Topics Included: Data Collecting and Reporting, Innovative Trials
Program: Digital Health Trials
Related Projects: Developing Novel Endpoints, Planning Decentralized Trials, Selecting & Testing a Digital Health Technology, Supporting Sites, Interacting with Regulators
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Digital health technologies have fundamentally changed when, where, and how data can be collected. Yet the critical principle of data collection remains the same: ensuring the authenticity, integrity, and confidentiality of data over time.
Use CTTI’s recommendations and resources to help understand, plan for, and address the challenges associated with digital health technologies, including data access, ownership, sharing, and storage, as well as communicating trial data with participants.
Resources
Regulatory Submissions + Approvals | Publications
How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints
Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is...
Regulatory Submissions + Approvals | Case Studies
From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints
From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints
Innovative Trials | Case Studies
Small, But Mighty: How a Rare Disease Foundation Built Natural History Data to Accelerate New Therapies
Small, But Mighty: How a Rare Disease Foundation Built Natural History Data to Accelerate New Therapies
Innovative Trials | Resources
CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials
CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials
Site Planning | Case Studies
Clear Roadmap of Requirements Allows Roche to Speed Multiple Sclerosis App Development
Clear Roadmap of Requirements Allows Roche to Speed Multiple Sclerosis App Development
Innovative Trials | Recommendations
Digital Health Trials: Recommendations for Managing Data
Digital Health Trials: Recommendations for Managing Data
Innovative Trials | Resources
Digital Health Technologies Data Flow Diagram
Digital Health Technologies Data Flow Diagram
Innovative Trials | Resources
Decision Support Tool: Real-Time Data Sharing with Study Participants
Decision Support Tool: Real-Time Data Sharing with Study Participants
Innovative Trials | Publications
Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study
Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study
Innovative Trials | Resources
Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture
Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture
Innovative Trials | Resources
Table: Promoting & Protecting Data Integrity
Table: Promoting & Protecting Data Integrity
Innovative Trials | Resources
Table: CTTI Recommended Strategies for Optimizing Data Quality
Table: CTTI Recommended Strategies for Optimizing Data Quality
Regulatory Submissions + Approvals | CTTI News
CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials
Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in...
Innovative Trials | Publications
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative
Innovative Trials | Resources
Case Study: Returning Value to Participants without Compromising Study Integrity
Case Study: Returning Value to Participants without Compromising Study Integrity
Innovative Trials | Resources
Case Study: Sharing Data to Promote Patient Engagement
Case Study: Sharing Data to Promote Patient Engagement
Innovative Trials | Resources
Case Study: Using Remote, Smartphone-Based Data Collection to Share Health Insights
Case Study: Using Remote, Smartphone-Based Data Collection to Share Health Insights
Innovative Trials | Resources
Case Study: Optimizing Data Quality and Participant Privacy
Case Study: Optimizing Data Quality and Participant Privacy
Innovative Trials | Resources
Participant Summary: Site Investigator Perceptions of Mobile Clinical Trials – Summary of Interview Findings
Participant Summary: Site Investigator Perceptions of Mobile Clinical Trials - Summary of Interview Findings
Innovative Trials | Resources
Glossary: CTTI’s Digital Health Technologies Recommendations
Glossary: CTTI's Digital Health Technologies Recommendations
Innovative Trials | Resources
Appendix: Approaches to Securing Data Generated by Digital Health Technologies
Appendix: Approaches to Securing Data Generated by Digital Health Technologies
Innovative Trials | Resources
Appendix: Technical Approaches to Support the Correct Attribution of Data Collected Using Digital Health Technologies in the Field
Appendix: Technical Approaches to Support the Correct Attribution of Data Collected Using Digital Health Technologies in the Field