Category: Articles

The cost of bringing a new drug to market is doubling approximately every 9 years [1]. However, this doesn’t mean we’re becoming less efficient with drug development. Several factors are contributing to this:

a – Clinical trials are increasing in size and complexity, while drug regulations have become more stringent.

b – Drugs must objectively outperform their predecessors. Complex diseases like Parkinson’s, Alzheimer’s or Rare Diseases require a greater allocation of resources, with higher levels of uncertainty.

c – Our understanding of multifactorial diseases remains incomplete. Addressing these challenges requires the adoption of new methods and practices that may lead to breakthroughs and pave the way for a better life for individuals living with these conditions.

At Beats Medical, we can support our partners to pave the way for improved outcomes for individuals. Our platform provides a variety of precision digital assessments and individualised digital therapies from four distinct modules: Gross Motor, Fine Motor, Speech and Wellbeing. Our investments in developing innovative technological methods have been recognised over the past 8 years. Using commercial mobile technology in the context of clinical trials is growing and has the potential to revolutionise the landscape of new discoveries, making the process faster, frictionless, and more cost-effective for companies. On the other hand, participants can rapidly connect without disrupting their daily lives, consequently reducing the problem of high dropout rates.

Timed Up and Go: An Established Approach for Measuring Mobility Changes

The Timed Up and Go (TUG) is a widely recognised clinical assessment tool used to evaluate mobility and balance in older adults or individuals with mobility impairments. This assessment is adopted as an endpoint in several clinical trials. It involves measuring the time it takes for an individual to stand up from a chair with armrests, walk 3 meters (10 feet), turn around, walk back, and sit down again. The TUG test provides valuable information about functional mobility, fall risk, and changes in mobility over time [2]. Traditionally, it is conducted in a clinical or healthcare setting, with a healthcare professional instructing the individual to perform the task as quickly and safely as possible. The time taken to complete the test is recorded for assessment purposes.

Beats Medical: Digitising the TUG Test

Under our gross motor module, we have made a breakthrough in how we deliver the TUG test. A digital TUG eliminates the necessity for a physical setup, while offering more precise measurements of movement, balance and gait parameters. This diminishes the dependence on subjective observations and enhances the accuracy of assessments, leading to a deeper comprehension of conditions affecting individuals with impaired mobility.

At Beats Medical, we recognised the potential of a digitised Timed Up and Go early on and developed an algorithm that captures measurements from mobile phone sensors across Apple and Android’s technology, with no additional hardware or sensors required.

During a TUG, the user is instructed by their phone to set up a chair with armrests against a wall, measure a distance of 3 meters (10 feet) from the chair, and place the phone in their pocket to initiate the assessment. Subsequently, the user receives audio instructions to guide them through the several Timed Up and Go stages in a standardised manner:

1. Sit-to-stand
2. Walk-out
3. Turn-around
4. Walk-in
5. Stand-to-sit

Demonstrating the Robustness and Adaptability of our Technology

In one experiment involving healthy subjects, we conducted tests using both Android and iOS devices. Each subject consistently placed the device in the same pocket for standardised conditions and was video recorded for further analysis by our research team. When comparing the total duration from stage 1 (sit-to-stand) to stage 5 (stand-to-sit) with the video recordings, the TUG algorithm demonstrated a Pearson correlation of 0.96, harmonised between both iOS and Android platforms (Pearson correlations range from –1, indicating completely opposite datasets, to +1, indicating identical datasets).

Another experiment involved individuals with Parkinson’s disease, between Hoehn and Yahr stages I-III and in their on-time, where medication is working and symptoms are controlled. Multiple TUG tests were conducted, following the exact approach outlined in the previous experiment. The TUG algorithm demonstrated a Pearson correlation of 0.99, harmonised between both iOS and Android platforms.

The results of both experiments were conclusive, demonstrating the robustness and adaptability of our technology across various scenarios, ranging from healthy individuals to those who experience mobility impairments due to a CNS condition. This adaptability allows our partners to adopt such a solution to address the specific needs of studies and clinical trials. 

