Study Operations

Use of Central IRBs for Multi-center Clinical Trials

APRIL 25, 2012 TO APRIL 26, 2012

CTTI Project: Single IRB

Meeting Background:

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multi-center trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections recommending this approach. The goal of the CTTI project is to identify potential solutions to address barriers to the adoption of central IRBs for multi-center clinical trials.

Meeting Objectives:

  • Present research findings from the CTTI project entitled, Use of Central IRBs for Multi-center Clinical Trials
  • Discuss research findings among experts present at the meeting
  • Solicit additional feedback to refine proposed solutions

Meeting Location:

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

Obtaining Novel Endpoint Reliability and Acceptance Expert Meeting

JULY 27, 2021 TO JULY 28, 2021

CTTI Project: Developing Novel Endpoints

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 Agenda

Meeting Summary

List of meeting attendees

Pre-Meeting Materials

Full Presentation Set - Day 1

Full Presentation Set - Day 2

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.

The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies

JANUARY 13, 2021

CTTI Project: Clinical Trial Issues Related to COVID-19

Meeting Overview:

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 for future pandemics

The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and findings of a pre-summit survey that offered best practices and insights from those involved in COVID-19 treatment master protocols, specifically those setting up new sites and recruiting participants at existing sites.

This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.

Meeting Location:

Virtual Meeting

Meeting Agenda

Meeting Materials:

Watch Public Summit

Presentation Slides

Survey Results Slides

Articles of Interest

Master Protocol COVID Treatment 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.

Qualifying Investigators to Conduct Sponsored Clinical Trials

DECEMBER 13, 2017 TO DECEMBER 14, 2017

CTTI Project: Investigator Qualification

Meeting Objectives:

  • Report evidence gathered on:
    • Critical tasks associated with clinical investigators’ conduct of clinical trials.
    • Gaps and redundancies in training for preparing clinical investigators to conduct clinical trials.
    • Suggested knowledge and skills necessary for the quality conduct of clinical trials.
  • Evaluate proposed framework of characteristics within control of clinical investigator sites that define the quality conduct of a clinical trial.
  • Discuss how preparing clinical investigators for the quality conduct of a clinical trial could be optimized.
  • Identify the recommendations and tools that sponsors and investigators could implement to better prepare clinical investigators for the quality conduct of a clinical trial. Also, pinpoint the barriers—and solutions—to implementing these recommendations.

Meeting Location:

Hyatt Regency Bethesda 1 Bethesda Metro Center, Bethesda, MD 20814

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Welcome and Review of Aligned CTTI Work by Annemarie Forrest
  2. The CTTI Investigator Qualification Project and Meeting Goals by Jennifer Goldsack
  3. A Changing Ecosystem – A Brief Review of ICH GCP Renovations Planned and Currently Under Way by Theresa Mullin
  4. Proposed Framework of Characteristics that Define the Quality Conduct of a Clinical Trial by Janette Panhuis
  5. Evidence Gathering: Our Approach to Data Collection by Teri Swezey
  6. Critical Tasks that our Evidence Suggests Should be Well Executed to Drive the Quality Conduct of a Clinical Trial by David Ciavarella
  7. Perceived Risks to the Quality Conduct of Clinical Trials by Kate Haratonik
  8. Knowledge and Skills our Evidence Suggests may be Needed to Perform Critical Tasks and Mitigate Risks to Quality Trial Conduct by Catherine Dillion
  9. Evaluating Current Approaches to Preparing Investigators and Their Delegates by Patricia Hurley
  10. Building a Learning Ecosystem by Tina Chuck
  11. Case Study of an Investigator Mentoring Program by Emily Lemons
  12. Delivering Effective Training to Investigators and Their Delegates by Tina Chuck
  13. An Investigator's Reflections on Training by Christine Hildebrand
  14. FDA's Perspective on GCP Training by Bridget Foltz

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.

Strengthening the Investigator Community Project

APRIL 05, 2017

CTTI Project: Investigator Community

Meeting Objectives

  • Present findings from CTTI’s Strengthening the Investigator Site Community Project: Expert Interviews and Survey
  • Receive feedback on identified challenges experienced by principal investigators and strategies to overcome these challenges
  • Identify essential elements necessary to strengthen and grow the community of productive, experienced site investigators
  • Develop strategies and best practices to promote the growth and strengthening of the community of experienced site investigators
  • Identify barriers to strategy implementation and propose solutions

Meeting Location:

Sheraton Silver Spring Hotel 8777 Georgia Ave., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

1. Issue, Project Overview, and Meeting Objectives by Diana Foster
2. One and Done Survey Design and Findings by Christopher Fordyce
3. Active Investigator Interview Findings by Terri Hinkley Key
4. Elements for Site Investigator Success by Matthew Roe
5. Fiscal Responsibility and Discipline by Kaitlin Malone
6. Optimizing Trial Execution and Conduct by Robin Douglas
7. Investigator Perspective: My Approach / Why Do I Remain Involved? by David Whellan
8. PCORnet by Matthew Roe
9. A Primer in FDA Resources for Clinical Investigators by Bridget Foltz
10. FDA Observations Related to Investigator Participation by David Burrow

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.