Welcome to the sDHT Adoption Library, featuring NaVi
NaVi is a closed-environment AI research assistant that leverages a carefully curated library of more than 300+ vetted documents, including FDA guidance and industry best practices. NaVi helps you search and explore content across the sDHT Adoption Library and Roadmap using natural language questions.
The Library is intended to serve as a living resource. Content is added periodically as new guidance, standards, and peer-reviewed research are released.
Meet NaVi: Your AI-Powered Research Assistant
Library scope and selection
To ensure high-quality, relevant results, the Library follows a predefined scoping approach:
- Inclusions: FDA guidance, non-commercial standards, and peer-reviewed research (2018–Present) focused on sDHTs being used as measurement tools for medical products in U.S.-based clinical trials.
- Exclusions: Materials from single commercial entities, non-U.S. regulatory bodies (except select EMA guidances with direct U.S. cross-relevance), and conference proceedings, and conference proceedings.
Inclusion in the Library does not imply endorsement, completeness, or regulatory acceptability.
Library Resources
Library scope
Resources in the sDHT Adoption Library are identified using a predefined scoping approach and include publicly available FDA guidance, non-commercial standards and guidance, and peer-reviewed research relevant to sDHT use in U.S.-based clinical trials. Materials from single commercial entities, non-U.S. regulatory bodies, conference proceedings, and studies conducted exclusively outside the United States are excluded; inclusion does not imply endorsement or regulatory acceptability.
Last updated 2026: Library content is reviewed and updated on a periodic basis as new eligible materials become available.
Showing 3 of 3 results
Building the business case for digital endpoints
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.
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.
3Ps of Digital Endpoint Value
This resource provides a strategic framework for ensuring that digital endpoints in drug development generate evidence that supports regulatory approval, reimbursement, and market adoption. The document emphasizes the importance of Integrated Evidence Plans (IEPs) to align stakeholders—including regulators, payers, and patients—throughout the drug development lifecycle. By bridging the gap between clinical trials and real-world application, the report aims to accelerate the adoption of digital measures in reimbursement and value-based care discussions. The resource focuses on three key stakeholder groups: pharmaceutical companies, payer organizations, and patients/patient groups
3Ps of Digital Endpoint Value
2022
Digital Medicine Society
Recommendations / best practices
Authors
3Ps of Digital Endpoint Value Project Team
This resource provides a strategic framework for ensuring that digital endpoints in drug development generate evidence that supports regulatory approval, reimbursement, and market adoption. The document emphasizes the importance of Integrated Evidence Plans (IEPs) to align stakeholders—including regulators, payers, and patients—throughout the drug development lifecycle. By bridging the gap between clinical trials and real-world application, the report aims to accelerate the adoption of digital measures in reimbursement and value-based care discussions. The resource focuses on three key stakeholder groups: pharmaceutical companies, payer organizations, and patients/patient groups
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
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.
FAQ: How will this endpoint benefit our trial?
This resource provides a worksheet to help identify potential benefits of developing and/or deploying a digital clinical measure as an endpoint in a clinical trial. It's intended for Medical Directors/Leads to use before selecting a digital measure for a pivotal clinical trial, in collaboration with key clinical trial team members. The worksheet outlines various questions to consider, along with possible responses and notes for ideation.
FAQ: How will this endpoint benefit our trial?
2020
Digital Medicine Society
Discussion guide
Authors
Digital Medicine Society
This resource provides a worksheet to help identify potential benefits of developing and/or deploying a digital clinical measure as an endpoint in a clinical trial. It's intended for Medical Directors/Leads to use before selecting a digital measure for a pivotal clinical trial, in collaboration with key clinical trial team members. The worksheet outlines various questions to consider, along with possible responses and notes for ideation.
Findings
Clinical trials often have unmet measurement needs, where traditional endpoints may not adequately characterize disease progression, treatment response, or new disease phenotypes.
Traditional trial designs can create a high patient burden, which can negatively impact the adoption of new measures by both clinicians and patients.
Clinical trials face significant operational challenges, including the risk of disruption, slow enrollment, poor medication adherence, and difficulty making early go/no-go decisions.
There is a need to improve the predictability rates for advancing new products from early-phase trials to pivotal trials.
Recommendations
Select digital measures to address specific unmet needs, such as to increase sensitivity in detecting disease worsening, characterize treatment response in subpopulations, or identify new disease phenotypes.
Prioritize digital measures that are well-received by clinicians and patients by demonstrating lower patient burden and higher patient relevance.
Deploy digital measures to improve trial efficiency and speed by reducing dependence on clinic visits, enabling earlier go/no-go decisions with higher resolution data, or improving medication adherence.
Use digital measures in early-phase trials to improve the probability of success for advancing new products to pivotal trials.
Consider digital measures that provide remote, continuous physiological insight to enable better oversight and remote management of trial participants.
Regulatory Considerations
When selecting a digital endpoint, a key consideration is whether the measure will increase the likelihood of regulatory approval or support a broader label claim.
A digital measure can strengthen a regulatory submission by generating more complete and patient-centric information that demonstrates the benefit of a new therapy.
Clinical trials often have unmet measurement needs, where traditional endpoints may not adequately characterize disease progression, treatment response, or new disease phenotypes.
Traditional trial designs can create a high patient burden, which can negatively impact the adoption of new measures by both clinicians and patients.
Clinical trials face significant operational challenges, including the risk of disruption, slow enrollment, poor medication adherence, and difficulty making early go/no-go decisions.
There is a need to improve the predictability rates for advancing new products from early-phase trials to pivotal trials.
Recommendations
Select digital measures to address specific unmet needs, such as to increase sensitivity in detecting disease worsening, characterize treatment response in subpopulations, or identify new disease phenotypes.
Prioritize digital measures that are well-received by clinicians and patients by demonstrating lower patient burden and higher patient relevance.
Deploy digital measures to improve trial efficiency and speed by reducing dependence on clinic visits, enabling earlier go/no-go decisions with higher resolution data, or improving medication adherence.
Use digital measures in early-phase trials to improve the probability of success for advancing new products to pivotal trials.
Consider digital measures that provide remote, continuous physiological insight to enable better oversight and remote management of trial participants.
Regulatory Considerations
When selecting a digital endpoint, a key consideration is whether the measure will increase the likelihood of regulatory approval or support a broader label claim.
A digital measure can strengthen a regulatory submission by generating more complete and patient-centric information that demonstrates the benefit of a new therapy.
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.