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Written in collaboration with Will Goddard, UK Managing Director at Big Health.
Digital therapeutics - evidence-based interventions driven by software to prevent, manage, or treat a medical condition - have the potential to revolutionize healthcare delivery worldwide. They break the traditional healthcare delivery paradigm by using mobile applications, web-based platforms, or other digital means to give patients faster, more convenient access to high-quality therapeutic content, with use cases across indications within virtually all therapeutic areas. In 2023, this unique family of health interventions was valued at $6.85 billion USD on a global scale, and is projected to reach $44.58 billion by 2033.
Despite growing acceptance of digital therapeutics as a way of delivering care, many companies are questioning whether to pursue FDA clearance in the US, NICE recommendation in the UK, or international equivalents to market their products. Some have opted to instead market as general wellness products, foregoing the rigors of evaluation and the need to conduct robust clinical and real-world trials to demonstrate safety and effectiveness. This practice raises significant concerns about evidence standards for these products, diminishing their credibility in effectively preventing, managing, and treating medical conditions. If anybody can simply develop an app and claim it is a digital therapeutic, without having the necessary evidence and the approval of a regulatory body to back it up, how can we have any confidence in safety and efficacy for its intended use population?
The answer is simple: we can’t. You wouldn’t expect a doctor to recommend a treatment that might be safe, or that might be effective. You’d expect them to be sure, with evidence to prove it. Why should it be any different with a treatment delivered digitally?
In order to differentiate these products from general health and wellness applications – which may improve overall well-being, but have not proven they are fit to prevent, manage, or treat a medical condition – digital health products must be held to the same level of scrutiny as pharmaceuticals, with gold-standard evidence.
There are a multitude of reasons why digital health companies today are choosing to forego the rigorous process for regulatory approval, including: anti-research sentiment; wariness of investors; and the desire for rapid market entry.
The growing anti-research sentiment within the digital therapeutics industry stems from a perception that traditional research and regulatory pathways are cumbersome and slow. Maintaining internal staff to manage research can be challenging, as many companies in this space are new to the process of running clinical trials, and outsourcing study management activities to contract research organizations (CROs) can be extremely expensive. This sentiment is further fueled by high-profile failures and perceived limited upside in the regulatory approval process, leading to a reluctance to invest in evidence generation.
Some investors, cautious of the financial risks associated with high-profile failures in digital health, are pushing companies away from the evidence generation necessary for FDA clearance. The digital health landscape is littered with examples of promising technologies that failed to deliver on their initial hype, resulting in significant financial losses. While this may in fact be due to companies’ lack of experience in running clinical trials in this space, it has led to a conservative investment approach, where the perceived limited upside of rigorous evidence generation does not justify the risks.
In an industry where speed can be a critical competitive advantage, digital health companies are tempted to bypass the traditional research processes to gain early market traction. Traditional FDA approval processes are lengthy and time-consuming, often taking several years largely due to its novelty. This approach, however, raises urgent concerns about patient safety and value for money. Products with no evidence to prove they are safe and effective simply should not be offered to patients seeking treatment for a medical condition. Moreover, products without evidence of safety and effectiveness will not be able to robustly demonstrate cost effectiveness for healthcare systems, either.
Lowering evidence standards in digital therapeutics could lead to a "death spiral" for the industry. Trust, once lost, is hard to regain. If digital health companies prioritize quick market entry over robust evidence, the entire industry risks being perceived as unreliable and unsafe. By bypassing the processes of obtaining FDA clearance, sponsors can’t obtain the clinical validation needed to differentiate their digital health treatments from general health and wellness products. Without the safeguards of operating under the FDA’s guidance, they also can’t guarantee their products are safe and effective for their intended use populations. This could erode the trust of both healthcare providers and patients, ultimately stalling the adoption of digital health solutions at a critical time when healthcare systems are increasingly reliant on digital as a means to deliver clinical-grade care at far greater scale than is possible through traditional, person-delivered means alone.
Despite the challenges, many digital health companies still see the importance in generating robust evidence and pursuing clearance from regulatory bodies like the FDA to prove - to patients, healthcare providers, and healthcare systems alike - that their products actually work and are safe to use. For example, just recently, Big Health obtained FDA clearance for its digital therapeutic, SleepioRx for insomnia, building on the positive NICE recommendation it obtained in 2022.
To build a robust, thriving, high-value digital therapeutics industry that upholds high evidence standards on par with the pharma industry, a multifaceted approach is needed.
Investors and life sciences stakeholders need to recognize that many promising digital health products will, when tested in robust clinical trials, fail to deliver the results hoped for. This is a routine part of the innovation process and does not mean that the entire modality is worthless. Just as we accept that less than 10% of drugs make it through clinical trials, so too must we accept that some digital products will not make it to market. Abandoning evidence generation because of the fear of failure is shortsighted.
Running clinical trials for digital health products requires a shift in mindset and methodology. Leveraging adaptive trial designs, digital endpoints, real-world evidence, and decentralized clinical trial (DCT) approaches can make the process more efficient and cost-effective for small-scale innovators who lack the deep pockets of pharma companies.
Treatment is treatment – it’s as simple as that. Whether delivered via a pill, injectable, app, or online platform, all health interventions must meet rigorous evidence standards. Removing the word 'digital' from the equation, we must ask if we would be comfortable with a treatment that lacks peer-reviewed evidence or has questionable safety. Trust is hard to earn and easy to lose, especially in healthcare. Rapid digitization of healthcare systems necessitates maintaining high standards to prioritize and protect patient safety and trust.
Evidence is the cornerstone of modern medicine, and that isn’t going to change just because we now have the ability to deliver treatment digitally. Digital health companies will need to embrace evidence and regulatory approvals if they truly want to make a difference in healthcare.
With strategic approaches to evidence generation and a commitment to maintaining high standards, the industry can balance the desire to innovate rapidly with the need to ensure patient safety at all times - ultimately building trust in digital therapeutics as a novel class of rigorously tested interventions that are just as safe and effective as traditional pharmaceuticals and devices.
Will Goddard is UK Managing Director at Big Health, the digital therapeutics company that builds treatments for the world's most common mental health conditions. Big Health's treatment Sleepio (for insomnia) is the world's first-ever digital therapeutic recommended by NICE and cleared by the FDA. Big Health's treatment portfolio also includes Daylight (for generalized anxiety disorder) and Spark (for depression).
