Digital Health Trials

Digital Health Trials

Topics Included: Data Collecting and Reporting, Innovative Trials, Regulatory Submissions + Approvals

Overview

Digital health trials are here to stay. Use CTTI's broad suite of recommendations and resources to design and run a successful, fit-for-purpose digital health trial that meets your research goals.

Areas of Focus

DEVELOPING NOVEL ENDPOINTS

Develop novel endpoints that more accurately represent the patient experience – and therefore – may be more meaningful to patients, providers, and others.

PLANNING DECENTRALIZED TRIALS

Learn about the foundational recommendations for designing and running a fit-for-purpose decentralized clinical trial.

SELECTING & TESTING A DIGITAL HEALTH TECHNOLOGY

Understand what needs to be considered and measured before selecting a digital health technology.

MANAGING DATA

Understand, plan for, and address the new challenges associated with managing data from digital health technologies.

SUPPORTING SITES

Develop a robust digital health technology management plan, accounting for testing, documentation, technical support, training, communication, data integrity, and participant safety.

INTERACTING WITH REGULATORS

Develop an appropriate strategy for collecting and sharing digital health trial data with regulatory bodies.

 

This Hub is a collection of recommendations and resources that have been created by multi-stakeholder teams. In the development of the Hub, CTTI has repackaged four original Digital Health Trials (formerly known as Mobile Clinical Trials) projects. Historical information including project team members and deliverables from each of these projects can be found here.

Resources

Site Planning | Press Releases

CTTI Offers Path Forward for Using Decentralized Clinical Trials

The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)—trials run through telemedicine and mobile health care providers—today at the DPharm:...

Site Planning | Press Releases

Conducting Multi-Center Trials: New Recommendations and Tool for Research

A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center clinical trials.

Innovative Trials | Press Releases

CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. CTTI's newly released recommendations and tools aim...

Site Planning | Press Releases

CTTI Releases Recommendations for Engaging Patients and Sites in Mobile Clinical Trials

During a public webinar, the Clinical Trials Transformation Initiative (CTTI) will release new recommendations and resources for engaging patients and research sites when planning and conducting mobile clinical trials. By...

Site Planning | Press Releases

CTTI Launches New Online Digital Health Trials Hub

Today the Clinical Trials Transformation Initiative (CTTI) announced a new online Digital Health Trials Hub featuring enhanced recommendations and additional resources.

Regulatory Submissions + Approvals | Expert Meetings

Obtaining Novel Endpoint Reliability and Acceptance Expert Meeting

Expert Meeting Recap and Materials

Site Planning | Expert Meetings

Decentralized Clinical Trials Update Expert Meeting

Meeting Objectives: In order to update CTTI's existing decentralized clinical trials (DCT)* recommendations, this expert meeting aimed to: Collect recent knowledge and insights - both what works and what doesn't...

Regulatory Submissions + Approvals | Webinars

Next Steps for Obtaining Novel Endpoint Reliability & Acceptance

CTTI Project: Developing Novel Endpoints Webinar Presenters: Michelle Crouthamel, AbbVie Jennifer Goldsack, DiMe Lindsay Kehoe, CTTI Alicia Staley, Medidata Webinar Resources: Download PowerPoint slideset Mentimeter Results

Site Planning | Webinars

CTTI’s Digital Health Trials Hub: Revised Recommendations and New Resources for DCTs and Novel Endpoints

CTTI Project: Developing Novel Endpoints and Planning Decentralized Trials Webinar Presenters: Megan Doyle, Amgen Jorg Goldhahn, ETH Zurich Phil Green, CTTI Lindsay Kehoe, CTTI Elizabeth Kunkoski, FDA Jeremy Wyatt,...

Site Planning | Webinars

Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits

CTTI Project: Clinical Trials Issues Related to COVID-19 Webinar Presenters: Pamela Tenaerts (Clinical Trials Transformation Initiative) Jacqueline Corrigan-Curay (FDA, CDER) Laura Cooke (Amgen) Bray Patrick-Lake (Evidation Health, Inc.) Ramya Thota...

Site Planning | CTTI News

CTTI Publication Explores Perceived Barriers and Recommendations Surrounding the Adoption of Decentralization

Despite widespread support for decentralization, real and perceived challenges remain, limiting wider implementation of decentralized elements. A new CTTI publication, published in the Journal of Therapeutic Innovation & Regulatory Science,...

Site Planning | Publications

Adoption of Decentralization: Are Our Perceptions Holding Us Back?

Adoption of Decentralization: Are Our Perceptions Holding Us Back?

Patient Engagement | Case Studies

FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers

FPWR's Questionnaire Measures Important - But Often Overlooked - Concerns for Prader-Willi Patients and Caregivers

Data Collecting and Reporting | CTTI News

CTTI Publication Investigates Challenges and Solutions Surrounding Digitally Derived Endpoint Acceptance

A new CTTI publication, published in Digital Biomarkers, investigates the challenges sponsors encounter when using digitally derived endpoints and offers potential solutions. Digital health technologies – including mobile apps, smart...

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

Site Planning | Case Studies

Accelerating eConsent Adoption During COVID-19

Accelerating eConsent Adoption During COVID-19

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

Regulatory Submissions + Approvals | Resources

Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints

Regulatory Engagement Opportunities when Developing Digitally Derived Endpoints

Formats

Stage of Trial