Projects

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.

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.

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.

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.

Pregnancy Testing in Clinical Trials Expert Meeting

JULY 15, 2013 TO JULY 16, 2013

CTTI Project: Pregnancy Testing

Meeting Background:

Designing a pregnancy testing protocol for a clinical trial requires balancing the performance characteristics of a given test, the baseline risk of pregnancy in a given subject population, the potential risks to the fetus from study interventions, and the effect of the testing protocol on overall study implementation in terms of burden to subjects, burden on staff, and direct costs. There are no published data on the consistency of sponsors, investigators, or institutional review boards (IRBs) in applying these criteria to designing and evaluating pregnancy testing protocols. However, anecdotal reports indicate that there is widespread variability.

Development of evidence-based guidance that explicitly considers the level of acceptable risk to suggest appropriate pregnancy testing protocols will ultimately improve protection of research subjects, reduce the risk of unintended fetal exposure, and reduce the workload of sponsors, investigators, IRBs, and other stakeholders in the clinical trial enterprise.

Meeting Objectives:

  • Present survey findings and computer simulation model results from the CTTI project entitled, Developing Rational Guidance for Pregnancy Testing in Clinical Trials
  • Discuss practices and challenges in assessing the acceptable risk of pregnancy and implementing a pregnancy testing protocol for a clinical trial
  • Solicit additional feedback and develop consensus on factors to consider when assessing acceptable risk of pregnancy in clinical trials

Meeting Location:

DoubleTree by Hilton Hotel, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

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.

Patient Groups and Clinical Trials Expert Meeting

JANUARY 21, 2015 TO JANUARY 22, 2015

CTTI Project: Patient Group Engagement

Meeting Objectives

  • Define consensus principles of Patient Group engagement from the 3-way (Industry, Patient Group, and Academia) stakeholder perspectives using case studies of success and barriers
  • Share evidence and key findings from a 3-way stakeholder assessment of Patient Group engagement in the Clinical Trial process
  • Gain understanding of the FDA Rules of Engagement and various Conflict of Interest (COI) issues
  • Solicit feedback on evidence to inform recommendations that can further enhance the value to industry, academia and patient groups of mutually beneficial partnerships that engage the patient groups as fully as possible in the complete spectrum of the clinical research enterprise
  • Solicit feedback on benchmarking, metrics, and value of patient engagement in clinical trials for research sponsors

Meeting Location:

Fairmont Hotel, Washington, DC

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

DAY 1 – JANUARY 21 , 2015

DAY 2 – JANUARY 22 , 2015

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.

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.

Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials

NOVEMBER 12, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek practical solutions to streamline the operational processes and build efficiencies for data collection in HABP/VABP trials.

Meeting Location:

Arlington, Virginia

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  • Introduction by Pamela Tenaerts

Session 1: Challenges in data collection for HABP/VABP trials

Session 1 Goal: Understanding the issues surrounding data collection in HABP/VABP trials

Session 1 Focus: Why reducing excessive non-critical data collection in HABP/VABP trials would improve data quality, and benefit investigators, sponsors, reviewers, and patients

Session 2: Regulatory requirements for AE data collection in registration trials

Session 2 Goal: Discuss different regulatory requirements and the challenges of meeting these requirements for data collection for HABP/VABP registration trials that are globally conducted, and evaluate whether future work is needed to harmonize approach to AE collection

Session 2 Focus: AE collection and adjudication of relatedness and seriousness; Reporting of SAE’s and SUSARS and evaluation

Session 3: Strategies to simplify data collection using a QbD approach

Session 3 Goal: To simplify the recording, monitoring, and review to make HABP/VABP trials more feasible and economical

Session 3 Focus: Reduction in the amount of data collected by identifying data that are critical to quality and those that may be essential to determine the benefit/risk of the treatment for registration, and those may be less informative

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.

The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward

MARCH 01, 2016

CTTI Project: Unmet Need

Meeting Objectives

  • Present perspectives from patients, caregivers and physicians on antibacterial drugs developed using streamlined approaches
  • Identify focus group themes and discuss topics which should be further explored or where draft recommendations could be made
  • Obtain feedback to improve labeling, risk communication, public understanding and stewardship

Meeting Location:

Sheraton Silver Spring Hotel, 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.