Site Planning

Real-World Data and Evidence in the Evaluation of Medical Products

JUNE 12, 2018 TO JUNE 13, 2018

CTTI Project: Real-World Data

Meeting Scope:

  • Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
  • Real-World Evidence (RWE) is the clinical evidence regarding the usage, and potential benefits and risks, of a medical project derived from analysis of RWD.
  • The focus of this meeting and project is to explore the appropriate use of electronic health records and payment claims (RWD) in randomized clinical trials (RCTs) to generate RWE to support regulatory decision-making.

Meeting Objectives:

  • Present findings from evidence gathering activities.
  • Identify barriers and potential solutions to generating RWE for regulatory submissions from these RWD sources.
  • Describe what recommendations and resources CTTI should develop to equip change agents to increase appropriate use of RWD in RCTs, including to support regulatory submissions.

Meeting Location:

DoubleTree by Hilton Hotel Bethesda-Washington DC 8120 Wisconsin Ave., Bethesda, MD 20814

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to the Clinical Trials Transformation Initiative (CTTI) by Pamela Tenaerts
  2. Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
  3. Qualitative Interview Findings by Jack Sheehan
  4. Use of RWD in Pre-Study Planning and Study Set Up Session Introduction by Jane Perlmutter
  5. Use of RWD in Pre-Study Planning & Study Set up: Health Plan Perspective by Kevin Haynes
  6. Use of RWD in Pre-Study Planning & Study Set up: Manufacturer Perspective by Ben Gutierrez
  7. Using the Cystic Fibrosis Patient Registry to Support Clinical Trials Planning by Aliza Fink
  8. Use of RWD in Study Recruitment and Enrollment: EHR Enabled Platform by James Hamrick
  9. Patient & Site Identification Using an EMR Data System by David Thompson
  10. Real-World Treatment Responses in Advanced NSCLC Patient Subgroups by Michael Lu
  11. Real World Data Use in Embedded Pragmatic Clinical Trials by Sarah Leatherman
  12. Use of Real-World Data within ADAPTABLE, The Aspirin Study by Brad Hammill
  13. Day One Recap and Discussion of Priority Insights by Khair ElZarrad

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.

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.

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.

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.

Recent Webinars

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.