Study Operations

Expert Meeting on Site Metrics for Study Start-Up

MAY 04, 2010

CTTI Project: Study Start-Up

Meeting Background:

The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify core data elements that should be collected by all clinical trial sites to allow measurement and improvement of important timeframes for study start-up.

Meeting Objectives:

  • Review the results from retrospective analysis to describe the current state of study start-up at sites participating in multicenter clinical trials
  • Review, discuss and agree on a proposed list of standard metrics for site start-up activities including a standard, specific, and measurable definition for each metric that will be utilized in a prospective data collection pilot coordinated by CTTI
  • Discuss strategies for success and potential barriers for engaging sites to participate in the prospective data collection pilot that will be designed to facilitate and encourage sites to measure themselves against “sites like me” to identify opportunities for improving their internal processes and cycle times

Meeting Location:

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

Meeting Materials:

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.

Master Protocol 2020 Expert Meeting

APRIL 20, 2020 TO APRIL 21, 2020

CTTI Project: Master Protocol Studies

Meeting Overview:
The purpose of the meeting was to continue to drive the development of publicly available resources to support the successful design and implementation of master protocol studies. Specific meeting objectives included the following:

  • Refine CTTI tools to support the development of emerging master protocol studies in diverse therapeutic areas
  • Identify specific capacity building efforts to support cross-institutional collaboration in response to COVID-19 and other major public health threats

Meeting Materials:

Meeting Agenda

Meeting Summary

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Expert Meeting: CTTI IND Safety Advancement Project

JULY 21, 2015 TO JULY 22, 2015

CTTI Project: Safety Reporting

Meeting Objectives

  • Present findings and conclusions from the project evidence gathering activities
  • Discuss opportunities for improving the efficiency and value of the expedited IND safety reporting process
  • Understand opportunities for educating stakeholders on expedited IND safety reporting best practices

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Click here to view the presentation slides from this meeting.

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.

Expert Meeting on Good Clinical Practice (GCP) Training: Current Practices and Challenges

JANUARY 31, 2014

CTTI Project: Investigator Qualification

Meeting Background:

The goal of this meeting is to seek consensus on the key elements of GCP training and the frequency, format, and competency of training required to conduct clinical studies in the United States.

From left to right: Susan McHale, Bridget Foltz, Sheri Jacobsen, BSN, MA, Terri Hinkley, RN, BScN, MBA, CCRC, Jeffrey Cooper, MD, MMM, Barrett Katz, MD, MBA

Meeting Location:

Marriott North Bethesda, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Session 1: The Current Landscape for GCP Training

Session 2: Key Elements of GCP Training Programs

Session 3: Trainees and Differential Training by Job Function

Session 4: Frequency, Formats, and Demonstration of Competency

Session 5: Integrating GCP Principles In Clinical Research Conduct

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.

CTTI Recruitment Project Expert Meeting

NOVEMBER 09, 2015 TO NOVEMBER 10, 2015

CTTI Project: Recruitment

Meeting Objectives

  • Present findings from the CTTI Recruitment Project’s evidence gathering
  • Obtain stakeholder perspectives and critical feedback on draft considerations for more effective recruitment planning
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for moving recruitment planning upstream and achieving culture change
  • Identify implementation barriers to achieving change
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for overcoming barriers to achieving change

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

CLICK HERE to view the presentation slides from this meeting.

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 Data Monitoring Committees Project Expert Meeting

JULY 28, 2015 TO JULY 29, 2015

CTTI Project: Data Monitoring Committees (DMCs)

Meeting Objectives

  • Present findings and conclusions from the project survey and focus groups
  • Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Click here to view the presentation slides from this meeting.

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.

CTTI Informed Consent Project Expert Meeting

MARCH 10, 2015 TO MARCH 11, 2015

CTTI Project: Informed Consent

Meeting Objectives

  • Present findings and conclusions from the project literature review and expert interview series
  • Solicit feedback and develop consensus on proposed recommendations to enhance the informed consent process

Meeting Location:

DoubleTree by Hilton Hotel Washington DC, Silver Spring, MD

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.

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.

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