The Digital Health & Care Innovation Centre, in collaboration with the University of Strathclyde, has been working to identify ways to determine what treatments are best for patients and how treatments perform in the real world compared to controlled clinical trials. In particular, the use of digital technologies to collect real-world evidence (RWE) may provide answers to some of these questions.

The aim of this project was to define the current state (As Is) and propose the future options (To Be) by which medicines can be assessed and evaluated using digital solutions and to develop a top-level specification and early paper prototype of a ValMed system exemplified this via a use case focusing on Enzalutamide and Abiraterone for prostate cancer.

Janssen commissioned Phase 1 of project ValMed, and the involvement of Janssen in the project finished on delivery of the specification of the proposed approach in February 2021.

Impact & Value

By adopting digital health transformation approaches the project will demonstrate how it can benefit patients, clinical staff and NHS organisations.

The main impacts will be to:

  • Identify how real-world data can be used to assess and measure the value of medicines in the real world
  • Support Realistic Medicine
  • Enable outcome measurement in medicine assessment, management and related decision making
  • Improve the sustainability of healthcare
  • Help address health inequalities

What are we doing?

Janssen and the Digital Health & Care Innovation Centre, working with academics from the University of Strathclyde, identified a need for the development of digital approaches to outcome measurement to be used in medicines value assessment using real-world evidence, integrating and supporting care pathways and resource allocation decisions.

Janssen commissioned DHI and academics from the University of Strathclyde to develop an approach to address this need.

The focus being:

  • Can we prove a concept?
  • What are the practical benefits this proof of concept could have?
  • Using prostate cancer as a use case – findings will have applications beyond cancer

Why are we doing this?

To allow us to understand the impact and value of particular medicines on individual patients.

To do this we need to develop a methodology to use real-world data to assess patient outcomes.

This methodology will include:

  • Testing/proving some central pillars of real-world data
  • Adding to an emerging body of research and use of data
  • More focused pathways and treatment for patients
  • Opening the door to more Realistic Medicine

Why prostate cancer?

Prostate cancer was the chosen illness because:

  • It is the most commonly diagnosed male cancer (impacts 1 in 9 men in the UK)
  • Patients may live for relatively long periods of time
  • Well characterised with a significant body of knowledge to be built upon
  • Significant local research
  • Aspiration is to go beyond cancer to other illness areas

What are our drivers?

Janssen commissioned the Digital Health & Care Innovation Centre, working with academics from the University of Strathclyde to develop an approach to address this need.

Janssen’s aims:

  • More accurately and consistently evaluate outcomes as a measure of the value of medicines
  • Have a better understanding of patient preferences in the development of systems, using their data to assess value and inform clinical pathways
  • Support the sustainability of the appraisal system, to evolve in line with new and complex medicines

The partnership with the Digital Health & Care Innovation Centre and the University of Strathclyde was chosen due to our ability to complete ground-breaking research and our interest in patient-driven models of data capture

What might the outcomes be?

The potential outcomes will demonstrate how embracing digital health transformation approaches can benefit all by:

  • Identifying how data can track health outcomes
  • Supporting Realistic Medicine
  • Enabling outcome measurement in medicine assessment
  • Improving the sustainability of healthcare
  • Helping address health inequalities

How are we doing this?

This is a complex piece of research and therefore:

  • We have co-designed our approach with patients, health professionals and policymakers
  • The datasets have developed organically as part of the project
  • We have created a tool to allow the capture of additional patient-level data, that is not currently captured
  • The resulting data will fit seamlessly in with existing data available to clinicians
  • No additional data capture workload is required from clinical teams

Where are we now?

Phase 1 is complete with the Digital Health & Care Innovation Centre and academics from the University of Strathclyde delivering:

  • A review of the digital data landscape and capabilities
  • Insight from clinicians, academics and patients
  • A specification for the proof-of-concept tool
  • A low-level paper prototype, and wireframes of the tool for prostate cancer

What are the next steps ?

The next steps in the project are to:

  • Re-engage with clinicians, academics and patients
  • Refine the specification for the proof-of-concept tool
  • Develop a digital prototype of the tool and conduct a large-scale pilot study
  • Disseminate the work
  • Explore future funding opportunities