Read more about how we partner with leading pharmaceutical companies here.

Timed Up and Go: An Assessment for Measuring Mobility Changes 

Beats Medical’s digitised Timed Up and Go offers valuable insights into gait patterns and potential digital biomarkers, laying the foundation for surpassing traditional tests in terms of accuracy, convenience, and cost-effectiveness with commercial mobile technology. Individuals can now comfortably conduct this test from their homes while experiencing a sense of engagement, trust and support, thereby furnishing researchers with detailed insights into their distinct mobility challenges. 

The TUG test has proven to be an applicable research tool in populations such as those with Parkinson’s disease, Multiple Sclerosis, hip fractures, Alzheimer’s disease, cerebrovascular accidents (CVA), total knee replacements (TKR), total hip replacements (THR), and Huntington’s disease. A study published in 2022 revealed that the TUG test can even serve as a robust predictor of mortality, outperforming established risk factors, including chronic diseases, in low- and middle-income geriatric populations [3]. 

Similar to the 2MWT, there are currently no other commercially available mobile solutions capable of providing a comprehensive and detailed analysis of gait changes throughout the TUG test’s five stages. This underscores the potential of Beats Medical’s digital TUG as a “lens” for companies to gain a better understanding of complex and multifactorial conditions, ultimately paving the way for improving the lives of individuals who experience mobility impairments. 

We invite you to join us on this exciting journey as we redefine the future of clinical trials and work together to improve patient outcomes in CNS and rare conditions.

For more information about how we can support your clinical trial pipeline visit our Partners page below, or reach out to andrew@beatsmedical.com.

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References

[1] Scannell, J., Blanckley, A., Boldon, H. et al. Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov 11, 191–200 (2012). https://doi.org/10.1038/nrd3681

[2] Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Physical therapy. 2000 Sep 1;80(9):896-903.Available from:https://academic.oup.com/ptj/article/80/9/896/2842520

[3] Ascencio EJ, Cieza-Gómez GD, Carrillo-Larco RM, Ortiz PJ. Timed up and go test predicts mortality in older adults in Peru: a population-based cohort study. BMC geriatrics. 2022 Dec;22(1):1-3.

Within the sphere of cutting-edge technology, leaders like Android and Apple are recognised for their advancements in biometric sensors for the general populace. However, a noticeable gap emerges when it comes to biometrics within clinical contexts.

Thorough internal testing by Beats Medical, in collaboration with users of our Parkinson’s application has demonstrated that, in comparison to the current state-of-the-art technology, our proprietary algorithms exhibit substantially higher levels of accuracy in tracking step counts for individuals living with CNS conditions.

Through our patented sensor adaptations and algorithms, Beats Medical outperform state-of-the-art technology in the measurement of altered movement and speech patterns seen in CNS Conditions and Rare Disease.

In direct contrast to the 83.8% and 90.6% accuracy rates achieved by industry giants Android and Apple when capturing steps taken by CNS patients (compared to clinician-monitored counts), our algorithmic technology achieved remarkable accuracy rates of 97.9% and 97.5% on Android and Apple devices, respectively.

This marginal error ensures that our users’ step counts align closely with the gold-standard of measurement, allowing us to attain exceptionally precise data and next-level insights.

Similarly, research conducted by Trinity College Dublin, a renowned national university, on our digitized 2-Minute Walk Test (2MWT) compared to the gold-standard clinician-administered assessment showcases a very strong positive correlation.

One of the most widely used statistical ways to show similarities between two data sets is through Pearson correlations. Pearson correlations range from -1 (indicating completely opposite datasets) to +1 (indicating identical datasets). The data comparing our digitised 2MWT to the traditional clinician-administered assessment has yielded a Pearson correlation of 0.98.

This speaks volumes about the remarkable proximity that our patented technology reaches in comparison to gold-standard practice measures.

