Expert Meetings

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.

Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach

OCTOBER 13, 2010 TO OCTOBER 14, 2010

CTTI Project: Quality by Design

Meeting Background:

The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify effective and efficient methods to monitor clinical trials. In seeking to identify how best to ensure the reliability of study results and the protection of trial participants, the project team has recognized that quality cannot be “inspected into” a trial but rather must be incorporated from the outset in the trial’s protocol design and operational conduct. To be effective, monitoring should be one component of an overall quality framework that allows potential issues to be identified and addressed as early as possible.

Meeting Objectives:

  • Describe, discuss, and evaluate novel approaches to clinical trial oversight
  • Propose an integrated model of quality management that will promote more efficient approaches to design, conduct and oversight of clinical trial
  • Identify the critical aspects of clinical trials that should be the focus of risk-based approaches to creating quality systems

Meeting Location:

Bethesda Marriott Suites, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Defining the Underlying Principles of Quality in Clinical Trials

Approaches to Risk-Based Quality Management

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.

Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?

NOVEMBER 14, 2017

CTTI Project: Single IRB

Meeting Objectives:

  • Review upcoming NIH policy and Common Rule changes regarding single IRB review as well as existing FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials.
  • Discuss the remaining gaps in knowledge, guidance and tools for implementing a single IRB review model.
  • Propose solutions regarding implementation of single IRB model for federally funded (e.g., NIH-sponsored), and for FDA-regulated drug and device, multicenter clinical studies.

Meeting Location:

DoubleTree by Hilton Hotel Silver Spring, 8727 Colesville Rd., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to CTTI and the Single IRB Project by Sara Calvert
  2. NIH Single IRB Policy by Petrice Brown-Longenecker
  3. Changes to the Common Rule for Single IRB by Lyn Lau
  4. FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials by Bridget Foltz
  5. Resources from the CTTI Single IRB Projects by Cynthia Hahn
  6. SMART IRB Platform Overview by Petra Kaufmann
  7. SMART IRB Exchange NIH Trial Innovation Network by Emily Serdoz
  8. AAHRPP Proposed Single IRB Review Standard by Robert Hood

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.

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.

Antibacterial Drug Development: Developing a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

APRIL 22, 2013 TO APRIL 23, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek solutions for challenges in study design and conduct of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) studies by applying the Quality by Design (QbD) principles.

Meeting Location:

Bethesda, MD

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Session 1: The Challenges of HABP/VABP Trials

Session 2: How can QbD be used to address the challenges in HABP/VABP trials?

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.

Embedding Trials in Clinical Practice Expert Meetings

May 11, 2022 & September 21, 2022 

CTTI Project: Trials in Clinical Practice

MEETING OBJECTIVES: 

Meeting #1 Objectives:

  • Present findings from project’s evidence generation: in-depth interviews with study designers and implementers
  • Refine operational recommendations
  • Begin to strategize implementation of the operational recommendations

Meeting #2 Objectives: 

  • Develop strategies for implementing at least 2 of CTTI’s new recommendations into the planning of trials intended for regulatory review
  • Identify 3 implementation barriers that trial designers and health systems have the power to mitigate
  • Brainstorm relevant metrics to monitor and evaluate implementation of the selected recommendations

Meeting #1 Location: Virtual Meeting

Meeting Agenda

Meeting Summary

List of meeting attendees

Full Presentation Set

Meeting #1 Materials:

  • Session 1: Introduction to Embedding Trials in Health Care Settings 
    • Introduction to the Clinical Trails Transformation Initiative (CTTI) 
    • Trials in Health Care Settings Project Overview and Meeting Objectives 
    • Review of Project’s In-depth Interview Results 
  • Session 2: Leveraging Examples to Refine Recommendations 
    • Review of Project’s Draft Recommendations 
    • Case Examples 
  • Session 3: Strategizing Implementation of Recommendations 
    • Opportunities to Implement CTTI Recommendations 

Meeting #2 Location: Hotel Washington, 515 15th Street, NW Washington, D.C.

Meeting Agenda

Meeting Summary

List of meeting attendees

Full Presentation Set

Meeting #2 Materials:

  • Session 1: Paving the Way 
    • Integrating Clinical Research and Care: Perspectives from Groups Paving the Way 
    • TQ&A 
    • Trials in Clinical Practice Project Overview  
  • Session 2: Implementation Workshop 
  • Session 3: Developing Metrics of Implementation 
    • Level setting on what is meant by metrics and implementation 
    • Metrics Development: Breakout Groups 
    • Gaining Momentum 

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.

