Expert Meetings

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

Improving Pediatric Trials in Antibacterial Drug Development | No Sick Child Left Behind

APRIL 05, 2016

CTTI Project: ABDD Peds Trials

Meeting Objectives

  • Present findings
  • Identify remaining gaps that may require further exploration
  • Present and obtain feedback on draft considerations to improve the successful conduct and execution of pediatric antibacterial drug trials
  • Develop initial consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs

Meeting Location:

Sheraton Silver Spring Hotel, 8777 Georgia Avenue, Silver Spring, Maryland

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations

  1. CTTI History and Methodology: ABDD Program History by Jamie Roberts
  2. Pediatric Product Development in the 21st Century by Lynne Yao, M.D.
  3. Public-Private Partnerships to Support Pediatric Trials by Ed Connor, MD MBE
  4. Opportunities: Pediatric Trials Network by P. Brian Smith MD MPH MHS
  5. Pediatric Anti-bacterial and Anti-fungal Trials from 2007 to 2015: A Systematic Review of ClinicalTrials.gov by Joshua Thaden, MD, PhD
  6. Quantifying BPCA and PREA Submissions – Pediatric Labeling for Antibacterial and Antifungal Drugs by John Farley, MD MPH
  7. PENTA-ID by Mike Sharland
  8. Parental Decision Making About Enrolling Children in Clinical Trials: An In-depth Interview Study by Diane Bloom, MPH, Ph.D.
  9. Investigator Perspectives by Amy Corneli, PhD, MPH
  10. Findings: Perspectives from Community Providers by Rachel G. Greenberg, MD
  11. Industry Perspectives by Gary Noel
  12. Communicating with Parents: Approaches to Informed Consent by Breck Gamel
  13. Addressing the Challenges in Neonatal Infection Studies by P. Brian Smith MD MPH MHS
  14. Improving Clinical Trial Design: Meeting the Needs of Investigators by John Bradley, MD
  15. Breakout Report Outs

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 Large Simple Trials (LSTs)

MAY 13, 2013 TO MAY 14, 2013

CTTI Project: Large Simple Trials

Meeting Background:

The purpose of this meeting is to develop recommendations to facilitate and promote the adoption of LST designs for regulatory submissions or other purposes.

Meeting Objectives:

  • Discuss findings from a survey of practices
  • Discuss strategies that companies are using to implement LSTs
  • Discuss the challenges to LSTs

Meeting Location:

Hilton Washington DC/Rockville Hotel and Executive Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Day 1 - Session 1: Landscape of LSTs

Day 1 - Session 2: Models of Approaches to LSTs 

Day 2

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.

Increasing Diversity in Clinical Trials Expert Meeting

OCTOBER 12 & 21, 2021

CTTI Project: Diversity

Meeting Objectives:

  • Present findings from project evidence generation: in-depth interviews with key decision-makers.
  • Refine a maturity model for organizational-level strategies to increase diversity in clinical trials.
  • Identify specific multi-stakeholder, portfolio-level strategies to increase the participation of underrepresented racial and ethnic minorities and women in clinical trials.

Meeting Location: Virtual Meeting

Meeting Summary

Meeting Agenda

List of Meeting Attendees

Pre-Meeting Materials

Meeting Materials:

Day 1

 

Day 2

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.

ICH E6 Guideline for Good Clinical Practice – Update on Progress

MAY 18, 2021 TO MAY 19, 2021

CTTI Project: Informing the Update of ICH E6

On behalf of the International Council for Harmonisation (ICH), the ICH E6 Good Clinical Practice (GCP) Expert Working Group (EWG) held a free public web conference to provide an update on the progress to revise this important and impactful guideline. This web conference was convened by the Clinical Trials Transformation Initiative (CTTI).

The EWG held two similar meetings on Tuesday, May 18, 2021 (8-11 a.m. EDT) and Wednesday, May 19, 2021 (6-9 pm JST) to reach a broad global audience across time zones. As you will note on the agenda, the same topics were presented each day with speakers from different regions to represent the global effort. All information and presentations was provided in English.

Recorded presentations of the public web conferences are available above.

