Increasing medicine diversification with digital phenotyping and smart clinical trials

Highly targeted precision medicines promise better health outcomes, fewer side effects and less toxicity, but delivering this added value requires a robust and comprehensive business case. Digital phenotyping can provide the required insights by continually measuring and collecting health information from patients, providing a comprehensive picture of how they feel on a day-to-day basis.

In a recent interview, David Grolman, former president of the Australian Pharmaceutical medical and scientific Professionals Association, explained that historically, “doctors have diagnosed diseases such as hypertension or atrial fibrillation by single, intermittent measurements of blood pressure (BP) or electrocardiogram (ECGs). These conditions have highly variable features which are influenced by stress, diet, patient positioning, exercise, and even time of day.”

He proposes a more effective approach using “continuous ambulatory monitoring of physiological and metabolic parameters now possible through advanced sensors, internet transfer of data, unlimited data storage, and the computing power available.”

Unfortunately, many pharmaceutical companies are stymied by various limitations in the effort to leverage digital phenotyping. These limitations include difficulty identifying the right sensors to use, testing and integrating those sensors in existing infrastructures, and enabling asset management for sensors.

As a result, administration and coordination become time consuming and expensive. All the up-front costs must be incurred before any digital phenotyping program gets off the ground, and long before it delivers any measurable value-adds derived from real-world data.

Why traditional approaches don’t work

Healthcare and wellness is a huge driver of the high-tech industry, and there has been an explosion of start-ups working to develop increasingly sophisticated wearables and sensors.

With such a disparate and disorganized ecosystem of players, developing a business case and rolling out a thoroughly designed study protocol involving patients, data collection and interpretation can become unmanageable. In addition, continuous monitoring of digital sensors and wearables can result in massive datasets that defy clear interpretation, making it extremely difficult to demonstrate therapeutic value.

Adding to the complexity is the fact that these types of studies often last years and take place in patient homes, not clinics and hospitals. To make this a reality, it’s critical to:

• Ensure continuous monitoring is integrated into an overall service provision concept
• Effectively manage device software and hardware updates, repairs and service
• Control the study’s carbon footprint

Atos has substantial experience working with clients to overcome these and other challenges. Below, we will outline a sustainable, manageable approach that merges a global partner ecosystem with core clinical operations capabilities.

Creating a specialized approach

Managing these end-to-end requirements is very difficult within the constraints of a traditional pharma organization. So, how can we democratize digital phenotyping, increase medicine diversification and improve the overall therapy without a cost explosion?

This was exactly the question that Atos was asked by a top five global pharma company. It needed help identifying, selecting, testing and integrating a specialized sensor for monitoring autism. The objective of our first project was to identify and evaluate new technology solutions with the goal of developing new digital biomarkers in autism.

At a high level, our approach consisted of:

• Sensor scouting: Based on the study requirements and digital phenotyping objectives, we scout for specialized sensors by leveraging our global innovation centers and a large start-up ecosystem. We work closely with the sponsor team, evaluating critical success factors like usability, suitability, deployability, access to raw data and more. We also deliver input for study planning and execution, data collection and insights extraction. Our experts then consult and support study sponsors in developing protocols to thoroughly test the data quality of the chosen sensors to ensure that meaningful insights can be delivered. Ultimately, we provide a comprehensive evaluation and recommendation of the most appropriate solution to support the sponsor’s digital biomarker strategy.
• Sourcing and integration: Atos is heavily involved in all operations to source, test and integrate the sensors into the study infrastructure, including app and data lake development. We work with sponsors to source and build the study kit with all necessary components, including special instruments, wearables, mobile phones, apps, scanners, training material, etc. We also ensure the kit reaches each end user with our Study Kit Deployment service. Finally, we provide secure data collection and advanced data analytics and data science, defining and designing algorithms to support business and study objectives.
• End-to-end asset management: It’s critical to use the same hardware and software to capture data over the entire duration of the study, to ensure that the results are comparable. Accordingly, Atos provides a built-in platform management process for device provisioning and maintenance, as well as consistent software components across the complete study duration. To support all study stakeholders, we provide a service desk that supports patients, investigators and study teams worldwide. It takes all geographic requirements into account, operating seven days per week, supporting over 3 million users in 38 languages, and managing 3.2 million devices.

Adding measurable value to clinical studies

Since our first project a few years ago, we have tested and fine-tuned the process based on a growing number of projects with clients. Building on this initial concept, we have created a comprehensive solution that enables pharma companies to focus on the medical science — leaving Atos to manage the end-to-end process of identifying, selecting, integrating and monitoring sensor data.

Working with an ecosystem of specialized partners, we take care of scouting out specialized sensors (in any therapeutic area), capturing the specific requirements, and delivering a comprehensive evaluation and recommendation to support a new digital biomarker strategy.

Apart from a dramatically reduced administrative burden, our clients have realized benefits that include:

• 30% faster sensor-to-market, defined as the time from study requirements definition to having the digital phenotyping solution up and running
• A precise, qualified, and comprehensively documented sensor application, which proves data-driven health outcomes for individuals and supports precision medicine business cases
• Device and platform-agnostic solution integration, with the ability to quickly scale-up and avoid bottlenecks in staging, deploying and managing digital study kits

We believe that a similar approach will go a long way in delivering value to pharma companies, and new life-saving therapies to patients worldwide.

If you are interested in learning more about smart clinical trials, you can find additional information online at https://atos.net/en/portfolio/accelerating-clinical-trials-and-reducing-costs-with-digital-technologies.

Topics

• Industry Insights
• Health & Life Sciences
• Internet of Things & Edge
• cloud