The significance of more precise data cannot be overstated. It serves as the cornerstone for informed decision-making, thereby culminating in sharper insights and better patient outcomes. Specifically, the improved accuracy of biometric data improves our awareness of disease progression while fostering a deeper understanding of treatment efficacy— which in turn can help to shape more personalised treatment.

In clinical trials, the benefits are many, ranging from enhancing the recruitment and patient identification process to generating better quality data for analysis. Moreover, with accurate data being generated through a smartphone with no additional hardware or sensors required, the potential for generating real-world evidence is elevated to new heights.

For more information about how we can support your clinical trial pipeline, reach out to andrew@beatsmedical.com.

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Central Nervous System (CNS) drugs in Phase 2 and 3 clinical trials have a high failure rate, reaching up to 85%, second only to oncology [1]. The cost per failure in this space is estimated at $1 billion, a substantial cost borne by pharmaceutical companies. Most importantly, such failures impact people living with CNS conditions, who await breakthroughs and new treatment options. 

Given the urgent demand for drugs to address multifactorial neurodegenerative challenges and the potential impact of orphan drugs targeting rare conditions, it is crucial that we assess the challenges associated with trial execution that often result in unfavourable outcomes:

a – Trial failure can be linked to an inadequate study design, where endpoints rely on subjective reports from participants and observations made by clinical investigators [1]. 

b – David Reese, Amgen’s Executive Vice President of R&D, emphasises the limited understanding of neurological disorders and the complex development requirements for drugs in this field [2]. 

c – Additionally, participant engagement is a significant issue, with over 80% encountering challenges in retention. One in every five clinical trials is prematurely terminated due to a decline in participant numbers [3]. 

Trial failure not only denies patients access to much-needed treatments, but also adds to the overall cost of the failed trial, previous trials, and the missed opportunity of pursuing viable alternatives. 

For the last 8 years, Beats Medical have addressed these challenges, defining the following hypotheses: 

– Will the decentralisation of various aspects of a study or clinical trial considerably alleviate the burden on patients and, consequently, enhance participant retention and reduce overall trial costs?

– Will a digital platform, tailored to the person with the condition, deeply enhance our understanding of constantly evolving symptoms?

Optimising Clinical Trial Outcomes 

The COVID-19 pandemic has expedited the adoption of technology and improved digital literacy among patients. While it is assumed that remote trials alleviate the logistical burden on participants, some have reported difficulties, suggesting the presence of “digital overload” [3]. Embracing technologies familiar to participants, such as BYOD (bring your own device), can help alleviate some of these challenges by reducing the feeling of being inexperienced and the fear of failure [4] [5]. The recent first eCOA Forum examined the requirements and benefits for sponsors to explore through a BYOD setup [6].

Simultaneously, it is becoming increasingly evident that remote trials can provide reliable and intentional data collection from real-world settings. By embracing digital platforms, companies can tap into the potential of gathering highly detailed data that surpasses the limitations of in-clinic methods.

At Beats Medical, we like to describe this shift as a move “to measure in millimetres, not meters” leveraging commercial smartphones, their sensors capabilities and Beats Medical’s trained Artificial Intelligence (AI) models.

Beats Medical has developed a tailored platform for pharmaceutical companies to:

1 – Avoid the upfront costs of building a platform from scratch, easily accommodate growth and adapt to changing market needs, based on their digital health strategy.

2 – Define objective endpoints and build a deeper understanding of the conditions being researched, while defining their strategy for future commercialisation of breakthrough therapeutic programs.

3 – Differentiate from other competitors in the market by providing a unique commercialised product under their own brand that delivers added value to their customers; utilise it to conduct studies and devise their strategy around it that can combine drugs with digital intervention.

Our platform can be deployed to target the most common symptoms of any central nervous system condition or rare disease, such as walking, hand movements and speech.