Meeting Location:

Virtual Meeting

Meeting Agenda - May 18

Meeting Agenda - May 19

Meeting Summary

Meeting Materials:

Video: ICH Guideline Development Process

Watch May 18 Web Conference

Watch May 19 Web Conference

 

Presentations:

Session 1 – General Introduction

Session 2 – E6(R3) GCP Expert Working Group (EWG) Vision & Engagement

Session 3 – Principles & Stakeholder Reflections

Full Web Conference Slide Deck

 

Additional Meeting Details:

ICH E6 GCP is the international ethical, scientific, and quality standard for the conduct of clinical trials for the development of new drugs and biologics involving human participants that are intended to support regulatory applications. Due to the wide impact of this important guideline, the ICH Management Committee is taking this unique step to provide a status update on the revisions to the guideline.

In this web conference, members of the ICH E6 EWG discussed the work-in-progress to develop principles and annexes for ICH E6 GCP (third version or E6(R3)) that are intended to be responsive across clinical trial types and settings and to remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on April 19, 2021, are designed to be flexible and applicable to a broad range of clinical trials. View the principles on the ICH website. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.

The EWG also discussed its plans and approaches to update the guideline in general and its engagement efforts with a variety of stakeholders that greatly enriched the discussions of the EWG. As part of these continued efforts to engage with stakeholders, the web conference included presentations from stakeholders on their vision and aspiration for clinical trial design and conduct that are responsive to the needs of the community.

View the full conference agenda here. For additional information on the ICH E6 revision efforts, please see the Reflection Paper on Renovation of Good Clinical Practice and the Concept Paper. For further information on the engagement approach, please see the published outline of the ICH E6 engagement proposal. Other materials, including the current guideline, "ICH E6(R2): Guideline for Good Clinical Practice," the business plan, work plan, an expert list, and reports of prior public engagements are available on the ICH website: https://www.ich.org/page/efficacy-guidelines.

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.

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.

CTTI Antibacterial Drug Development: Statistical Issues Think Tank Meeting

AUGUST 20, 2012

CTTI Project: Unmet Need

Meeting Background:

A CTTI-hosted Statistical Issues Think Tank Meeting was convened to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful for antibacterial drug development programs.

Meeting Location:

Bethesda Hyatt Regency, Bethesda, MD

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentation:

CTTI Statistics Think Tank for Anti-Bacterial Drug Development by Lisa LaVange

Resulting Publications:

1) Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance

On June 23, 2014, Statistics in Medicine published an article by Huque et al. that describes a novel clinical trial model to address the increased prevalence of antibiotic-resistant bacterial infections. This paper resulted from the CTTI-hosted Statistical Issues Think Tank Meeting that author Mohammad Huque attended.

2) The Role of Statistics in Regulatory Decision Making

In February, 2014, this peer-reviewed article was published in Therapeutic Innovation & Regulatory Science. This paper resulted from the CTTI-hosted Statistical Issues Think Tank Meeting where author Lisa M. LaVange, PhD, attended and presented. In this publication, LaVange concludes:

This article presents the author’s view of the important role that statisticians play in regulatory decision making, beginning with a broad overview of current office initiatives, including the development of guidance documents and a recent push for open and transparent collaboration with industry on methods development. Several recent examples are provided to illustrate the impact that statisticians can have on regulatory decisions through the use of strategic quantitative thinking. Also discussed are areas where it is believed that innovative statistical solutions or greater clarity on existing approaches is still needed.

3) Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products

On August 5, 2013, the Journal of Pharmaceutical Statistics published an article by Gamalo et al. that describes a Bayesian approach for the design and analysis of active comparator trials used in the development and market approval of antibacterial drugs. This work was presented in part at the CTTI-hosted Statistical Issues Think Tank Meeting.

“The CTTI Statistics Think Tank, a collaborative initiative with the FDA/CDER Anti-Bacterial Drug Development Task Force, was held in August, 2012 and provided an excellent opportunity for leading statisticians from academia, government, and industry to discuss innovative approaches for accelerating the development of new antibiotics. This article presents a comprehensive Bayesian approach to non-inferiority trials and represents but one of several approaches that were discussed at the Statistics Think Tank meeting. We look forward to additional research being published from the ideas generated at that meeting.” said Lisa LaVange Director of Biostatistics, Food and Drug Administration.

The Bayesian approach may allow for use of information from sources that include observational studies and early phase trials on the effect of the active comparator for study design. This approach may aid in reducing large sample size requirements and decrease study durations for antibacterial agents that enter late-stage clinical development.

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.