How to Select Digital Measurement Solutions in Clinical Trials: Introducing the New HealthXL Tool

Every day new digital health products are entering the market, making it difficult for clinical trial sponsors to determine how these products compare against one another. The combination of hardware and software products and the implementation of artificial intelligence algorithms add multiple layers of complexity to the evaluation process. 

So how can we help the clinical trial sponsors pick the right digital health products?

Introducing our free tool to rate digital measurement technology solutions for clinical trials  

HealthXL community members and industry leaders from pharma, digital health companies and decentralized trials providers have come together to create this new open-access tool to help sponsors select the best digital measurement technologies for clinical trial use.

• Who can use it?
  Our new open-access tool can be used by both sponsors and vendors during the technology selection process in the field of digital measurement solutions that support clinical research programs.
  
  

• How does it help?

The open-access tool helps you compare these digital health technologies and select the right tech for each particular trial. It also offers vendors a way to prepare a documentation package to support the sponsor evaluation process. This initiative continues to build upon the earlier work of the DiME V3 framework, the CTTI checklist and the HealthXL Vendor Assessment Guide. In combination with the 2021 HealthXL Vendor Assessment, this new tool can help you get a broad and deep evaluation of technology and vendor readiness for clinical trial use. 

Scope of the Tool

Within the scope of this new open-access tool are digital products (with or without hardware components) that can measure a health parameter associated with a meaningful aspect of health and where the measurement can be used as a biomarker or clinical outcome assessment (endpoint) in a clinical trial. Additionally, these digital products can be used to accelerate recruitment, reduce the patient burden and increase patients’ safety.

This new tool for digital measurement solution selection assumes that a study team has already expressed interest in incorporating a digital health product into its protocol design and that there is a clear connection to a recognized concept of interest. 

  *The tool is focused on 'Technology Assessment and Selection to meet study requirements'

Once the study teams and supporting technology functions agree on the parameter to measure, they must select a suitable technology or combination of technologies to measure that parameter for a specific patient population and this tool helps them do exactly that. 

How to Use the Tool?

This tool helps you rank technologies in several categories to help you pick the right one. Each of the following categories has a list of questions, which can be scored from one to five using the provided definitions: 

• Usability

• Utility

• Performance criteria of wearables

• Clinical validation

• Regulatory status

• Architectures of the measurement

• Security/privacy

• Measurement method

• Data component/ data set

• Data storage, data processing and data presentation

It is important to keep in mind the purpose of the trial while scoring for each question. The technology should score high only if it meets the purpose of the trial. 

Big Thanks to the HealthXL Community and Experts!

This tool is the result of collaboration between the HealthXL community and leading experts from pharma, digital health companies and decentralized trials providers. The open-source tool will provide an invaluable resource to those working on incorporating digital measurement technologies in clinical trials.

We sincerely thank each one of our contributors:

• Erwin De beuckelaer Director Innovative Capabilities at Johnson & Johnson 

• Richie Bavasso CEO/Co-Founder, nQ Medical 

• Jim Howard CEO, Readout Health 

• Peter Small CMO, Hyfe 

• Daniela Deflorio Company Director, DADAL Consulting Ltd 

• Larry Liu Sr. Director, Digital Endpoints, Medable 

• John Bunch Global Business Capability Lead mHealth, Bristol Myers Squibb 

• Jacek Lukawy Innovation Program Director, Novartis 

• Judit Faus i Garriga Community Manager, HealthXL 

Check out the free tool and introductory guide on the HealthXL platform here.

If you have any questions or need more information on the tool or the guide, please get in touch.