[yoast-breadcrumb]
CTTI Project: Streamlining HABP/VABP Trials
Download Presentation (785.09 KB)
Formats
Workshop on Quality Risk Management: Understanding What Matters
JANUARY 29, 2014 TO JANUARY 30, 2014
CTTI Project: Quality by Design
Meeting Background:
This meeting continued the CTTI workshop series, conducted to evaluate, and allow participants to practice, application of Quality by Design (QbD) principles to clinical trials. The January 2014 workshop focused specifically on applying QbD principles in medical device and diagnostic trials.
Quality by Design emphasizes building quality into a process from the beginning. Applied in clinical development, this approach prospectively examines the design and objectives of trials and identifies “critical to quality” factors (e.g. key data and trial processes such as randomization). Understanding what aspects of a trial are “critical to quality” is essential to subsequently identifying and managing important and likely risks to trial quality. These risks can be managed through modifying trial design, tailoring its implementation, and providing sensible, risk-based oversight. These approaches also have the potential to improve clinical trial efficiency. Focusing on critical aspects of a trial could substantially reduce the burden of clinical trial conduct by relieving sponsors of a perceived obligation to mitigate every potential risk posed by a trial, especially for those activities that minimally affect data quality and human subject protection.
Meeting Objectives:
- Develop understanding of risk-based Quality by Design for clinical trials, from general principles, real-‐world examples, and hypothetical case studies
- Gain confidence in the application of such concepts to clinical trials
- Identify obstacles to the adoption of this approach
- Identify opportunities for dissemination of these principles and practices to a broad array of stakeholders
Meeting Location:
DoubleTree, Bethesda, MD
Meeting Presentations:
- Introduction by Pamela Tenaerts
SESSION I: Landscape, Rationale And Principles
- Quality Risk Assessment and Quality by Design in Clinical Research by Martin Landray
- How US Regulatory Requirements Contribute to Study Quality by James Saviola
- European Perspective on Quality by Angeles Alonso Garcia
- Current issues in device development and approval – Industry perspective by Ted Lystig
- Current issues in device development and approval – Academic perspective by Laura Mauri
- Payor perspective on quality by Louis Jacques
SESSION II: Real‐World Examples
- CoreValve U.S. Pivotal Trial by Ted Lystig
- TASTE: Thrombus aspiration during ST-‐segment elevation myocardial infarction - A multi-center, prospective, registry based randomized clinical trial by Roxana Mehran
- SAFE-PCI: The Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women by Sunil Rao
SESSION III: Providing Guidance
- Principles Document Review by Ann Meeker-O’Connell
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.
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 Presentations:
- Introduction to the Clinical Trials Transformation Initiative (CTTI) by Judith M. Kramer
- Origin of the Project, "Use of Central IRBs for Multi-center Clinical Trials" by Jane Perlmutter*
- Results of Literature Review by Devon Check*
- Early Interviews with Experts by Kathryn Flynn*
- Interviews to Obtain Feedback on Proposed Solutions - Rational for "Considerations Document" by Kevin Weinfurt*
*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.
Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose
AUGUST 23, 2011 TO AUGUST 24, 2011
CTTI Project: Quality by Design
Meeting Background:
At an expert meeting held in October 2010 for the CTTI monitoring project, representatives from a broad cross-section of the clinical trial enterprise—including regulators, government sponsors of clinical research, academicians, industry representatives, patient advocates, clinical investigators, and other interested parties—discussed clinical trial monitoring as one component of an overall quality framework. Panelists and participants agreed that an enlightened approach to ensuring trial quality is needed. Such an approach would apply risk management principles to clinical trials by prospectively identifying critical trial deliverables and important risks to each and then tailoring protocol design and delivery to mitigate those risks. To implement this change, participants agreed that all stakeholders in the clinical trial process must modify their view of risk and have a common understanding of Quality by Design and quality risk management principles. This workshop is the first in a planned series intended to develop Quality by Design and quality risk management principles applicable broadly to clinical trials and development programs, as well as to identify and share best practices for implementing these principles.
Meeting Objectives:
- Develop Quality by Design concepts for the clinical trial process
- Define consensus principles of quality risk management as applied in the drug development lifecycle and in conjunction with Quality by Design concepts
- Review case studies of Quality by Design and quality risk management approaches applied in commercial and academic clinical trial settings, including tools and methodologies and potential best practices
- Discuss methods for evaluating the success of Quality by Design and quality risk management approaches in enhancing the quality and efficiency of clinical development
- Identify mechanisms to disseminate principles and best practices identified during the workshop to a broad array of stakeholders.
