Adding value for drug developers
At Aparito, we have rare disease and paediatric expert that have worked across the drug development life cycle. We work together with patient groups, key opinion leaders and drug developers in order to integrate our technology into the heart of drug development programmes, generating data to:
Identify meaningful outcome measures that can be used as endpoints in clinical trials. In rare diseases it is not always clear what is the “best” endpoint to use in a drug development programme, as this may well be the first drug to be developed for the indication. Regulators and companies often differ in their opinions on the most appropriate endpoints to use, whilst patients may have different opinions again about what is important to them. A good Natural History Study helps to identify the most appropriate measures for discussion with regulators, and support the most effective pivotal study design. Aparito technology allows patients to easily capture and record important disease-related events on a continuous basis, thereby defining the natural history of the disease.
Provide additional measures of drug effectiveness to supplement clinical endpoints in clinical trials. It may be that the selected clinical endpoints are very difficult to measure or interpret and an inconclusive trial result can be catastrophic for a development programme. Supplementing the clinical endpoint data with patient-generated data (including out of the hospital setting) may provide additional evidence of efficacy and safety & could even avoid the need for additional clinical trials, saving time and money. Aparito technology allows patients to easily record information about their disease over time and its effect on every aspect of their lives.
Provide a rich dataset for economic analysis of the impact of interventions on the patient pathway, to assist with post-approval market access. New treatments for rare diseases are often considerably more expensive than treatments for common conditions and it can be difficult to demonstrate the value of the treatment to payers, based only on clinical endpoint data from the trial programme. By generating data on how an intervention changes the patient pathway through the HealthCare system, aparito technology provides reliable information for economic analyses on the impact of the intervention.
Atom5™ is a digital platform designed for paediatric and rare disease remote patient monitoring. Data on digital biomarkers quantify how a patient feels, functions and responds to treatment with new outcome measures.
Accurate, complete, ‘real-world’ data, rather than a snapshot based on a hospital visit
Faster patient trial recruitment (particularly for geographically dispersed populations)
Improved patient engagement and retention thanks to less discomfort
Enhances passive monitoring capabilities
Improves timely access and avoids unnecessary trials
Lowers clinical trial costs
Improves regulatory compliance
Regulatory compliance is a key consideration in service design. The global platform operates under ISO 13485 and FDA Title 21 CFR part 11
Patient Reported Outcomes (PROs)
Being able to score the quality of life of patients during a study is critical in understanding a range of measures.
The PRO module of our technology is fully configurable and through our dashboard technology, tracks the actual patient outcome scores in addition to measuring each patient against the entire cohort.
Our technology also has personalised branching for response based data capture, making data capture more dynamic.
Each disease type brings its own challenges. The Events module is fully configurable and allows study sponsors to add a dimension of data capture that can often be correlated with other data points.
For example, it has been shown in one of our ongoing studies that a drop in physical activity for up to 24 hours occurs when a patient reports an actual, or near fall.
To understand how effective a treatment is, it is key to know if the patient is taking it.
The Aparito Medication Adherence module reminds the patient to follow the prescribed treatment protocol and tracks doses taken.
In current adult studies, individual patient engagement with this part of the system (minus reminders) is 70% on average.
Similar to tracking medication, it is important to know if patients are attending regular appointments with their HCP or if they have needed ad-hoc treatment at any time.
The Visits module provides the patient with a quick and easy way to report where they have been and why.
Select the wearables
The use of a wearable is at the centre of the technology. With an average compliance rate of 83% across an adult cohort, high degrees of patient engagement can be achieved, allowing the technology to deliver insight not previously available.
Using Atom5™ it is possible to monitor any number of data points. We can connect to any bluetooth device to record any data points that are important for your research.
Interpreting Results and Delivering Value
We support a wide range of reporting and analytic capabilities.
The real-time dashboard comes as standard with our core study system providing up-to-date patient and study wide indicators.
As your study progresses we can help formulate the questions you want to answer. We can do this by looking for patterns and correlation with our statisticians or we can use more sophisticated mechanism such as Machine Learning tools to conduct disease progression analysis when sufficient data has been collected.