January 16, 2020

HealthXL Report: Clinical Trials Optimization with Digital Health

Chandana Fitzgerald

We started our conversations on the digital opportunity for clinical trials at the HealthXL Global Gathering in September 2019. And after many months of exchanges, debates and conversation, our long awaited report on Clinical Trial Optimization is finally here! 

Why is this important? Some stats and facts. 

The People 

Our Q1 report is completely expert led, oozing with opinions from the catalysts of the industry including: 

Clincial Trials Report Contirbutors
Report Contributors

Key Takeaways 

What is the real future for digital in clinical trials? Has digital made clinical trials cheaper and faster? Has regulation changed to support these ‘new age’ trials? Do we understand what digital signals correspond to clinical end points? These questions have inspired this HealthXL report on Clinical Trial Optimization. We explore the hype vs reality of this opportunity under 5 key themes that were handpicked by HealthXL members. Below we summarize our key takeaways: 

Can Digital Strategies improve Clinical Trial Recruitment and Retention? 

Digital is helping pharma reach new cohorts of patients where they share their stories: online. It is also enabling pharma to co-create new strategies with healthcare providers that allow patients to partake in trials from their homes. However, it is too early to prove that a full online-only engagement modality will dramatically increase patient enrollment into clinical trials or retain patients in clinical trials. We also want to steer away from the use of the word ‘siteless’ trial and promote the use of ‘decentralized’ or ‘virtual’ trial. 

Can Digital Health Lower Costs of Clinical Trials? 

We believe technology will enable ‘cost shifting’ rather than gross cost reduction, by helping to better manage the cost of routine tasks and logistics. This may lead to new business models or additional profits based on expanded data collection. Short term cost escalation will yield longer term benefits.

Will Digital Health Expand Clinical Endpoints for Clinical Trials? 

Even if we lack best practices at this moment in time, digital biomarkers allow for continuous collection of real-world patient data in clinical trials. We are attempting to understand what digital biomarkers are, and which ones can be captured for various indications, and through what devices. 

Who is Driving the Changes to Regulation Necessary to Adopt Digital Tools in Clinical Trials? 

We believe that pharma, consortia of pharma (e.g. Neuroscience Consortium) and digital health innovators will lead the way through R&D and piloting. 

What Areas are Ripe for Optimization with Digital Health? 

Much hope has been placed on the utilization of digital health technologies to manage and treat chronic conditions. Cardiometabolic conditions are regarded as one area ripe for disruption due to the high burden as well as large populations impacted along with many devices aimed at that sector currently. Pharma is increasingly interested in how similar offerings could be expanded towards more high risk and rare conditions in neurology and oncology.

Therapy areas: Cardiology, Oncology, and Neurology

Clinical Trial Pathway: Recruitment, Retention, Logistics 

Grounded in Data and Evidence

We’ve identified 119 (and counting) start-ups working to optimize clinical trials along the pathway (protocol design and review, patient recruitment, site selection, patient engagement, data collection, as well as operational management and risk monitoring) to help reach the promise of faster, cheaper, better. We have also picked out ongoing studies, pilots and initiatives already in play to make tech enabled trial optimization a reality. 

Sample clinical studies that are currently collecting and measuring digital endpoints
Users can explore all company data at:  https://portal-beta.healthxl.com/  Not yet a HealthXL Platform user? Request Access here:   https://portal-beta.healthxl.com/request-access 

Next Steps: Our Future Expectations 

Do you have experience leveraging digital solutions to improve clinical trials? Are you a PI looking to identify an appropriate digital solution to help you overcome an investigation challenge? Do you agree/disagree with our findings?We’d love to hear from you, and of your initiatives in translating hype to pragmatic reality. 

Are you a HealthXL Member? See the Full Report Here

Non-HealthXL Member? You can purchase the report HERE

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