital endpoint qualified by the EMA
In 2023, the Duchenne Muscular Dystrophy (DMD) Community achieved a significant milestone as the European Medicines Agency (EMA) officially validated SV95C (Stride Velocity 95th Centile) as a primary endpoint for superiority studies. This validation offers a valuable alternative to the 6 Minute Walking Test for evaluating ambulant DMD patients.
SV95C is the first regulatory-qualified real-world digital outcome measure for use as a primary endpoint in pivotal studies of Duchenne Muscular Dystrophy. It represents the top 5% fastest strides a patient spontaneously takes in their normal daily environment over a pre-defined time period. SV95C can be applied in therapeutic, confirmatory and natural history studies.
This recognition opens up new horizons, paving the way for the widespread adoption of digital endpoints as the primary evaluation criteria in clinical trials today and daily clinical care tomorrow.
Scientific Publications
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The 100-meter timed test: ability to detect change over time in DMD
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Longitudinal results of magneto-inertial motion analysis in DMD ambulant patients
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A Movement Monitor Based on Magneto-Inertial Sensors for Non-Ambulant Patients with DMD
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Investigation of the relation between the trunk and upper limb functions in DMD
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Longitudinal home-monitoring data in non-ambulant patients with Duchenne muscular atrophy
- Stride to height ratio as a new ambulatory outcome measure in DMD
- Use of a powered arm support devices for upper limb function in non-ambulatory men with DMD
- Kinematic/behavioural fingerprints in Duchenne muscular dystrophy and their clinical applications
- The Importance and use of Syde® wearable Technology and the Stride Velocity 95th Centile (SV95C) Endpoint in Duchenne muscular dystrophy
- Read our Poster presented at the 2024 MDA Clinical & Scientific Conference
Towards personalized medicine
Post-approval applications
Sysnav healthcare invests in R&D and technologies that produce, manage and analyze real-world data to drive major transformations in healthcare with individualized medical solutions that are more efficient and cost-effective.
Personalizing a treatment response for each patient is ultimately leading to a shift in the clinical treatment paradigm from a trial-and-error process to “the right drug, for the right patient, at the right time” approach.
With the Syde platform, SYSNAV Healthcare is offering stakeholders access to the data needed to adapt healthcare protocols and economic models and to put evidence of improved patient outcomes at the center of treatment. In the future, SYSNAV Healthcare will be extending Syde’s use in clinical trials, fueling phase 4 with precise and aggregated data.
