Digital therapeutics (DTx) companies have big questions to answer when designing clinical trials—how to engage diverse populations, bridge gaps in the digital divide, and incorporate usable data from wearables, to name a few. At DTx East 2023, Castor’s Head of Solutions, Kristen Harnack, joined the “Challenges and Solutions in Conducting Clinical Trials for Digital Therapeutics” panel to unpack these issues and discuss solutions.
The panelists from Big Health, Philips Pharma Solutions, HelloBetter, and Castor highlighted key solution takeaways, including careful trial planning at the outset, the importance of a flexible mindset for the full trial team, and an acceptance of tools that help operations. Kristen may have said it best, “We see a lot of people get in trouble because they add lofty things they want, [which extends] their timelines and overcomplicates what could have been simpler. Don’t overengineer it.”
Here are some major themes from the panel discussion:
Overcoming risk-aversion is the first step to DCT adoption
The session began by discussing wearables and integrated devices in DTx clinical trials. Decentralized clinical trials (DCT) technology can capture data from the remote sources many DTx companies use to deliver care outside of a traditional clinical setting. DCT technology can capture the real-world effectiveness of treatments, offering exciting opportunities for enriching datasets and reaching new populations.
The panel noted that in some cases, trial sponsors and research sites worry that adopting DCT technology will jeopardize efficiency or complicate regulatory approval. When the stakes are high and the process is already complex, the choice is often to avoid the uncertainty of investing in something new and stick with traditional methods. This risk-averse approach is a major barrier DTx must overcome to take full advantage of DCT technology.
Raising awareness of the benefits of DCT technology, working to find ways to standardize data, and advocating for improved regulatory approval processes can all increase DCT adoption. The first step to gathering evidence through a clinical trial using DCT technology is to find the right partners and prepare thoroughly.
“It’s not rocket science to build out an evidence base, but you need to have the right people on board with the right expertise […] You need to make sure you partner up with the right organizations but also be prepared to develop your own standing in this case, you need enough money, enough time, room for error.“
– Elena Heber, Co-Founder and Chief Clinical Officer, HelloBetter
Setting up DCT technology early improves DTx trial timelines
Despite the risk-averse environment, DCT technology is gaining traction in DTx clinical trials. Now that DCT technology has been used for several years by early- and mid-adopters, its benefits are becoming apparent for DTx companies still on the fence (or looking in from the outside).
Panelists explained that as recognition of the benefits of DCT technology rises, more DTx companies are willing to use it in their trials. DCT technology is a natural starting place for DTx clinical trials (compared with pharmaceutical or medical device clinical trials) because many DTx treatments already rely on technology.
For example, integrating DCT technology like electronic consent (eConsent) seamlessly with existing software helps reduce trial timelines. Kristen also noted that Castor has seen recent eConsent successes with “… 17,000 patients enrolled in [one] trial in 15 weeks” and highlighted that these continued successes will only add to the recognition of DCT technology.
“If you have your development program set up properly, your phase three can leverage phase one in terms of devices and decentralization. But you have to set that up early. That’s the bottom-up approach we need.“
– Tim Callahan, VP of Scientific Affairs, Phillips Pharma Solutions
Hybrid trials help reach diverse populations
Panelists discussed the importance of including diverse populations in DTx clinical trials so that results are not biased towards certain groups and the challenges of ensuring enrollment representative of varied race, gender, and socioeconomic statuses.
The consensus was that increasing diversity in clinical trials is a nuanced matter that requires early planning, conscious effort, and investing time and resources into learning how to reach underserved communities. As Elena Heber puts it, “Diversity in clinical trials doesn’t just happen. We all need to be aware that it needs a conscious effort to make that happen.”
Community involvement is critical to improving participant diversity because establishing trust and relationships with underserved populations happens at the ground level and often in person. This fact seems at odds with DCT technology and DTx treatments, which are often remote and require personal devices, technological know-how, and internet access. How can digital tools be implemented at a personal level, especially in areas with varied socioeconomic populations?
The answer is a hybrid approach—involving both influential community organizations and efficient, user-friendly DCT technology.
“Any trial can be a hybrid trial. You can get the benefits of both. Having local organizations involved, who are going out to churches and community centers, and they have a relationship and they have a reputation with the community. Allowing them to use those technologies to reach those people more efficiently.“
– Kristen Harnack, Director of Solutions Counseling, Castor
Last thoughts from DTx East:
- DTx clinical trials may struggle with missing data and recruiting enough participants – some of these challenges may be mitigated with advanced planning, adoption of DCT and eConsent to support reaching more varied audiences and ensuring a flexible mindset of the full study team
- Wearables present exciting possibilities for real-world evidence of a treatment’s effectiveness
- The importance of well-defined objectives and endpoints when starting DTx clinical trials is key to success for both sponsors and, more importantly, patients
- DTx manufacturers can set new industry precedents with approaches that reduce costs and shorten timelines to tackle complexities of regulatory involvement in DTx clinical trials
- Flexibility, continual growth, and awareness of the efficacy of processes during clinical trials are imperative in early planning stages.
- DTx companies should be prepared, not afraid, to conduct clinical trials and lean into available technology like DCT, eConsent, electronic patient-reported outcomes (ePRO), and others to create a more dynamic, personalized trial.
Castor’s product suite seamlessly integrates with DTx technology to collect data during clinical trials. Our ongoing work to simplify workflow for trial participants and site staff keeps Castor software poised to meet the unique needs of DTx companies just starting clinical trials. Book a demo with our team to learn more!