I look forward to the Digital Therapeutics (DTx) East conference every year. Even though this year the conference took on an online-only format, it still created the opportunity for a slew of interesting conversations about digital health – a topic that COVID-19 has thrown into the spotlight.
As Head of Clinical at Fern Health, I had the opportunity to participate in a panel on the topic of virtual clinical trials and digital therapeutics. While there has always been some resistance to digital health from payers, pharma, and providers, the COVID-19 pandemic has pushed the industry to fast adoption of telemedicine and other digital health solutions out of necessity.
Now, it’s our responsibility to build clinical trials and research plans that validate these digital products for efficacy and patient usability, while creating a sustainable plan for their continued evolution.
Based on my experience bringing both digital and non-digital therapeutics to market, I have a few recommendations on how to build successful and impactful clinical trials for digital health products that I discussed on the panel:
1. Design a rigorous clinical and regulatory roadmap.
In order for a digital therapeutics to be taken seriously – and lead to clinically meaningful results – it’s critical to have a plan for how the product will be tested, benchmarked, and how it will evolve over time. There have been moments in my consulting experience when I’ve asked startups about their regulatory roadmap and received blank looks. Even feasibility studies are an important place to start, especially if you can map out an expansion plan for later down the line.
2. Include the patient voice in concrete ways.
For years, patient centricity has been a buzzword in the healthcare industry. When I’m analyzing an organization’s clinical trial design or product, I look for evidence that the team has done more than simply listen to requests and feedback from patients and caregivers. Have they also applied those viewpoints in practice? For example, in product development, it’s not enough to test the user interface and usability with patients – you have to also incorporate their preferences into your product design. In clinical protocol design, getting input from patients on feasibility is crucial. It doesn’t matter how efficacious a therapeutic might be, if patients won’t use them in the real world.
3. Develop endpoints that are meaningful for patients.
One concrete way to incorporate the patient voice is by identifying clinical trial endpoints that are meaningful to patients. For example, with the Fern digital chronic MSK pain platform, we’re shifting the focus of pain management from pain relief to functional restoration. Functional pain endpoints are more important to patients in the long term than pain relief alone.
4. Don’t fall into “analysis paralysis.”
In any digital health product, it’s easy to become bogged down in data. Instead, focus on generating actionable insights and evidence that answer key questions or help improve your product.
5. Know that regulatory approval isn’t the end-all, be-all of the research process.
As an industry, we need to shift the laser focus on regulatory approval as the ultimate validation, as the real value is found in the development journey. Health economic outcomes and human factor research are just as important, if not more so, than clinical efficacy, safety, and tolerability for product adoption.
Digital therapeutics, from clinical trials onward, create an opportunity to democratize access to both the research process and to high-quality care. Even though our work is digital, we must remain rooted in real-world function and outcomes if we want to create products that lead to meaningful outcomes for patients.
