CTTI Meetings

Expert Meetings

  • Engaging Stakeholders in Trial Design Expert Meeting April 25, 2023
    April 4, 2023 CTTI Project: Engaging All Stakeholders in Clinical Trial Design Meeting Objectives: Review two clinical trial ‘models’ where stakeholder engagement was well-executed  Discuss and explore opportunities, barriers, and best practices for study designers to engage all stakeholders in trial design  Identify situation-specific considerations for ensuring engagement is appropriately equitable, effective, and feasible  Meeting Location: Washington, D.C. Meeting Summary Meeting Agenda List of Meeting Attendees Full Presentation Set Meeting Materials: Welcome Remarks and Opening Comments  Introduction to the Clinical Trials Transformation Initiative (CTTI)  Engaging Stakeholders in Trial Design Project Overview  Meeting Objectives  Session 1: Models ...
  • Disease Progression Modeling Expert Meeting March 22, 2023
    March 6, 2023 CTTI Project: Using Disease Progression Modeling to Advance Trial Design and Decision Making MEETING OBJECTIVES: Discuss disease progression modeling (DPM) and its current applications  Explore opportunities, barriers, and best practices for advancing the use of disease progression modeling to aid in decision making  Brainstorm relevant metrics to monitor and evaluate the recognition, value and consistent use of disease progression modeling   Meeting Location: Mayflower Hotel, Washington, D.C. Meeting Summary Meeting Agenda List of Meeting Attendees Full Presentation Set             Meeting Materials: Session I: Project ...
  • Embedding Trials in Clinical Practice Expert Meetings June 9, 2022
    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 ...
  • Increasing Diversity in Clinical Trials Expert Meeting October 21, 2021
    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 Welcome and Introduction Session I: Review of In-Depth Interview Findings Session II: Organizational Strategies to Increase Diversity in Clinical Trials – Yale Session III: ...
  • Decentralized Clinical Trials Update Expert Meeting August 25, 2021
    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 Meeting Location: Virtual Meeting Meeting Materials: Session I: Regulatory Perspectives & ...
  • Obtaining Novel Endpoint Reliability and Acceptance Expert Meeting July 27, 2021
    Meeting Objectives: Identify the barriers and discuss solutions to the adoption of DHT-derived endpoints into pivotal trials Discuss the data needed to prove that a DHT-derived endpoint is ready for a pivotal trial Explore how collaboration and other new efforts can advance the adoption of DHT-derived endpoints Meeting Location: Virtual Meeting Meeting Materials: Session I: DHT-Derived Novel Endpoint Development: Current Landscape Framing the Fit for Purpose DHT-Derived COA Endpoint Landscape Overview: Resources to Support Novel Endpoint Development Barriers to and Recommendations for Adoption of DHT-Derived Endpoints Session II: DHT-Derived Endpoints in ...
  • ICH E6 Guideline for Good Clinical Practice – Update on Progress May 18, 2021
    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) ...
  • The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies January 13, 2021
    CTTI hosted The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit on Wed., Jan. 13. The summit, conducted as a webinar and moderated by Pamela Tenaerts, CTTI, included a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and panel discussions moderated by Ester Krofah, FasterCures, and Mark McClellan, Duke-Margolis Center for Health Policy. The panel focused on solutions related to scaling master protocols, including: Overcoming barriers to starting up sites Increasing participants at existing sites Using the COVID experience to inform our preparedness ...
  • Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice June 4, 2020
    Meeting Overview: The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on Thursday, June 4, and Friday, June 5, from 10:00 a.m. – 1:00 p.m. EDT, to learn more about stakeholder experiences with the International Council for Harmonisation (ICH) Good Clinical Practice guideline (ICH E6). This stakeholder engagement web conference will inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making ...
  • Master Protocol 2020 Expert Meeting April 20, 2020
    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: