The demonstration project aims to:
- Develop a validated process to collect data in distributed patient-centered clinical trial protocols
- Prove of the value of patient-generated data
- Build a protocol appropriate for the chosen therapeutic area
- Articulate a standard lexicon of digital study types
- Define quality metrics for categorizing evidence used to designate digital tools as fit-for-purpose in a clinical application (could limit to clinical trials to constrain scope)
Why is this important?
To achieve broad adoption and positively impact health, digital medicine products require evidence to demonstrate that they are trustworthy. The quality and quantity of evidence required to deem a product fit-for-purpose are not agreed upon by industry, patient, or government stakeholders. Currently, there is no consensus on what constitutes “evidence” or what metrics should be used to distinguish high-quality evidence from low-quality evidence.
What will the project achieve?
Defining quality in study design and reporting will drive the field of digital medicine towards maturity by establishing consistency in the evidentiary base used to support clinical applications of digital medicine tools. This will in turn allow trials to be run in a distributed fashion, collecting more critical data which will help produce better outcomes and more precision medicines.
How will the project do this?
The project will combine inputs from the key areas of digital medicine – patients, CROs, sponsors and technology companies to ensure that each stakeholders requirements are considered.