Janssen Clinical Innovation
igital health and patient-centricity are all the rage these days, with these topics appearing as key headlines across the industry. What does it mean, what’s the value, and why are we not there yet?
Patient-Centric Evidence Generation
Where Does Digital Come In?
Take physical activity as an example. There are several concepts and variables that can play a role:
- Overall physical activity volume
- Range of motion
- Intensity of activity
- Duration and/or frequency
- Season, weekday, time of day
- Standardized tasks, e.g., walking upstairs
What is Holding Back Adoption?
The other challenge with digital technologies is that they continue to evolve! Consider this example:
Value of Ecosystem Collaboration
Think about how aerospace companies design, assemble, and operate very complicated but efficient and safe airplanes across the entire air travel ecosystem. Collaboration among different component manufacturers and airlines is routine. These planes can take off and land from most airports anywhere in the world, with passengers, their bags, and other cargo finding their way to the intended destination. Airports act as service integration and sharing hubs with security, baggage handling, etc. All of this is available to passengers for a surprisingly low cost considering the complexity involved. This is only possible in a highly standardized and integrated ecosystem.
Contrast this to clinical development, where technology and service interoperability is not built in by default, and where clinical trials are constructed individually and take months to start up. Better harmonization and modernization of the ecosystem would benefit everyone and would help bring down the time and cost of drug development.
The FDA is working on its Patient Focused Drug Development (PFDD) guidance series. The series offers practical guidance that companies can adopt immediately. However, there is still a gap in how scientific advice regarding the definition and interpretation of novel digital measures is shared within the ecosystem. Most of this kind of information is exchanged privately between companies and regulators, which limits transparency and adoption of common standards. This in turn hinders consistent evidence generation and is holding the community back from utilizing the best that technology and science has to offer.
The table below summarizes some of the opportunities, challenges, and suggestions.
- Health authorities to play a more direct role in coordinating between parties
- Creation of a common pre-competitive environment for publishing definitions and scientific advice
- Create more accessible open collaboration environments
- Facilitated collaboration, pre-packaged collaboration frameworks
- Create shared catalogue(s) for asset exchange
- Collaborative development of novel solutions where parties have the same interest
- Health authorities to play a more direct role in coordinating between parties
- Creation of a common pre-competitive environment for publishing definitions and scientific advice
- Create more accessible open collaboration environments
- Facilitated collaboration, pre-packaged collaboration frameworks
- Create shared catalogue(s) for asset exchange
- Collaborative development of novel solutions where parties have the same interest