We ensure consistent and dependable results through the standardisation of supported digital assessments, namely electronic Patient-Reported Outcome Measures (ePROMs). They are delivered to the user’s mobile device, whether it be Google’s Android or Apple’s iOS, with no additional hardware required. The most common symptoms can be evaluated with a range of assessments, digitised with a market-leading level of precision, including:

• Walking: Timed Up & Go, 2-minute walk test, 6-minute walk test, timed 25-foot walk

• Hand movement: 9 Hole Peg Test, Spiral Hand Drawing and others

• Speech: Sustained Vowel Phonation, Breath Control and others

• Surveys and Wellbeing

Given the diverse range of smartphone capabilities, Beats Medical have developed algorithms, enhanced by AI, to ensure consistent and precise data collection across all supported iOS and Android devices. Throughout our research process, we discovered that individuals with impaired walking may not find the iOS and Android platforms reliable. We worked relentlessly to overcome this limitation, to ensure our technology delivers dependable outcomes for these populations. We established a comprehensive validation process that incorporates a series of tests for each measurement conducted. This involves real-world observations using video recordings, usability testing and recording visual elements displayed on the screen to ensure consistency across all devices.

Remarkably, our technology, which is built on top of the existing Apple and Google offerings, has exceeded their standard measurements by achieving an impressive 97.5% accuracy in detecting steps for individuals with impaired walking. By harnessing the capabilities of Beats Medical’s platform, companies conducting studies can acquire a comprehensive understanding of the multifaceted aspects of a disease. Our platform empowers researchers to delve deeper into the complexities of various conditions, enabling them to make well-informed decisions backed by precise and reliable data.

Enhancing Patient Experiences 

To address retention and engagement challenges, we have placed our focus on driving behavioural change and enhancing the user experience by capitalising on the devices and patterns that individuals are already familiar with. Participants want to consume health-related technology in the same way they already consume their favourite digital products. This approach has produced remarkable outcomes, notably a 102% increase in physical activity among our CNS users over a 14-month duration.

Furthermore, we have achieved an impressive 70% retention rate over a 12-month period, ensuring reliable data collection and sustained commitment from participants throughout each study. These advancements pave the way for faster and more efficient clinical trials, significantly reducing the likelihood of prematurely terminated studies caused by a decline in participant numbers. 

Joining Forces for Unlocking New Therapies

The digital revolution has ushered in a new era for clinical trials and therapies, offering transformative solutions to the challenges faced by the pharmaceutical industry, particularly concerning the limited understanding of multifactorial neurological and rare disorders.  

The platform’s advanced capabilities require no additional hardware other than a smartphone, providing pharmaceutical companies with the tools to navigate various phases of the process, from real-world data collection to the successful commercialisation of novel therapies.

We firmly believe that technology is the essential driver required to accompany this journey, enabling companies to demonstrate efficacy, obtain regulatory approval, reduce costs, and engage patients effectively. By embracing a unique approach, companies can enhance the likelihood of achieving new and innovative solutions for patients, ensuring greater success in their treatments. 

Our long-term vision for our partners also includes the validation of the digital biomarkers of the future. These biomarkers hold tremendous potential to provide unparalleled insights into the emergence and progression of diseases. By harnessing the power of digital assessments and biomarkers, supported by AI, companies can unlock new avenues for revenue generation, expedite time-to-market, and explore opportunities to diversify their product portfolio. 

In future articles, we will delve into how digital assessments, such as ePROMs, can serve as intelligent lenses for comprehending complex diseases and accelerating breakthroughs in drug development. 

We invite you to join us on this exciting journey as we redefine the future of clinical trials and work together to improve patient outcomes in CNS and rare conditions. 

To learn more about our innovative platform and explore partnership opportunities, visit beatsmedical.com or reach out to andrew@beatsmedical.com. 

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References

[1] WCG – CNS Trial Failure Rates High As Need for New Drugs Grows. https://www.wcgclinical.com/insights/cns-trial-failure-rates-high-as-need-for-new-drugs-grows/ 

[2] Global Business Reports – United States Biopharmaceuticals 2020 – https://www.gbreports.com/files/pdf/_2020/US_Pharma_2020_-_Web_Version.pdf 

[3] Digital Therapeutics and Decentralized Trials: A Match Made in Clinical – https://www.appliedclinicaltrialsonline.com/view/digital-therapeutics-and-decentralized-trials-a-match-made-in-clinical 

[4] Donnelly S, Reginatto B, Kearns O, et al. The burden of a remote trial in a nursing home setting: qualitative study. J Med Internet Res. 2018; 20(6):e220.

