Clinical Trial mHealth Update: an EU Perspective

The biopharmaceutical industry continues to explore how mHealth can change clinical trials, as the discussion continued at Hanson Wade’s mHealth for Clinical Trials EU Summit in London. Topics included challenges and expectations in digital health, hindrances impacting digital health adoption in clinical trials, and further defining patient centricity and decentralized trials. Hanson Wade’s, IMPAACT mHealth Summit is occurring in Boston 10-12 July, 2018.

Challenges and Needs of Digital Health

While digital health is widely adopted in consumer markets, clinical researchers have different expectations with the use of digital devices in clinical trial settings. Daragh Ryan, Clinical Trials Technology Consultant at Actelion Pharmaceuticals, suggested there are gaps in current digital health devices for clinical trial implementation. Ryan indicated that researchers want connected devices that integrate seamlessly, have multiple remote sensors to capture objective data and clinical endpoints, and are validated and are medical grade to support regulatory submissions. However, Ryan elaborated that researchers experience something different; digital health devices exhibit limited connectivity options and provide no feedback into device and patient status, they have low bandwidth, demand higher frequency raw data and high power consumption which requires more patient support, higher patient burden, manual data uploads, and expensive data contracts with vendors. Moreover digital health devices from numerous vendors require integration and data synchronization, which adds to complexity, cost, and security concerns. Ryan predicts that future technologies will have better connectivity (i.e., Bluetooth 5 and 5 G network connectivity), enhanced sensors and expanded sensor measurement types (i.e., activity, gait speed, respiratory rate, e.g., SB 02, heart rate), and longer battery/charging solutions.

Why Aren’t Clinical Trials Digital Yet?

Clinical trials are notoriously known to be a laggard when it comes to innovation due to the strict regulatory environment in which they operate and ensuring patient safety. In addition, there isn’t much regulatory guidance on implementing digital health in clinical trials, and there are few validated digital health measures. According to Alistair Stuart, Director of Clinical Projects & Digital Platforms at GSK, digital health pilots are occurring in healthcare settings, however, they are experimental and episodic. While digital health in healthcare is paving the way for clinical trials, sponsors and CROs are not fully implementing digital health because the regulatory framework is still evolving, and data is siloed in a variety of databases, making data access and aggregation a challenge. Additionally, Stuart explains that vendor feasibility processes at sponsors are not aligned with novel technologies; for example, current due diligence is often conducted on PowerPoint presentations or paper, forcing study teams to take big risks with unproven technology pilots, while attempting to deliver on their study’s objectives and endpoints. The process can be improved if it evaluates vendor business activities with critical success factors in clinical trials and enables teams to conduct head-to-head comparisons with other vendors.

What Will it Take to Drive Digital Health in Clinical Trials?

So, what will it take to drive digital transformation? According to Kai Langel, Director of Clinical Innovation at Janssen, several factors will drive change. From the patient’s perspective, driving forces include the centralization of many study procedures around the patient. For example, patients will have access to online doctors/nurses, home visits, community clinics and general practitioners, and apps and wearable technology will empower data collection. Additionally, continuous measurement of patient satisfaction via surveys throughout the trial can enhance the clinical trial experience and patient engagement, as sites can intervene if patient satisfaction levels drop beneath a key performance indicator. Langel believes that clinical trial data quality, time and costs, reducing site burden, and enhancing oversight, will drive digital innovation from Sponsors.

Defining Decentralized Trials

There have been several explanations for patient centricity and decentralized trials, as some have suggested hybrid models. Bryan McDowell, Global Program Lead, Digital Development at Novartis, helped clarify the definition of decentralized clinical trials by conferring that they are executed with patients spending some or most of their time outside of sites when conducting study visit procedures. To achieve decentralized trials, study teams need to develop protocols more efficiently through protocol feasibility networks, execute consenting through eICF, leverage eSource to electronically capture study data, use connected sensors and novel endpoints, and deploy ePROs and patient engagement tools to enhance adherence and the clinical trial experience.

Summary

In summary, digital health still has a long way to go before the clinical trials industry adopts these solutions. Inadequate regulatory frameworks, lacking validation requirements, poor industry feasibility preparedness for evaluating digital health vendors, and concerns with digital health device measurement capabilities, data security and operational issues contribute towards hesitancy in adopting digital health. However, it is only a matter of time before regulatory agencies, digital health devices, and the biopharmaceutical industry evolve to accommodate digital health in clinical trials. 

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.