CTTI

Meeting Presentations:

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

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 Presentations:

Intro to the Site Metrics Meeting
Site Metrics for Study Start-Up Project Overview
Bottlenecks of Study Start Up & Some Suggestions for Efficiencies by Christine Pierre
Workstream 1 Retrospective Data Analysis by Diana Abbott
Proposed Data Elements and Cycle Time Metrics for WS3 Prospective Data Collectionby Soo Bang

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.

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 Presentations

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

1.1 Welcome by Leanne Madre
1.2 Opening Remarks by Christopher Granger

Day 1 - Session 1: Landscape of LSTs

1.3 Perspectives on LST Trials by Michael Lauer
1.4 Patient Perspective on LST Trials by Carolyn Petersen
1.5 Opportunities for LSTs - Industry by Reshma Kewalramani
1.6 Opportunities for LSTs - Regulatory Sandra Kweder
1.7 Summary of Survey Results by Patrick Archdeacon

Day 1 - Session 2: Models of Approaches to LSTs

2.1 Models of Industry Trials for Regulatory Purpose (Efficacy/Effectiveness) by Christopher Granger
2.2 Models of Industry Trial for Regulatory Purposes (Safety) by Frank Cerasoli
2.3 Pragmatic Trials using EHR Platforms by Ryan Ferguson
2.4 Population-based trials with high cost-efficiency (VITAL) by JoAnn Manson
2.5 CHAMPION Program by Meredith Todd
2.6 CHAMPION Program – FDA Perspective by Stephen Grant
2.7 SHARP by Colin Baigent
2.8 JUPITER by Johannes Hulthe
2.9 SHARP and JUPITER - FDA Perspective by James Smith

Day 2

3.1 Summary of Day 1, including review of challenges to increased adoption of LST trial designs and potential solutions by Christopher Granger
3.2 Reflections on Challenges and Potential Solutions by Robert Temple

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

Watch May 18 Web Conference

Meeting Materials:

Video: ICH Guideline Development Process

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.

Master Protocol 2019 Expert Meeting

OCTOBER 22, 2019 TO OCTOBER 23, 2019

CTTI Project: Master Protocol Studies

Meeting Overview:
The purpose of the meeting was to explore and develop strategies to address common challenges related to the design and implementation of master protocols, including:

Mapping the pre-planning, planning, and execution processes of a master protocol trial.
Strategizing solutions to common roadblocks related to the pre-planning, planning, and execution of a master protocol study.
Identifying and prioritizing the creation of tools to support the adoption of emerging best practices outlined by CTTI’s roadmap.

Meeting Materials:

Full Presentation Set - Day 1

Full Presentation Set - Day 2

Welcoming Remarks & Meeting Overview

Introduction to the Clinical Trials Transformation Initiative (CTTI) - Annemarie Forrest, CTTI
VeloCTTI Master Protocol Project Overview - Kimberly Fisher, CTTI

Session I: Landscape Review

Landscape Review Findings - Nicholas Richardson, FDA, CDER
Multi-Stakeholder, Cross-Institutional Strategies for Change - Daniel Millar, Janssen Pharmaceuticals
Leveraging Master Protocols to Build Local Infrastructure & Technical Capacity for Low & Middle-Income Countries - Jay Park, MTEK Sciences

Session II: Building Capacity for Innovation

I-ACT for Children Overview - Ed Connor, I-ACT for Children
xCures Overview - Mika Newton, xCures

Session III: Small Group Breakout Sessions

Pre-Planning - Jane Perlmutter & Annemarie Forrest, CTTI
Planning - Marianne Chase, Massachusetts General Hospital & Kimberly Fisher, CTTI
Execution - Roger J. Lewis, Berry Consultants, LLC & Laura Shannon, CTTI
Large Group Discussion

Session IV: Tool Identification

Roadmap Strategy Session Instructions - Kimberly Fisher, CTTI
Breakout Session Facilitators
- Pre-Planning - Karen Dimick, Genentech & Annemarie Forrest
- CTTI Planning - Gene Vinson, Syneos Health & Kimberly Fisher
- CTTI Execution - Rajeshwari Sridhara, FDA, CDER, & Laura Shannon, CTTI
Large Group Strategy Session - Facilitator/Moderator: Nicholas Richardson, FDA, CDER

Session V: Next Steps & Closing Comments

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: 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 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.

Enhancing the Incorporation of Patient Perspectives in Clinical Trials

MARCH 18, 2019

CTTI Project: Patient Engagement

Meeting Overview:
CTTI and the FDA held this workshop in order to:

Seek ideas for best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up
Gather input from patients, caregivers, industry, academic researchers, and expert practitioners on the challenges and barriers to patient participation in clinical trials

You can watch the event, session by session:

Meeting Location:

Tommy Douglas Conference Center 10000 New Hampshire Ave., Silver Spring, Md.

Meeting Materials: