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Digital Endpoints in Clinical Trials for Neurology: Benefits and Impediments to Adoption

June 30, 2022Neelem Sheikh

In addition to the pandemic, the digitization of healthcare is rapidly shifting clinical trials from analog to hybrid or fully decentralized clinical trials, catalyzing the development and implementation of digital health technologies to support clinical research.

Digital endpoints not only support the decentralization of clinical trials but also provide a means to collect more sensitive, high-frequency data while reducing trial costs and improving overall efficiency. 

Below, we discuss the use of digital endpoints in clinical trials for neurology, highlighting the benefits and impediments to adoption.

Traditional vs. Digital Endpoints

The assessment of health and disease state requires a robust set of criteria to define health status, disease progression, and therapeutic response. These measurements are known as endpoints. In Alzheimer's disease clinical trials, for example, endpoints are utilized to measure and understand the therapeutic response to a drug or therapy. 

Digital endpoints differ from traditional endpoints in that they include the use of sensor-generated data that is often collected outside of a clinical setting during their normal Activities of Daily Living (ADLs). This data can be derived from body-worn sensors, integrated sensors in wearables and portables, and even ingestibles and embeddables. For example, an integrated inertial sensor in a smartphone can be used to measure gait, or a smartwatch can be used to measure blood oxygen levels and heart rate.

Benefits of Digital Endpoints in Clinical Trials

Digital endpoints have the potential to offer previously inaccessible accuracy and precision, provide new previously unattainable insights, and ultimately, reduce the cost of drug development

By using digital endpoints in clinical trials, both patients and pharmaceutical companies will see a breadth of benefits. Patients benefit from easier access to clinical trials and new therapies brought to the market more rapidly, while pharmaceutical companies benefit from more efficient and affordable trials. 

Efficient and Accurate Patient Screening

Subject screening and selection for neurological disease clinical trials is currently an incredibly costly and time-consuming process. Typically, subject screening relies on expensive imaging and diagnostic technologies. For example, to determine subject eligibility, many Alzheimer’s drug clinical trials require expensive positron emission (PET) scans or invasive cerebrospinal fluid analyses as a part of the key inclusion criteria to establish protein levels, such as beta-amyloid and tau

With thousands of potential subjects, the screening and selection process can drive clinical trial expenses through the roof. Digital endpoints, along with strong analytical tools, have the potential to be utilized to determine precisely where on the Alzheimer’s disease continuum a given patient lies. This method can serve as an initial tool to narrow down the subject pool, filtering out ineligible subjects before completing costly imaging or diagnostic procedures needed for key inclusion criteria. 

High-Frequency Monitoring

Currently, there are few tools available for efficient and accurate longitudinal monitoring of neurocognitive function. These assessments are only performed periodically throughout clinical trials and typically rely on a person to administer and score the assessment, introducing human-to-human variability. Additionally, normal day-to-day human variabilities within the test takers themselves can significantly bias assessment results. By utilizing digital endpoints, we not only gain more accurate, sensitive data but also benefit from a more detailed understanding of therapeutic response.

Improved Analysis of Therapeutic Response

Understanding at a highly granular level how an individual’s ADLs are changing is arguably the most compelling method for monitoring brain function in neurological disease patients. However, longitudinally assessing the effect of neurological disease-modifying drugs on clinical trial subjects is currently largely dependent on unreliable cognitive assessments that collect limited data on cognition and practically no data on function. These assessments often produce noisy, highly variable results that lack the specificity and granularity to reasonably conclude the efficacy of a drug or therapy, ultimately delaying the go/no-go decision. 

While traditional endpoints are still fundamental and necessary for trials, digital endpoints and digital biomarkers provide pharmaceutical companies with a scalable, affordable way to collect the granular, supplemental, and contextual information needed to arrive at a go/no-go decision confidently and efficiently.

Impediments to Digital Endpoint Adoption 

It is clear that digital endpoints offer benefits beyond overcoming the shortcomings of traditional endpoints. However, there are barriers to digital endpoint adoption that should be considered. 

  • The need for clinically significant data: Due to the high cost of clinical trial failures, many pharmaceutical companies are hesitant to change their process and incorporate digital endpoints. It is necessary to put in many years of research to ensure the digital endpoints produce clinically significant data.
  • Lack of international collaboration: International collaboration is a key factor for the successful adoption of digital endpoints. Sharing resources and collaborating at an international level will allow for more rapid development of the necessary body of evidence to support the use of digital endpoints in clinical trials. However, despite a unified vision for the use of digital endpoints in clinical trials, there is a lack of international collaboration and cooperation. 

While there are barriers, the benefits to patients and pharmaceutical companies greatly outweigh the efforts needed to support this adoption.

Altoida: Powering the Next Generation of Clinical Trials

At Altoida, we are building the world’s-first Precision Neurology platform and app-based medical device—backed by 11 years of clinical validation—to accelerate and improve drug development, neurological disease research, and patient care.

By completing a 10-minute series of augmented reality and motor activities designed to simulate complex ADLs on a smartphone or tablet, Altoida’s device extracts and provides robust measurements of neurocognitive function across 13 neurocognitive domains. Our device measures and analyzes nearly 800 multimodal cognitive and functional digital biomarkers. Through the collection of highly granular data from integrated smartphone or tablet sensors, Altoida’s device produces comprehensive neurocognitive domain scores. This data can be tracked longitudinally to reveal trends and patterns while flagging concerning ones.

Altoida is powering the next generation of clinical trials—our app-based medical device will provide pharmaceutical companies with the ability to increase the cost-efficiency, speed, and success of neurological disease clinical trials, from subject screening and monitoring to data analysis. Our Precision Neurology platform and app-based medical device provide:

  • Cost-effective subject screening: Altoida will enable reliable precision diagnosis for subject screening and selection, conserving the use of expensive imaging. Our device can be used as an initial tool to narrow down the subject pool, filtering out ineligible subjects, prior to completing imaging or diagnostic procedures necessary for key inclusion criteria.
  • A robust proxy for traditional endpoints: Altoida will serve as a robust proxy to traditional endpoints in neurological disease clinical trials, providing highly sensitive, generalizable longitudinal data. 
  • Infrastructure for decentralized clinical trials: Altoida’s robust digital test platform, equipped with a connected ecosystem for communication with patients and full study management, provides all necessary components for seamless virtual testing and monitoring as well as statistical data analysis.

To learn more about the digital endpoints in clinical trials or about utilizing Altoida’s Precision Neurology platform for neurological disease trials, contact us today.

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At Altoida, we use digital biomarkers to radically change the method of assessing brain health and cognitive diseases. After nearly two decades of research, we are developing a platform and device to measure and analyze cognitive biomarkers associated with cognitive impairment to evaluate perceptual and memory function.
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