Can you imagine a world without being connected? The era of technology has swept through society and influenced almost every facet of our daily lives. Digital technology has become a powerful catalyst worldwide as it continues to drive sustainable growth and inject itself into various countries, industries, and networks. By 2025, the digital health market will be worth more than half a trillion dollars as startups continue to rise.1 This is creating profound excitement for the future of healthcare as it takes on a more prominent role. The emergence of digital therapeutics has received immense recognition as it focuses on enhancing our lives by providing accessible and convenient products and services to influence our overall well-being.

What are digital therapeutics?

You may be familiar with health and wellness apps that are accessible via your mobile phone or tablet. Digital therapeutics are the next level up as they are evidence-based software designed to redefine the way we manage and treat various health conditions by either supporting or replacing traditional drug treatments.2 This intuitive approach uses electronics, like a smartphone, to deliver treatment anywhere at any time.3 There are many diseases with unmet needs, such as schizophrenia, multiple sclerosis and chronic insomnia, that can benefit from treatment models such as digital therapeutics.4 Like all therapeutic products which are investigated through clinical trials, digital therapeutics would have to undergo an approval process by review boards prior to entering the market (for example, the Food and Drug Administration in the USA). One advantage of digital treatments is that these apps can collect real-world data frequently and seamlessly throughout the treatment, thereby minimizing the burden experienced by patients. With this real-time data, patients and their physicians can quickly assess personalized treatment plans on a case-by-case basis.5 This nascent digital health industry is surely an innovative approach towards the archaic clinical trials currently in place.

How will it benefit and challenge the existing industry?

Clinical trials are expensive to run and there is no guarantee that the investigative product will ever reach the market as every piece will be placed under scrutiny by regulatory authorities, such as the FDA. The approval process through regulatory bodies may end up being faster for digital therapeutics.6 However, it will be a challenge to develop a standard regulatory process that fits all emerging tech products in the digital health spectra, such as wearables, telemedicine and electronic patient-reported outcomes.7 The study design, study requirements, and endpoints for each product will differ from the current regulation placed for traditional clinical trials.8 The pursuit to enhance clinical trial experience will be cumbersome as the process is quite rigid; by committing to continuously assess how digital health can impact patients and their families will serve as a reminder for all of us in the health and pharmaceutical industry what is at stake here—the opportunity to improve a patient’s quality of life by creating easy access, reducing treatment discontinuation and ultimately increasing patient adherence.

Why is it important for the patient?

Time and time again, we learn that one of the biggest challenges for patients participating in a clinical trial is the burden of attending frequent follow-up visits, and then once they arrive, the extended wait times. From practicing cognitive behaviour therapy to following up on a patient’s adherence to the treatment, digital therapeutics can apply artificial intelligence to promote the well-being of each patient. Physicians can discern a patient’s non-compliance and address the issue in an agile manner based on real-time feedback and monitoring from digital therapeutics. The ability to collect data and merge all analysis into one framework will create a more efficient environment for the physician and patient.9 Attracting a patient to a clinical study that involves artificial intelligence is one objective; however, thorough engagement throughout the study will increase the chances of retaining the patient as they will feel more involved and important.10

As the digital market continues to emerge, digital therapeutics will play a vital role in the digital health pipeline. When digital therapeutics are prescribed with traditional prescription medication, it can better address and tackle the full burden of the disease.11 Digital therapeutics will allow the patient to have increased communication with the physician at their convenience, while also giving the physician the opportunity to review real-time data and respond to the patient’s needs.

Stay tuned for Part II of this series!

By Nadeen Hamdanieh, Account Associate

References

1,3,4,5,11STAT, “Realizing the promise of prescription digital therapeutics”, 2019. [Online]. Available: https://www.statnews.com/2019/10/29/prescription-digital-therapeutics-realizing-promise/. [Accessed 06 Dec 2020]

2CMAJ News, “How “digital therapeutics” differ from traditional health and wellness apps”, 2019. [Online]. Available: https://cmajnews.com/2019/10/10/how-digital-therapeutics-differ-from-traditional-health-and-wellness-apps/. [Accessed 06 Dec 2020]

6Nature, “The emerging world of digital therapeutics”, 2019. [Online]. Available: https://www.nature.com/articles/d41586-019-02873-1. [Accessed 06 Dec 2020]

7,8,9MedCity News, “What are the challenges and opportunities of running clinical trials of digital therapeutics?”, 2019. [Online]. Available: https://medcitynews.com/2019/09/presentation-highlights-challenges-and-opportunities-in-digital-therapeutics-clinical-trials/?rf=1. [Accessed 06 Dec 2020]

10Applied Clinical Trials, “What Patient Centricity Means to a Patient”,  2017. [Online]. Available: http://www.appliedclinicaltrialsonline.com/what-patient-centricity-means-patient. [Accessed 06 Dec 2020]

Wanson, Robert. “Digital Health Wearables”. 14 May 2017. Online image. Flickr. 13 January 2020. https://www.flickr.com/photos/155752310@N05/46292833265/.