Projects

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.

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.

Antibacterial Drug Development: Developing a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

APRIL 22, 2013 TO APRIL 23, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek solutions for challenges in study design and conduct of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) studies by applying the Quality by Design (QbD) principles.

Meeting Location:

Bethesda, MD

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Session 1: The Challenges of HABP/VABP Trials

Session 2: How can QbD be used to address the challenges in HABP/VABP trials?

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.

CTTI Antibacterial Drug Development: Statistical Issues Think Tank Meeting

AUGUST 20, 2012

CTTI Project: Unmet Need

Meeting Background:

A CTTI-hosted Statistical Issues Think Tank Meeting was convened to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful for antibacterial drug development programs.

Meeting Location:

Bethesda Hyatt Regency, Bethesda, MD

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentation:

CTTI Statistics Think Tank for Anti-Bacterial Drug Development by Lisa LaVange

Resulting Publications:

1) Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance

On June 23, 2014, Statistics in Medicine published an article by Huque et al. that describes a novel clinical trial model to address the increased prevalence of antibiotic-resistant bacterial infections. This paper resulted from the CTTI-hosted Statistical Issues Think Tank Meeting that author Mohammad Huque attended.

2) The Role of Statistics in Regulatory Decision Making

In February, 2014, this peer-reviewed article was published in Therapeutic Innovation & Regulatory Science. This paper resulted from the CTTI-hosted Statistical Issues Think Tank Meeting where author Lisa M. LaVange, PhD, attended and presented. In this publication, LaVange concludes:

This article presents the author’s view of the important role that statisticians play in regulatory decision making, beginning with a broad overview of current office initiatives, including the development of guidance documents and a recent push for open and transparent collaboration with industry on methods development. Several recent examples are provided to illustrate the impact that statisticians can have on regulatory decisions through the use of strategic quantitative thinking. Also discussed are areas where it is believed that innovative statistical solutions or greater clarity on existing approaches is still needed.

3) Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products

On August 5, 2013, the Journal of Pharmaceutical Statistics published an article by Gamalo et al. that describes a Bayesian approach for the design and analysis of active comparator trials used in the development and market approval of antibacterial drugs. This work was presented in part at the CTTI-hosted Statistical Issues Think Tank Meeting.

“The CTTI Statistics Think Tank, a collaborative initiative with the FDA/CDER Anti-Bacterial Drug Development Task Force, was held in August, 2012 and provided an excellent opportunity for leading statisticians from academia, government, and industry to discuss innovative approaches for accelerating the development of new antibiotics. This article presents a comprehensive Bayesian approach to non-inferiority trials and represents but one of several approaches that were discussed at the Statistics Think Tank meeting. We look forward to additional research being published from the ideas generated at that meeting.” said Lisa LaVange Director of Biostatistics, Food and Drug Administration.

The Bayesian approach may allow for use of information from sources that include observational studies and early phase trials on the effect of the active comparator for study design. This approach may aid in reducing large sample size requirements and decrease study durations for antibacterial agents that enter late-stage clinical development.

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.

CTTI Data Monitoring Committees Project Expert Meeting

JULY 28, 2015 TO JULY 29, 2015

CTTI Project: Data Monitoring Committees (DMCs)

Meeting Objectives

  • Present findings and conclusions from the project survey and focus groups
  • Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations

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.

CTTI Informed Consent Project Expert Meeting

MARCH 10, 2015 TO MARCH 11, 2015

CTTI Project: Informed Consent

Meeting Objectives

  • Present findings and conclusions from the project literature review and expert interview series
  • Solicit feedback and develop consensus on proposed recommendations to enhance the informed consent process

Meeting Location:

DoubleTree by Hilton Hotel Washington DC, 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.

Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach

OCTOBER 13, 2010 TO OCTOBER 14, 2010

CTTI Project: Quality by Design

Meeting Background:

The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify effective and efficient methods to monitor clinical trials. In seeking to identify how best to ensure the reliability of study results and the protection of trial participants, the project team has recognized that quality cannot be “inspected into” a trial but rather must be incorporated from the outset in the trial’s protocol design and operational conduct. To be effective, monitoring should be one component of an overall quality framework that allows potential issues to be identified and addressed as early as possible.

Meeting Objectives:

  • Describe, discuss, and evaluate novel approaches to clinical trial oversight
  • Propose an integrated model of quality management that will promote more efficient approaches to design, conduct and oversight of clinical trial
  • Identify the critical aspects of clinical trials that should be the focus of risk-based approaches to creating quality systems

Meeting Location:

Bethesda Marriott Suites, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Defining the Underlying Principles of Quality in Clinical Trials

Approaches to Risk-Based Quality Management

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.

Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?

NOVEMBER 14, 2017

CTTI Project: Single IRB

Meeting Objectives:

  • Review upcoming NIH policy and Common Rule changes regarding single IRB review as well as existing FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials.
  • Discuss the remaining gaps in knowledge, guidance and tools for implementing a single IRB review model.
  • Propose solutions regarding implementation of single IRB model for federally funded (e.g., NIH-sponsored), and for FDA-regulated drug and device, multicenter clinical studies.

Meeting Location:

DoubleTree by Hilton Hotel Silver Spring, 8727 Colesville Rd., Silver Spring, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to CTTI and the Single IRB Project by Sara Calvert
  2. NIH Single IRB Policy by Petrice Brown-Longenecker
  3. Changes to the Common Rule for Single IRB by Lyn Lau
  4. FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials by Bridget Foltz
  5. Resources from the CTTI Single IRB Projects by Cynthia Hahn
  6. SMART IRB Platform Overview by Petra Kaufmann
  7. SMART IRB Exchange NIH Trial Innovation Network by Emily Serdoz
  8. AAHRPP Proposed Single IRB Review Standard by Robert Hood

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.

CTTI Recruitment Project Expert Meeting

NOVEMBER 09, 2015 TO NOVEMBER 10, 2015

CTTI Project: Recruitment

Meeting Objectives

  • Present findings from the CTTI Recruitment Project’s evidence gathering
  • Obtain stakeholder perspectives and critical feedback on draft considerations for more effective recruitment planning
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for moving recruitment planning upstream and achieving culture change
  • Identify implementation barriers to achieving change
  • Develop consensus across multiple stakeholder perspectives on the mechanisms for overcoming barriers to achieving change

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.