Digital Health Trials

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

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CTTI Project: Developing Novel Endpoints

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 to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

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

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CTTI Project: Preparing a Site

During a public webinar today, 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 doing so, sponsors, contract research organizations, and other stakeholders can maximize the opportunities of mobile technologies to advance the development of new medical products.

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Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials

JUNE 15, 2017 TO JUNE 16, 2017

CTTI Project: Digital Health Trials

Meeting Objectives

  • Present findings from evidence gathering activities
  • Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile devices for objective data capture in clinical trials. Specifically,
    • possible solutions to key data challenges
    • scientific and technological considerations
  • Identify the change agents who will drive adoption of mobile devices for capturing objective data in clinical trials, including for the purposes of regulatory submission
  • Describe what products CTTI should develop to equip change agents to include mobile devices for data capture in clinical trials, including for the purposes of regulatory submission

Meeting Location:

DoubleTree by Hilton Hotel Crystal City 300 Army Navy Drive | Arlington, VA

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

1. The CTTI MCT Mobile Devices Project and Meeting Goals by Jennifer Goldsack
2. Human Adaptation to Information: A Challenge for the Next Decade by Robert Califf
3. Mobile Clinical Trials and CDRH's Regulation of Devices by Dharmesh Patel
4. Recommendations from CTTI’s MCT Novel Endpoints Project by Jennifer Goldsack
5. Presentation of Evidence on Data Challenges (Panel Presentation)
6. Presentation of Evidence on Scientific and Technological Issues (Panel Presentation)

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Obtaining Novel Endpoint Reliability and Acceptance Expert Meeting

JULY 27, 2021 TO JULY 28, 2021

CTTI Project: Developing Novel Endpoints

Meeting Objectives:

  • Identify the barriers and discuss solutions to the adoption of DHT-derived endpoints into pivotal trials
  • Discuss the data needed to prove that a DHT-derived endpoint is ready for a pivotal trial
  • Explore how collaboration and other new efforts can advance the adoption of DHT-derived endpoints

Meeting Location:

Virtual Meeting

Meeting Agenda

Meeting Summary

List of meeting attendees

Pre-Meeting Materials

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Meeting Materials:

Day 1

Day 2

The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Legal & Regulatory Issues Affecting the Adoption of Mobile Clinical Trials

JULY 11, 2017 TO JULY 12, 2017

CTTI Project: Supporting Decentralized Trial Approaches

Meeting Objectives

  • Present findings from evidence gathering activities
  • Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile technology in clinical trials
  • Describe what products CTTI should develop to equip change agents to overcome the legal and regulatory barriers that inhibit more widespread use of mobile technology in clinical trials, including for the purposes of regulatory submission

Meeting Location:

Sheraton Silver Spring Hotel 8777 Georgia Ave, Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to the Clinical Trials Transformation Initiative by Annemarie Forrest
  2. Offsite Trials by Leonard Sacks
  3. Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
  4. Qualitative Sponsor Interview Findings by David Babaian
  5. On the Ground and In the Cloud: Lessons Learned from Operating DCTs by Laura Podolsky
  6. Combining Crowdsourced Protocol Design and Digital Study Execution by Marc Foster
  7. Advancing Patient-Centered Clinical Trials by Implementing At-home Study Visits by Gail Adinamis
  8. Conducting Trials Remotely via Telehealth by Michael O’Brien
  9. Telehealth Public Policy Trends and Issues by Mario Gutierrez
  10. Telemedicine: Expanding Access, Protecting Patients by Lisa Robin
  11. Navigating State Telemedicine Laws by Ross Friedberg

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

SEPTEMBER 29, 2016 TO SEPTEMBER 30, 2016

CTTI Project: Developing Novel Endpoints

Meeting Objectives

Identify how to develop novel endpoints for use in clinical trials by writing the following use cases:

  • Parkinson’s Disease: Physical activity level and gait, measured using an accelerometer, as an endpoint for Parkinson's disease
  • Heart Failure: Physical activity level, measured using an accelerometer, as an endpoint for heart failure
  • Diabetes: Blood sugar level, measured using a wearable continuous glucose monitor, as an endpoint for diabetes
  • Muscular Dystrophy: Physical activity level, measured using

Meeting Location:

DoubleTree Silver Spring Hotel by Hilton, 8727 Colesville Rd, Silver Spring, Maryland

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations

  1. Mobile in Clinical Trials: Developing Novel Endpoints for use in Clinical Trials by Jennifer Goldsack
  2. Clinical Trial Endpoints from Mobile Technology: Regulatory Considerations by Elektra J. Papadopoulos
  3. Assessing and Supporting Outcome AssessmentsCategories, Context, and Evidence: Mobile Technology Novel Endpoints Workshop by Marc K. Walton
  4. Performance Outcome Assessments: Identifying Endpoints that are Meaningful and Measurable by Stephen Joel Coons
  5. Developing Performance Outcome Measures for Use with Regulatory Agencies: The Aging In Motion (AIM) Coalition Experience by Cynthia A. Bens
  6. Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials: The Use Case Approach by Jennifer Goldsack

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI’s Mobile Technologies Event

JULY 16, 2018

CTTI Project: Digital Health Trials

Meeting Objectives:

Share practical examples and best practices for:

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

Meeting Location:

FDA White Oak Campus 10903 New Hampshire Ave., Silver Spring, MD

CLICK HERE for the meeting agenda.

Meeting Materials:

Introduction to CTTI by Annemarie Forrest

Introduction to the Mobile Clinical Trials Project by Jen Goldsack

Session I: Technology Selection

Session II: Data Collection, Analysis, and Interpretation

Session III: Data Management

Session IV: Optimizing Protocol and Design Execution

Session V: Supporting FDA Submission and Inspection

Session VI: Mobile Technologies in Perspective

Additional Resources:

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.