Patient Engagement

Decentralized Clinical Trials Update Expert Meeting

AUGUST 25, 2021 TO AUGUST 26, 2021

CTTI Project: Supporting Decentralized Trial Approaches

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 – from operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping)
  • Understand current practices for incorporating DCT solutions in clinical trials, including considerations for protocol design and safety monitoring
  • Identify opportunities to increase adoption of DCT solutions moving forward

*For the purposes of this meeting, DCTs were defined as those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).

Meeting Location:

Virtual Meeting

Meeting Agenda

Meeting Summary

List of Meeting Attendees

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Pre-Meeting Landscape Scan Results

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.

Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

CTTI Project: Patient Group Engagement

PDF icon Download Slides 

Webinar Presenters

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

Patient Advocacy/Industry Partnerships to Accelerate Therapy Development

CTTI Project: Patient Group Engagement

Webinar Presenters:

  • Sharon Hesterlee, Ph.D., Vice President Research, Parent Project Muscular Dystrophy
  • Holly Peay, MS CGC, Vice President, Education and Outreach, Parent Project Muscular Dystrophy, and Director, DuchenneConnect Registry

*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.

Webinar Objective

Sharon Hesterlee and Holly Peay discuss the ways in which Parent Project Muscular Dystrophy (PPMD) has partnered with industry to accelerate therapy development for Duchenne Muscular Dystrophy.

Webinar Resources:

Increasing Diversity in Clinical Trials Recommendations Launch

CTTI Project: Increasing Diversity in Clinical Trials

Webinar Presenters:

  • Richardae Araojo, U.S. Food & Drug Administration (FDA)
  • Ruma Bhagat, Genentech - a member of the Roche Group
  • Sara Calvert, CTTI
  • Luther T. Clark, Merck & Co, LLC
  • Dawn Corbett, National Institutes of Health Office of Extramural Research (OER)
  • Tesheia Johnson, Yale University
  • Jane Williams, Syneos Health
  • Glendon Zinser, Susan G. Komen

Webinar Resources:

Download PowerPoint slideset

Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development v2

CTTI News | September 23, 2024

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Recruitment, Regulatory Submissions + Approvals, Safety, Site Planning

The recording for the hybrid public workshop on AI in Drug and Biological Product Development convened and hosted by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held August 6, is now available. Over 9,000 registrants from diverse backgrounds and perspectives joined to explore the responsible use of AI in drug development. 

During the workshop, we learned from experts as they discussed guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts discussed their rationale for particular approaches, shared their methods for evaluating success, recounted challenges and obstacles, explored options for scaling and wider applicability, and outlined considerations for moving forward. Presentations can also be found here. 

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CTTI’s Newest Steering Committee Patient/Caregiver Representatives Will Support Goal to Transform Trials

CTTI News | July 22, 2024

Topics Included: Patient Engagement

A core principle of CTTI’s vision to Transform Trials 2030 is to create a collaborative, patient-centered clinical trials landscape that fully integrates patients and patient organizations into the design and governance of studies. The addition of two new Steering Committee patient/caregiver representatives, Ella Balasa and Megan O’Neil, will play a key role in this bold initiative. 

Balasa and O’Neil, as advocates for the patient/caregiver perspectives, will collaborate with existing Steering Committee members and provide essential information and viewpoints on current patient needs. They will enhance the committee by contributing ideas, helping to conduct and analyze new strategies, disseminating CTTI recommendations, and encouraging the adoption of system changes.   

Both patient representatives selected bring a wealth of experience and unique perspectives that will enrich and inform CTTI’s work to shape practices and increase the quality and efficiency of clinical trials. The contribution of these individual perspectives is essential to the system-wide transformation CTTI is making to the clinical trials landscape. 

Learn more about CTTI’s organizational structure, Steering Committee, and our Transforming Trials 2030 vision.

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