This past month, 109 of our HealthXL community members met across 12 meetings to discuss digital measures in clinical trials, clinical and economic outcomes for RPM and DTx last mile delivery, among other topics. We’ve put together a snapshot of 5 expert insights from these meetings.

#1 On the role of digital tech for trial recruitment and retention: Issues with recruitment and retention of clinical trial participants are obvious in numbers. Digital tools can be useful on many occasions, some examples: to enroll patients from different geographies, improve patient awareness on clinical trials they can participate in, reduce the burden of participating in a clinical trial, reduce biases from a health equity perspective, reach a greater number of patients for large studies, etc. Digital solutions can also help across the ecosystem of clinical trials. When talking to pharma, they are more open to digital tools for recruitment and retention compared to other areas like digital biomarkers. However, they are still risk averse, which is a huge barrier. There is less resistance from pharma when the digital tech component doesn’t lead to big changes in their protocols. 

#2 On digital health solutions for cancer patients: Patient support is key to improve Quality of Life (QoL). Aside from the disease itself, oncology patients deal with mental health issues and side effects that compromise their QoL. Digital health solutions are working to tackle these pain points, however, solutions truly focused on QoL and those that help care teams better manage their patients are still lacking. 

#3 On DTx and Pharma partnerships: Before a DTx company approaches pharma, they need to understand the specific pharma company they want to work with, their needs and their roadmap. This is important because there may be a fit now, but not in the future plan. We are still in the early days and pharma companies are experimenting with different business models. At the end of the day, there needs to be a strategic fit with the patient pain points pharma has identified. DTx solutions will be relevant for pharma companies if they: 

• Help with the diagnosis of the disease they are treating i.e. identifying more patients
• Improve drug adherence
• Help to treat more patients (extended indications) 
• Or provide data to understand how their drug and competitors are being used. 

#4 On common misconceptions about SaMD regulation in the US: Three common misconceptions about SaMD regulation in the US include: 

Misconception: New guidance(s) dramatically deviate from established regulatory principles and practices. 

Truth: Generally, most new guidance presents processes and interpretation consistent with established frameworks. 

Misconception: Hardware is easily separated from software.

Truth: Any hardware customization to support device use (e.g. customer sensors, configurations, processors, etc.) prevent a product from being SaMD. 

Misconception: New programs/guidance creates significant reduction in Time-to-Market (TTM) for SaMD devices. 

Truth: Available data shows TTM for most types of submissions remains relatively stable. 

#5 On clinical and economic outcomes for RPM: We have seen some convincing studies showing that by using something as simple as ePROs, we can actually improve clinical outcomes. As generating the evidence from RPM tools can take a lot of time and resources, there are many RPM companies referring to those studies when talking about their clinical evidence. In terms of economic outcomes, only by keeping patients on their pills will RPM programs save money for health systems and pharma conducting RCTs. A lot of payers and health systems think about reducing costs in the short term, hence, if companies can’t prove savings in the short term, it will be harder to get buy-in. 

Want to join the conversation? Check out our website for upcoming meetings and events. 

Interested in more expert insights and takeaways? Become a member of our HealthXL Community for access to polls and summaries from all of our meetings.