Recent Webinars

Anti-Bacterial Drug Development: Issues in the Design of Trials in Patients with Unmet Need and in Patients with Hospital-Acquired and Ventilator Associated Bacterial Pneumonia

OCTOBER 11, 2012 TO OCTOBER 12, 2012

CTTI Project: ABDD Unmet Need

Meeting Background:

With rising antibiotic resistance becoming an issue of global concern, the Clinical Trials Transformation Initiative (CTTI) convened a 2-day Antibacterial Drug Development Workshop on October 11-12, 2012 in Crystal City, VA. The workshop is part of a series of expert meetings to explore approaches for accelerating the development of new antibacterial drugs. The two topics of focus for this meeting were exploring a new paradigm for antibacterial drug development in areas of unmet need, and for the treatment of patients with pneumonia that develops in the hospital or while on a ventilator.  This workshop followed a think tank on statistical issues that was held on August 20, 2012, in Bethesda, MD, also hosted by CTTI.

There is an urgent need to develop new antibacterial drugs to treat patients with infections caused by bacteria that are resistant to available antibiotics.  Antibiotic resistance has been increasing, creating an unmet public health need.  This workshop was held in collaboration with FDA’s newly formed Antibacterial Drug Development Task Force within the Center for Drug Evaluation and Research (CDER).

The purpose of the workshop was to understand the challenges in the development of new antibacterial drugs for the treatment of patients with unmet medical need (e.g., patients with multi-drug resistant bacterial infections, who have limited or no options for treatment) and to identify potential solutions that would accelerate the drug development process.  Novel endpoints and possible solutions to challenges in trial design for the development of new antibacterial drugs that treat patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP and VABP) were also explored. A broad range of stakeholders participated in the meeting, including experts from academic institutions, hospitals, pharmaceutical industry, government, and patient advocacy groups.

“The workshop provided an excellent opportunity to discuss new development pathways for antibiotic drugs targeting infections for which we urgently need new antibiotic therapies.  Our collaboration with CTTI on this work is part of the CDER Antibacterial Drug Development Task Force’s efforts to accelerate the development of new antibiotics to address critical patient needs”, said Edward Cox, MD, Director of the CDER’s Office of Antimicrobial Products.

Meeting Objectives:

The goal of the first day of the workshop was to define potential pathways and explore new paradigms to accelerate the development of new antibacterial drugs that would address unmet medical need, including discussing acceptable levels of uncertainty related to the risks and benefits of such treatments. The second day focused on issues in clinical trial design including endpoints and operational efficiencies specific to the development of antibacterial drugs for treating patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Meeting Location:

Sheraton Crystal City Hotel, Arlington, VA

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

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.

Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

JUNE 12, 2014 TO JUNE 13, 2014

CTTI Project: Single IRB

Meeting Objectives:

  • Discuss practices, implementation strategies, and solicit additional suggestions for increasing the use of central IRBs for multi-center clinical trials
  • Present findings from the CTTI Central IRB Advancement project’s collection of IRB authorization agreements and standard operating procedures
  • Obtain additional feedback to refine proposed IAA template and tools

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

DAY 1 – JUNE 12 , 2014

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.

Antibacterial Drug Development Working Group Webinar

AUGUST 29, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The Clinical Trials Transformation Initiative hosted an Antibacterial Drug Development Program Working Group Webinar on Aug 29, 2013 to provide an update on the program, and to make further progress on developing streamlined elements for a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). This webinar was a follow-up to a recently held workshop last April. The agenda for this collaborative effort included an update from the Foundation of the NIH (FNIH) HABP/VABP Working Group, followed by a lively discussion that focused on aspects of study design and endpoints. As with prior meetings, a variety of stakeholders attended the workshop, including academia, clinical experts, patient advocates, regulators, representatives from pharmaceutical companies, and others involved in the clinical research enterprise. The working group will incorporate the insight gained into the development of recommendations for elements for a Pilot Protocol for HABP/VABP studies.

"It is reassuring to see the progress made since the CTTI expert meeting held last October. A broader range of stakeholders has helped each person consider new possibilities in a much more open way, and should lead to a pilot protocol with better results that everyone can accept and act upon. I look forward to pushing the envelope further for all HABP/VABP patients, including a serious discussion of when superiority trials can be considered." Said Deborah Collyar, President, Patient Advocates In Research (PAIR) who attended the webinar.

Meeting Location:

Online

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

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.