The use of digital health technologies in clinical trials has increased considerably during the last few years, partly to the popularity of wearables such as Apple watches and Fitbit devices, in addition to the many over-the-counter devices and sensors.

In 2000, only eight clinical trials used digital health technologies to assist the trial; however, by 2017, the numbers had increased to 1,100 trials[1]. It has been estimated that by 2025, 70% of clinical trials will incorporate digital sensors[2].

In 2020, the COVID-19 pandemic has further forced adoption of digital health technologies in the healthcare and pharmaceutical industries to protect participant safety and enable clinical trial continuity[3]. 

Modernising clinical trials

Real-world data is information captured as a “by-product of everyday patient care”, and it can be collected from different sources, such as electronic health records, patient registries, wearables, and the sensors in smartphones[6]. 

Some of the most common digital health technologies adopted by pharmaceutical companies for clinical trials fall into several categories[3]:

• Telemedicine
• Electronic informed consent (eConsent)
• Digital data collection tools
• Remote site monitoring
• Direct to patient shipping (DtP)
• Medication reminders

Besides accelerating and simplifying the clinical trial process, these tools help automate the quantity, quality, and frequency of data collection. 

When implemented together, digital solutions have the potential to do the following[3]:

• Recruit a more geographically diverse participant population.
• Ensure trial product availability for participants.
• Reduce the burden of clinical trial participation.
• Reduce the number of essential personnel needed at the study site.
• Automate the collection of data while maintaining levels of quality for submission to health authorities.
• Improve the efficiency of clinical trials leading to better decisions and reduced timelines.
• Further advance the concept of risk-based approaches, focusing on the critical study elements that have been stated via health authorities and the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use’s Good Clinical Practice standards.
• Synthesise real-world evidence (RWE) and digital biomarkers which could be more responsive to change, increasing the possibility of real-time decision-making and benefiting patients enrolled in trials.

There is also an opportunity for greater efficiency by establishing interoperability of EDC systems, electronic health records (EHRs), and digital data collection tools to reduce the amount of source data verification (SDV) required by study monitors. This would mean that a more significant portion of the data could be accessed and reviewed without human transcription and a minimum risk of misinterpretation[3].

Incorporating these technologies into clinical research at every phase opens the possibility for reduced timelines and cost savings. Consequently, it is expected that companies willing to invest in digital technologies may win market share, while those who fall behind may find themselves at a disadvantage[5]. 

consumer readiness 

Digital technologies are embraced by people of all ages, in fact, a 2019 report conducted by Provision Living, a senior living community in the U.S.,  revealed that on average, Baby Boomers (born between 1946 and 1964) and millennials (born between 1981 and 1995) spend on average, five hours a day on their smartphones.

A survey conducted by Rock Health revealed that:

• 44% of the respondents tracked a health indicator using a digital tool in 2019, an increase from only 33% in 2017.
• 56% of the respondents shared health tracking data with their physicians in 2019, in comparison to only 46% in 2017.

Monsenso as a companion device, that supports medical compliance

Monsenso is a digital health technology that enables secure real-world data collection and behavioural data tracking via a smartphone app for users/patients and a web portal for clinicians/investigators. The solution is technically and clinically validated, and it can help improve outcomes on clinical trials. 

To learn more about the different clinical studies and clinical trials that have included the Monsenso mHealth solution, visit our Resource Library.

References:

1. 1. Marra, C., Chen, J.L., Coravos, A. et al. Quantifying the use of connected digital products in clinical research. npj Digit. Med. 3, 50 (2020).
   2. Jansen, Y. and Thornton, G. (2020) Wearables & Big Data In Clinical Trials — Where Do We Stand? Clinical Leader 
   3. Beyond COVID-19: Modernizing Clinical Trial Conduct
   4. Steedman, Mark, et al. (2020). Ten years on: Measuring the return from pharmaceutical innovation 2109. Deloitte Centre for Health Solutions.
   5. Digital endpoints whitepaper. Navigating the shift from traditional trial models to agile, patient-centric processes driven by digital health technologies.
   6. Real-world data: how can it improve clinical trial outcomes?