[5] Coyle, J, Rogers, A, Copland, R, De Paoli, G, MacDonald, TM, Mackenzie, IS, et al. Learning from remote decentralised clinical trial experiences: a qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders. Br J Clin Pharmacol. (2022) 88:1031–42. doi: 10.1111/bcp.15003

[6] The First eCOA Forum Examines BYOD and Item Skipping – https://www.appliedclinicaltrialsonline.com/view/the-first-ecoa-forum-examines-byod-and-item-skipping

Neurological disorders can affect up to 1 billion people worldwide [1], while rare diseases more than 300 million people [2], often resulting in unmanaged symptoms and inadequate care. These disorders have a significant impact on the independence and quality of life of patients, as well as on healthcare systems.

Currently, the total healthcare costs for all services provided (i.e., medication, preventive services, etc.) for neurological disorders reached $1.2 trillion, surpassing the combined cost of heart diseases, cancer, and diabetes [3]. 

There is an urgent need to find effective therapies and conduct successful clinical trials. Meanwhile, the pharmaceutical industry faces challenges in patient engagement, logistics management, and the 85% failure rate of CNS drug trials [4].

It has become evident that a different approach is necessary to better understand these conditions. A solution that embraces remote trials and utilises digital assessments, such as electronic patient-reported outcome measures (ePROMs), can offer pharmaceutical companies improved patient engagement, enhanced data collection (“measure in millimeters, not meters”), reduced site costs, and increased reliability and objectivity in results.

Furthermore, it will empower patients to independently manage their symptoms, complements specialist care with accessible technology, and provides valuable data insights for informed healthcare decision-making. 

Digital assessments: a paradigm shift 

Beats Medical has pioneered a groundbreaking digital platform that harnesses the power of precise assessments through patients’ smartphones, empowered by Artificial Intelligence (AI).  

What sets our platform apart is its exceptional ability to detect subtle changes in movement and speech patterns, surpassing traditional methods and establishing a new standard for assessing patients with CNS and rare conditions. By utilising commercially available smartphones that patients are already familiar with, our platform enables ePROMs to be conveniently conducted from the comfort of their homes, offering unparalleled precision compared to traditional methods.

Furthermore, it can be tailored to accommodate objective primary and secondary endpoints of any study or clinical trial, incorporating existing or expanded assessments related to walking, hand movement, and speech. This approach, with the support of AI, facilitates a better understanding of the disorders being investigated throughout the various phases of a clinical trial, informing the future commercialisation of a breakthrough therapy.

Our platform encompasses user-friendly Apple iOS and Android applications that allow patients to effortlessly complete daily walk tests (such as the Timed Up & Go or 2-minute walk test), speech tests (including Sustained Vowel Phonation or Breath Control), hand movement tests (such as the 9 Hole Peg Test or Spiral Hand Drawing), and many others that can be adapted to suit the specific conditions being investigated. Empowered by AI, these tests act as specialised ‘lenses,’ enabling pharmaceutical companies and researchers to delve deeper into specific disorders and gather invaluable data about potential biomarkers and future therapies.

In a series of upcoming articles, we will delve into the advanced capabilities of Beats Medical’s platform and the subsequent benefits it can offer as a standalone solution or when integrated with existing drug portfolios. This integration adds value to patients and companies across the different stages of a clinical trial, leading up to future commercialisation.

We invite you to join us on this exciting journey as we redefine the future of clinical trials and work together to improve patient outcomes in CNS and rare conditions. 

To learn more about our innovative platform and explore partnership opportunities, visit beatsmedical.com or reach out to andrew@beatsmedical.com.

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