Modernizing the Digital Evidence Generation Ecosystem
Kai Langel
Janssen Clinical Innovation
D

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

We often hear the advice to “put yourself in the patient’s shoes” when talking about patient centricity. However, that is very hard or impossible to do. One strategy is to talk to patients directly and ask. A person with a chronic condition might have a different perspective and may already have adapted to live with it. For example, a person in a wheelchair might not feel “tied” to it, but rather appreciate it as the solution that improves their mobility and may care most about being able to continue using it. Consider the following examples:
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Where Does Digital Come In?

Digital technologies have the potential to unlock novel science and give us a new perspective – not too dissimilar to what imaging technologies have achieved. Continuous, objective measures that can be obtained through the course of patients’ daily lives can give us a whole new window to better understand the impact of disease and outcomes of interventions. In most cases, we are not replacing something old with a digital version of the same, but rather creating novel measures. This is both an opportunity as well as a major challenge. With modern technology, we can measure different concepts in different ways. The impacts of diseases are multivariate and there are countless potential concepts of interest.

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?

For comparable evidence generation, within and between companies, we need to align behind common standards. These standards need to include both the definition of the measurement concept as well as guidance for their clinical interpretation.

The other challenge with digital technologies is that they continue to evolve! Consider this example:

Apple Watch Gen 1
Apple Watch Gen 5
Introduced
April 24, 2015
September 20, 2019
Discontinued
September 7, 2016
September 15, 2020
Commercial life (months)
17
12
Apple Watch Gen 1
Introduced
April 24, 2015
Discontinued
September 7, 2016
Commercial life (months)
17
Apple Watch Gen 5
Introduced
September 20, 2019
Discontinued
September 15, 2020
Commercial life (months)
12
The viable commercial lifecycle of these devices is not only short but appears to be decreasing. This is a significant challenge even within a single clinical trial, which often takes years to design and execute. The problem gets worse within a development program, which may take a decade to complete. With some other components, such as algorithms, it can be even worse with certain algorithms that can change continually. Our broader drug development ecosystem–including technology and service providers, industry, and regulators–must work together to address these challenges.

Value of Ecosystem Collaboration

Let’s step back and consider how we work as an ecosystem in drug development.

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.

ITEM
OPPORTUNITY
CHALLENGES
RECOMMENDATIONS
Definitions of novel digital endpoints
Measure novel patient-centric concepts
Lack of mechanisms to adopt common standards
  • 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
Increased collaboration and harmonization
Increase the speed and consistency of adopting new technologies and methods
Collaboration environments are rigid and not inclusive of all stakeholders; Companies lack clarity in what areas can benefit from pre-competitive collaboration
  • Create more accessible open collaboration environments
  • Facilitated collaboration, pre-packaged collaboration frameworks
Re-usability and efficiency
Increased consistency, efficiency, and output of the ecosystem
Lack of efficient mechanisms for making assets, evidence, and data accessible within the ecosystem
  • Create shared catalogue(s) for asset exchange
  • Collaborative development of novel solutions where parties have the same interest
ITEM
Definitions of novel digital endpoints
OPPORTUNITY
Measure novel patient-centric concepts
CHALLENGES
Lack of mechanisms to adopt common standards
RECOMMENDATIONS
  • 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
ITEM
Increased collaboration and harmonization
OPPORTUNITY
Increase the speed and consistency of adopting new technologies and methods
CHALLENGES
Collaboration environments are rigid and not inclusive of all stakeholders; Companies lack clarity in what areas can benefit from pre-competitive collaboration
RECOMMENDATIONS
  • Create more accessible open collaboration environments
  • Facilitated collaboration, pre-packaged collaboration frameworks
ITEM
Re-usability and efficiency
OPPORTUNITY
Increased consistency, efficiency, and output of the ecosystem
CHALLENGES
Lack of efficient mechanisms for making assets, evidence, and data accessible within the ecosystem
RECOMMENDATIONS
  • Create shared catalogue(s) for asset exchange
  • Collaborative development of novel solutions where parties have the same interest
We are certainly moving in the right direction. The Innovative Medicines Initiative, the Critical Path Institute and TransCelerate have shown that there is space for pre-competitive collaboration. We can build on that to make it bigger, bolder, and broader.