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Building the business case for digital endpoints
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Assessing the net financial benefits of employing digital endpoints in clinical trials
PUBLICATION
Industry benchmark paper demonstrating financial gains (eNPV and ROI) achieved through the adoption of digital endpoints.
Building the business case for digital endpoints
2025
Digital Medicine Society
Example or case study
,
Interactive tool
,
Recommendations / best practices
Authors
Building the business case for digital endpoints project team
This resource provides a strategic framework for building a successful business case for digital endpoints in drug development. It focuses on generating evidence that satisfies not only regulators but also payers and health technology assessment bodies to ensure reimbursement and market access. The document outlines key challenges, such as a lack of payer engagement and inconsistent evidence standards, and offers a roadmap for aligning stakeholders. The primary audience includes pharmaceutical developers, payer organizations, and patient advocacy groups, aiming to accelerate the adoption of digital measures in value-based healthcare.
Findings
Digital endpoints must not only support regulatory approval but also provide evidence that meets payer expectations for reimbursement and value-based care. The lack of early engagement with payers and health technology assessment (HTA) agencies is a key barrier to the adoption of digital clinical measures. Digital measures can enhance value-based care models by capturing patient-centered outcomes, reducing healthcare costs, and improving early disease detection. The scalability and generalizability of digital endpoints remain challenges, particularly for diverse populations and real-world healthcare settings. Technical and systematic barriers—such as data heterogeneity, stakeholder knowledge gaps, and inconsistent regulatory-payer alignment—are slowing the adoption of digital endpoint data for reimbursement decisions.
Recommendations
Pharma and medical product developers should engage early with payers and regulators to ensure digital endpoints align with reimbursement expectations. Payers and HTA bodies should establish clear evidence thresholds for digital endpoint validation, ensuring consistency in market access decisions. Digital endpoints should be validated against health-related quality of life (HRQoL) measures and patient-reported outcomes (PROs) to demonstrate clinical relevance. Real-world evidence (RWE) should be incorporated into clinical trials alongside digital endpoints to strengthen reimbursement applications. Stakeholders should prioritize scalable, patient-centered digital measures that capture disease progression over time and across different care settings.
Regulatory Considerations
Integrated Evidence Plans (IEPs) should be developed early to align digital endpoint evidence with regulatory and payer requirements. Digital endpoints should be assessed through multi-stakeholder collaboration, ensuring validation across pharmaceutical, regulatory, and reimbursement frameworks. Payers and regulators should work together to create aligned pathways for digital measure acceptance, reducing delays in market access. Data security, privacy, and interoperability must be addressed to support regulatory approval and patient trust in digital health solutions. The industry should leverage international regulatory-payer collaboration models, such as the HTA-EMA partnership and the FDA Payor Communication Task Force, to accelerate global digital endpoint adoption.
Digital endpoints must not only support regulatory approval but also provide evidence that meets payer expectations for reimbursement and value-based care. The lack of early engagement with payers and health technology assessment (HTA) agencies is a key barrier to the adoption of digital clinical measures. Digital measures can enhance value-based care models by capturing patient-centered outcomes, reducing healthcare costs, and improving early disease detection. The scalability and generalizability of digital endpoints remain challenges, particularly for diverse populations and real-world healthcare settings. Technical and systematic barriers—such as data heterogeneity, stakeholder knowledge gaps, and inconsistent regulatory-payer alignment—are slowing the adoption of digital endpoint data for reimbursement decisions.
Recommendations
Pharma and medical product developers should engage early with payers and regulators to ensure digital endpoints align with reimbursement expectations. Payers and HTA bodies should establish clear evidence thresholds for digital endpoint validation, ensuring consistency in market access decisions. Digital endpoints should be validated against health-related quality of life (HRQoL) measures and patient-reported outcomes (PROs) to demonstrate clinical relevance. Real-world evidence (RWE) should be incorporated into clinical trials alongside digital endpoints to strengthen reimbursement applications. Stakeholders should prioritize scalable, patient-centered digital measures that capture disease progression over time and across different care settings.
