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.
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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 2 of 2 results
A Shared Perspective of Patient Technology Implementation in Clinical Trials
This document shares insights from an industry-wide data collection exercise led by TransCelerate BioPharma Inc. on the implementation of patient technologies in clinical trials. It highlights the challenges, successes, and lessons learned from 81 clinical trials conducted globally between 2013 and 2018. The analysis emphasizes the importance of careful planning, risk mitigation, patient and site training, and continuous feedback loops to enhance technology adoption and usability. It also addresses regulatory and infrastructure considerations to streamline technology integration across diverse geographic locations.
A Shared Perspective of Patient Technology Implementation in Clinical Trials
2020
TransCelerate
Lessons learned
,
Recommendations / best practices
Authors
Uday Deore, Katrin Ong, Janine Reis, Harry Tunnell, Paulo Covizzi, Farhan (CJ) Hameed, Tyler Reynolds
This document shares insights from an industry-wide data collection exercise led by TransCelerate BioPharma Inc. on the implementation of patient technologies in clinical trials. It highlights the challenges, successes, and lessons learned from 81 clinical trials conducted globally between 2013 and 2018. The analysis emphasizes the importance of careful planning, risk mitigation, patient and site training, and continuous feedback loops to enhance technology adoption and usability. It also addresses regulatory and infrastructure considerations to streamline technology integration across diverse geographic locations.
Findings
Patient technologies were used across 55 countries, with mobile applications (53%) and wearable devices (33%) being the most common technologies.
Common data issues included data transmission failures, duplicate or missing data, and integration challenges with other datasets.
Factors like technical literacy, device usability, and preferences for paper-based alternatives affected adoption rates, particularly in elderly populations.
Varying broadband connectivity, importation hurdles, and compliance with regulations like GDPR posed significant challenges.
Most sponsors (54%) were willing to reuse technologies, citing improved retention, compliance, and remote monitoring capabilities as key benefits.
Recommendations
Consider patient demographics, such as age and technical literacy, when selecting and implementing technologies.
Offer multi-format training for sites, patients, and monitors, and provide robust support systems to address technical and compliance issues.
Risk Mitigation: Anticipate potential issues like data loss, non-compliance, and technical failures by incorporating backup processes into protocols.
Conduct feasibility assessments for site infrastructure and regulatory compliance in target regions to minimize delays.
Regularly gather experiential feedback from patients to refine technologies and improve future trial designs.
Regulatory Considerations
Seek advice from regulators to ensure patient technologies align with clinical trial protocols and data submission requirements.
Ensure Compliance with GDPR and Local Regulations: Address privacy concerns and adapt technologies to meet country-specific requirements.
Prepare Documentation for Importation: Account for additional time and costs related to import licenses and customs requirements.
Plan for the impact of technical updates on clinical data reliability and regulatory submissions.
Patient technologies were used across 55 countries, with mobile applications (53%) and wearable devices (33%) being the most common technologies.
Common data issues included data transmission failures, duplicate or missing data, and integration challenges with other datasets.
Factors like technical literacy, device usability, and preferences for paper-based alternatives affected adoption rates, particularly in elderly populations.
Varying broadband connectivity, importation hurdles, and compliance with regulations like GDPR posed significant challenges.
Most sponsors (54%) were willing to reuse technologies, citing improved retention, compliance, and remote monitoring capabilities as key benefits.
Recommendations
Consider patient demographics, such as age and technical literacy, when selecting and implementing technologies.
Offer multi-format training for sites, patients, and monitors, and provide robust support systems to address technical and compliance issues.
Risk Mitigation: Anticipate potential issues like data loss, non-compliance, and technical failures by incorporating backup processes into protocols.
Conduct feasibility assessments for site infrastructure and regulatory compliance in target regions to minimize delays.
Regularly gather experiential feedback from patients to refine technologies and improve future trial designs.
Regulatory Considerations
Seek advice from regulators to ensure patient technologies align with clinical trial protocols and data submission requirements.
Ensure Compliance with GDPR and Local Regulations: Address privacy concerns and adapt technologies to meet country-specific requirements.
Prepare Documentation for Importation: Account for additional time and costs related to import licenses and customs requirements.
Plan for the impact of technical updates on clinical data reliability and regulatory submissions.
