How to Start DTx Clinical Trials with DCT Technology

Conducting clinical trials to test the safety and efficacy of treatments can feel daunting for emerging DTx companies. DTx trials must overcome different challenges than traditional trials, such as incorporating wearables, collecting data remotely, designing novel endpoints, and submitting approval applications to regulatory bodies unfamiliar with their treatments.

The good news is that the hardest part of conducting a DTx clinical trial is getting started. By investing time and energy into design and leaning into support from partners with decentralized clinical trial (DCT) technology, DTx companies move closer to completing this important step to treatment approval and commercialization.

5 tips for starting your DTx clinical trial?

DTx companies collecting data remotely (e.g., wearables, digital patient surveys, electronic consent) will need DCT technology. Planning with this technology in mind will ensure its success for sites, sponsors, regulatory agencies, and participants. Consider the following when planning a DTx clinical trial:

Plan early, partner up to avoid common pitfalls

DTx companies may struggle with missing data sets, meeting recruitment goals, or proving treatment efficacy. Prepare by clearly defining digital endpoints and objectives before starting the trial and using systems with real-time data monitoring to catch discrepancies before jeopardizing results. This is especially important for DTx trials that require participants to do complicated or extensive tasks.?

Also, using DCT tools like electronic consent (eConsent) for recruitment will streamline the process for participants and staff and extend the reach of your efforts. Partnering with DCT tech providers with the tools to help mitigate these challenges is critical in early planning.

Frictionless systems for capturing and accessing remote data

Wearables and integrated devices can enrich datasets and offer new opportunities to measure how participants respond to treatment. They help researchers see how treatments work in the real world, away from clinics and amidst the stresses of daily life. DCT tools like electronic data capture (EDC) systems equipped with integrations like application programming interfaces (APIs) ensure data flows smoothly from wearables and integrated devices to a secure, centralized platform for analysis.

Interoperability key to using DCT in DTx trials

The existing technology used by many DTx companies provides a unique advantage to incorporating DCT technology. Unlike medical devices or pharmaceuticals, many DTx treatments rely on software. Not only will researchers have experience navigating technology, but participants will also be more open to using technology during the trial. Introducing digital tools may be simpler when the expectations and skills are already in place.

However, choosing the right DCT technology is crucial for DTx companies. Tools must fit seamlessly into existing software. For example, DCT technology teams can program results collected from electronic patient-reported outcomes (ePROs) to appear automatically in participant and researcher portals. No transferring data from one software service to another, freeing researchers to do other tasks and decreasing the chance for transcription errors.

Increasing diversity of data through DCT & targeted outreach

Collecting data from diverse participants is critical to ensure trial results are generalizable to broader patient populations. DCT technology like eConsent fosters better engagement and removes barriers to participation, such as travel time and cost or concerns over in-person visits. Engaging community organizations, like churches and community centers, also helps reach populations that may not be active on typical marketing channels, like social media.

Preparing for the future with a flexible mindset

Tracking a massive amount of real-world evidence from wearables and integrated devices means researchers may discover new implications for their treatments while analyzing results. A flexible mindset allows DTx to deal with unexpected results and pivot easily when challenges appear mid-study. There is no way to anticipate every challenge before it begins, but careful preparation and flexibility can ensure the trial will continue and not fail when hiccups occur.

Don’t be afraid to start

Launching clinical trials for a novel DTx treatment can be intimidating. The stakes are high; the risks are many. However, sometimes, the biggest barrier to creating an evidence base is getting past the starting line. By preparing, relying on outside expertise, and not overcomplicating the process, DTx startups can feel confident launching their first clinical trial.

Interested in more tips on using DCT tech in DTx clinical trials? Check out our blog article, Don’t Overengineer It: Hybrid Designs Overcome Barriers in DTx Clinical Trials, for additional insights from the DTx East panel discussion.?