Regulatory Considerations
Integrated Evidence Plans (IEPs) should be developed early to align digital endpoint evidence with regulatory and payer requirements. Digital endpoints should be assessed through multi-stakeholder collaboration, ensuring validation across pharmaceutical, regulatory, and reimbursement frameworks. Payers and regulators should work together to create aligned pathways for digital measure acceptance, reducing delays in market access. Data security, privacy, and interoperability must be addressed to support regulatory approval and patient trust in digital health solutions. The industry should leverage international regulatory-payer collaboration models, such as the HTA-EMA partnership and the FDA Payor Communication Task Force, to accelerate global digital endpoint adoption.
Keywords
Clinical outcome assessment (COA)
Digital clinical measures
Digital endpoints
Drug development
Health technology assessment (HTA)
Market access
Patient-centered outcomes
Pricing and reimbursement
Real-world evidence (RWE)
Regulatory guidance
Stakeholder collaboration
Technology adoption
Value-based care
Technologies
Open Resource
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
Assessing the net financial benefits of employing digital endpoints in clinical trials
2024
Clin Transl Sci
Review
Authors
Joseph A DiMasi, Abigail Dirks, Zachary Smith, Sarah Valentine, Jennifer C Goldsack, Thomas Metcalfe, Upinder Grewal, Lada Leyens, Ute Conradi, Daniel Karlin, Lesley Maloney, Kenneth A Getz, Bert Hartog
This study provides a rigorous financial assessment of using digital endpoints in clinical trials for drug developers. Addressing the lack of quantifiable evidence, the paper uses an expected net present value (eNPV) framework to model the net financial benefits. The research quantifies the return on investment (ROI) by comparing operational gains, such as reduced trial durations and enrollment sizes, against the costs of implementing the underlying digital health technologies. The goal is to demonstrate the financial value of these tools, providing an economic justification for their broader adoption to accelerate the delivery of new therapies to patients.
Findings
The use of digital endpoints provides substantial financial value to drug developers, with significant positive changes in expected net present value (eNPV) and high returns on investment (ROI). These benefits are primarily driven by shorter clinical trial durations and smaller participant enrollment sizes. The financial gains are considerably larger in Phase III trials compared to Phase II, which is attributed to the higher probability of a drug successfully reaching the market from the later stage. While the upfront investment for implementation is significant, the financial returns justify the cost across the therapeutic areas analyzed.
Recommendations
Sponsors should develop cross-portfolio strategies for digital measures to optimize and scale the value captured across their development programs. Engaging in precompetitive collaborations is encouraged to share the risks and costs of development, harmonize new measures across the industry, and increase overall returns. Organizations should continue to invest in these capabilities, as their widespread adoption can transform the drug development process and, ultimately, deliver safe and effective treatments to patients sooner.
Regulatory Considerations
While a deep analysis of the regulatory environment is outside the paper’s scope, it acknowledges that the evolving regulatory landscape is critical for fostering innovation in clinical development. To support broader adoption and understanding, the authors suggest that clinical trial registries should expand their data collection to include specific details on the use and outcomes of digital endpoint strategies. This would improve transparency and help build the evidence base for the impact of these novel measures on clinical research.
The use of digital endpoints provides substantial financial value to drug developers, with significant positive changes in expected net present value (eNPV) and high returns on investment (ROI). These benefits are primarily driven by shorter clinical trial durations and smaller participant enrollment sizes. The financial gains are considerably larger in Phase III trials compared to Phase II, which is attributed to the higher probability of a drug successfully reaching the market from the later stage. While the upfront investment for implementation is significant, the financial returns justify the cost across the therapeutic areas analyzed.
Recommendations
Sponsors should develop cross-portfolio strategies for digital measures to optimize and scale the value captured across their development programs. Engaging in precompetitive collaborations is encouraged to share the risks and costs of development, harmonize new measures across the industry, and increase overall returns. Organizations should continue to invest in these capabilities, as their widespread adoption can transform the drug development process and, ultimately, deliver safe and effective treatments to patients sooner.
Regulatory Considerations
While a deep analysis of the regulatory environment is outside the paper’s scope, it acknowledges that the evolving regulatory landscape is critical for fostering innovation in clinical development. To support broader adoption and understanding, the authors suggest that clinical trial registries should expand their data collection to include specific details on the use and outcomes of digital endpoint strategies. This would improve transparency and help build the evidence base for the impact of these novel measures on clinical research.
Keywords
Technologies
Open Resource
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.