Keywords
Clinical trials
Co-design
Data collection
Data management
Data privacy and security
Device selection
Digital clinical measures
Digital endpoints
Digital health technologies (DHTs)
Feasibility studies
Frameworks
Patient centricity
Patient engagement
Patient experience
Regulatory guidance
Risk management
Scalability
Sensor-based digital health technologies (sDHTs)
Technology adoption
Usability
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.
Patient Technology Implementation Framework
TransCelerate provides a structured framework to guide the implementation of patient technologies (PT) in clinical trials. The framework consists of six stages: strategy development, use case ideation, use case development, proof of concept, technology pilot, and expansion. It emphasizes iterative and holistic planning, addressing organizational challenges, and aligning PT implementation with long-term strategic goals. The framework also includes tools and resources to support patient and site engagement, technology evaluation, and data-driven decision-making.
Patient Technology Implementation Framework
2018
TransCelerate
Framework or roadmap
,
Recommendations / best practices
Authors
TransCelerate
TransCelerate provides a structured framework to guide the implementation of patient technologies (PT) in clinical trials. The framework consists of six stages: strategy development, use case ideation, use case development, proof of concept, technology pilot, and expansion. It emphasizes iterative and holistic planning, addressing organizational challenges, and aligning PT implementation with long-term strategic goals. The framework also includes tools and resources to support patient and site engagement, technology evaluation, and data-driven decision-making.
Findings
Successful PT implementation requires iterative planning across six stages to adapt to changing study goals and patient needs.
Early engagement with patients, caregivers, sites, and regulatory bodies is critical to align PT goals with stakeholder priorities.
Identifying technical, operational, and compliance risks early on is essential for smooth implementation and scalability.
Rapid, small-scale tests of technologies can help address unknowns, refine user experience, and mitigate technical risks before full-scale pilots.
Scaling PT across geographies and populations requires addressing regional variations in infrastructure, regulations, and cultural acceptance.
Recommendations
Start with a clear, organization-wide PT strategy to align with clinical trial goals and define success metrics.
Involve patients, sites, and regulatory authorities early to gather insights and ensure alignment with their needs and priorities.
Test technologies in controlled environments to validate functionality, usability, and integration before pilot studies.
Use technology pilots to collect data on feasibility, usability, and implementation challenges to inform broader rollouts.
Leverage learnings from pilots to develop a scalable strategy that addresses technical, regulatory, and cultural barriers.
Regulatory Considerations
Determine whether the technology is classified as a medical device and ensure compliance with relevant regulations (e.g., FDA, EMA, MDR).
Address data protection regulations, such as GDPR, by implementing robust privacy measures and secure data storage practices.
Account for region-specific regulatory requirements and infrastructure challenges during scaling.
Proactively consult regulatory agencies during pilots to align on technology use, endpoints, and data validity.
Successful PT implementation requires iterative planning across six stages to adapt to changing study goals and patient needs.
Early engagement with patients, caregivers, sites, and regulatory bodies is critical to align PT goals with stakeholder priorities.
Identifying technical, operational, and compliance risks early on is essential for smooth implementation and scalability.
Rapid, small-scale tests of technologies can help address unknowns, refine user experience, and mitigate technical risks before full-scale pilots.
Scaling PT across geographies and populations requires addressing regional variations in infrastructure, regulations, and cultural acceptance.
Recommendations
Start with a clear, organization-wide PT strategy to align with clinical trial goals and define success metrics.
Involve patients, sites, and regulatory authorities early to gather insights and ensure alignment with their needs and priorities.
Test technologies in controlled environments to validate functionality, usability, and integration before pilot studies.
Use technology pilots to collect data on feasibility, usability, and implementation challenges to inform broader rollouts.
Leverage learnings from pilots to develop a scalable strategy that addresses technical, regulatory, and cultural barriers.
Regulatory Considerations
Determine whether the technology is classified as a medical device and ensure compliance with relevant regulations (e.g., FDA, EMA, MDR).
Address data protection regulations, such as GDPR, by implementing robust privacy measures and secure data storage practices.
Account for region-specific regulatory requirements and infrastructure challenges during scaling.
Proactively consult regulatory agencies during pilots to align on technology use, endpoints, and data validity.
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.