Key takeaways from our recent meeting 'Incorporating Digital Measurement Technologies in Clinical Trials: Challenges & Best Practices'
Poll Results
The use of digital measurements in clinical trials has many possibilities. What are the most challenging use cases at the moment?
• 21.4 %
Digital measurement as primary endpoints
• 21.4 %
Secondary endpoints
• 14.3 %
Exploratory endpoints
• 7.1 %
Other
• 7.1 %
Support in the definition of the inclusion/exclusion criteria
• 14.3 %
Support in the definition of the treatment allocation arms
• 7.1 %
Support dose selection
• 7.1 %
Don't know
From the following, what is more challenging when incorporating digital measurement technologies into clinical trials?
• 22.2 %
Lack of standardization and lack of awareness of current standards like DiMe’s
• 22.2 %
Measures not being solid enough to prove efficacy and/or safety
• 16.7 %
Selecting the right measurement and technology
• 5.6 %
Changes needed in the sponsor’s operational processes
• 16.7 %
Principal investigator education
• 11.1 %
Additional regulatory requirements
• 5.6 %
Patient education on how to use the tool
Due to the novelty of digital measurement technologies, most stakeholders (sponsors, principal investigators, patients) don’t have a full understanding of how to use them in a clinical trial
• 100 %
Agree
What are the biggest barriers that prevent you/your team from incorporating digital measurement technologies into clinical trials?
• 23.1 %
Internal legal/regulatory teams
• 15.4 %
Willingness of Clinical Ops teams
• 23.1 %
Regional regulators/regulations
• 30.8 %
Lack of validation/standards
• 7.7 %
Internal IT teams (cyber security, compliance, etc.)
Key Takeaways
- Bringing regulators on board is a huge barrier to the adoption of digital measurements in clinical trials. Even though they understand the digital measure and find it interesting, they still want to see the traditional measure they are used to. Hence, most digital measures in clinical trials are currently exploratory. On the flip side, patients, hospitals, PIs, and clinical teams seem to be happy to start using these solutions in trials.
- The industry needs to spend more resources in convincing regulators of the value and work towards standardization. The expectation is that the regulatory changes will be slower in Europe compared to the US.
- Payor and insurance companies are more open to use digital vs. traditional biomarkers when the ROI is clear. Pharma companies can potentially use digital measurements for commercial purposes, i.e. using the data to justify the reimbursement of a drug, rather than its regulatory approval.
- Besides clinical validation, usability to the specific population in the trial is key to ensure the adoption and proper use of the technology. This is also important if there is an expectation of post market use. In the future, wearables will likely become more commoditized and there will be specific companies that provide the algorithms and analytics on the raw data from these devices.
- Change is hard but possible, sleep is an example. While for other measurements, digital technologies are not widely used, the sleep industry moved from ePRO to patches and watches, which has become the norm. It started with some studies comparing sleep measurements between traditional methods and wearables. The validation studies showed equivalency and improved quality of life. This now has become the standard, but how can other vendors and sponsors get to that point is still hard to answer.
- From the sponsor perspective, the key is to first identify the right digital measurement for their trial. The selection of the device comes last, where it will be important to ensure the device is trustworthy and picks up exactly what needs to be measured.