The HealthXL team has returned to Dublin from Gothenburg following yet another successful Global Gathering, this time in collaboration with AstraZeneca. The day-long event focused on the topic of ‘It Works! Tech in Clinical Trials’ and the various ways in which digital measures are currently deployed in pharmaceutical drug development. As is typical with our Global Gatherings, the two-part agenda contained thought provoking presentations from experts and trailblazers in the digital R&D space, before engaging participants in roundtable discussions for the afternoon. 

We first heard from Jennifer Goldsack (CEO, DiME) about the progress of digital measures in clinical trials, before learning about the Mobilise-D consortium’s journey to regulatory qualification presented by Giorgio Davico, PhD. Case studies were presented by Christine Guo, CSO at Actigraph and Caroline Jonstrand, Global Study Lead at AstraZeneca.

Roundtable discussions dominated the afternoon agenda, with conversations focused on value drivers as well as validation and regulatory requirements for digital measures in clinical trials. Three key takeaways emerged from the group discussions:

1. Digital measures have multiple efficiency drivers: The use of digital biomarkers and endpoints in clinical development presents several value drivers; these include efficiency drivers, improved patient experience, and the ability to capture previously unmeasurable aspects of health and well-being. Engaging patients, healthcare providers, and payers is essential for successful buy-in. Furthermore, addressing the concerns of key stakeholders will be crucial for building trust and promoting the acceptance of digital measures. 

2. Patient centricity includes focusing on digital touchpoints in their treatment journey: To gain support from patients, it is paramount to offer measures that are valuable in their daily lives, optimise treatment, and improve their understanding of their condition. Healthcare providers prefer measures that are familiar and easy to capture using mobile phones and unobtrusive sensors. Payors value objective, frequently collected, and long-term data provided by digital measures, which can lead to value-based contracts. Involving payors in discussions and collaborations builds trust and helps with adoption of digital measures. 

3. Clarity and collaboration is required to advance digital measures in R&D: To advance digital measures in research and development, healthcare leaders must overcome challenges and seize opportunities. This involves addressing issues like terminology, ensuring correlation between digital and clinical measures, and validating and standardising technical aspects. These steps ensure that digital measures are reliable, accurate, and meaningful for patient care. By recognising the maturity of regulations and successful collaborations between pharmaceutical and digital health companies, healthcare leaders can explore innovative possibilities and drive transformative changes in healthcare delivery. 

The resounding consensus on the day was that tech in clinical trials will work. 

The groundwork is being laid as we speak. Some challenges are bigger than others but by tackling them one by one, while embracing opportunities, we will unlock the full potential of digital measures to improve patient outcomes and revolutionise the healthcare industry.

Thank you to all HealthXL members and friends who attended the event and contributed their insights and learnings on the day. As our Swedish hosts would say, tack och tills nästa gång (Thank you and until next time). See you all in Princeton, New Jersey on November 16th for our next Global Gathering. 

Read the full event report here.