Meeting Location:
Hyatt Regency Bethesda, Bethesda, Maryland
Meeting Materials:
Meeting Presentations:
WELCOMING REMARKS
- Introduction by Robert J. Temple
SESSION I: PRINCIPLES FOR BUILDING QUALITY INTO CLINICAL TRIAL DEVELOPMENT
Session Facilitators: Leslie and Peter (lead)
- Monitoring Workstream #3 Key Findings by Briggs Morrison
- Learning from Quality by Design in the Manufacturing Sector by Fergus Sweeney
- Principles of Quality Risk Managementby Beat Widler
SESSION II: REGULATORS' PANEL
Session Facilitators: Fergus and Leslie (lead)
- Regulatory Agencies and Quality in Clinical Trials Risk Adaptive Approach by Kathleen Meeley
- Regulatory Agencies and Quality in Clinical Trials by Pierre Henri Bertoye
- What we can do to Ensure the Quality by Tomoko Osawa
- CDER Perspective: Challenges in Clinical Trials and the Path Forward by Ann Meeker-O'Connell
SESSION III: CASE STUDIES
Session Facilitators: Peter (lead), Fergus, and Ann
Building Quality into Clinical Development: The Academic Perspective
- Quality in clinical trials: What really matters? by Rory Collins
- Building Quality into Clinical Development: ASCEND-HF as a Case Example by Adrian Hernandez and Craig Reist
Building Quality into Clinical Development: The Pharmaceutical Industry Perspective
- Building Quality into Clinical Trials – A Pilot with the FDA by David Nickerson
- Medical Quality by Design: The Journey Continues by Jeff Kasher
- Workshop on Quality Risk Management Making Trials Fit for Purpose by Andrew Lee
- Facilitated Clinical Reviews – An Approach For Better Quality Protocols by Craig Wozniak
- Risk Based Approach – Case Study by Andy Lawton
- Clinical Trial Quality by Design Case Study − A Small Company Experience by Lynn Seely
Building Quality into Clinical Development: Outsourcing
- CRO Point of View by Regina Freunscht
- Building Quality into Clinical Development: Outsourcing by Ken Getz
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.
Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials
JUNE 15, 2017 TO JUNE 16, 2017
CTTI Project: Digital Health Trials
Meeting Objectives
- Present findings from evidence gathering activities
- Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile devices for objective data capture in clinical trials. Specifically,
- possible solutions to key data challenges
- scientific and technological considerations
- Identify the change agents who will drive adoption of mobile devices for capturing objective data in clinical trials, including for the purposes of regulatory submission
- Describe what products CTTI should develop to equip change agents to include mobile devices for data capture in clinical trials, including for the purposes of regulatory submission
Meeting Location:
DoubleTree by Hilton Hotel Crystal City 300 Army Navy Drive | Arlington, VA
Meeting Presentations:
1. The CTTI MCT Mobile Devices Project and Meeting Goals by Jennifer Goldsack
2. Human Adaptation to Information: A Challenge for the Next Decade by Robert Califf
3. Mobile Clinical Trials and CDRH's Regulation of Devices by Dharmesh Patel
4. Recommendations from CTTI’s MCT Novel Endpoints Project by Jennifer Goldsack
5. Presentation of Evidence on Data Challenges (Panel Presentation)
6. Presentation of Evidence on Scientific and Technological Issues (Panel Presentation)
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 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
- Can we reduce complexity and safety data collection to improve the quality of the data and inferences we make? by Charles Knirsch
- Challenges in data collection for HABP/VABP trials: Investigator’s perspective by Richard Wunderink
- Data Collection in HABP/VABP Trials: Regulatory Perspective by Sumati Nambiar
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
- Safety data collection in late stage premarket and post-approval clinical investigations by Patrick Archdeacon
- Managing safety data in multi-regional trials by Chris Wohlberg
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
- Using QbD for data collection planning by Mark Behm
- Guiding principles for efficient data collection- 20 years of cardiovascular outcomes trials by Lisa G. Berdan
- Breakout discussion instructions by Sabrina Comic-Savic
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.
Quality Objectives of Monitoring
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 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.
Meeting on the Long-Term Safety and Efficacy of Extended-Release and Long-Acting Opioid Analgesics for Chronic Pain
AUGUST 12, 2013 TO AUGUST 13, 2013
Meeting Background:
The purpose of this meeting, hosted by CTTI, is to facilitate a broad scientific discussion about optimal ways to generate additional evidence to help inform the safe and effective use of extended-release and long-acting opioid analgesics.
Meeting Objectives:
- Engage multiple stakeholders in discussions around approaches to develop more evidence on the long-term safety and efficacy of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain
- Review and discuss a proposed study to evaluate the long-term efficacy of opioids for the treatment of chronic non-cancer pain
- Discuss strategies to assess the long-term safety of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain
Meeting Location:
Sheraton Silver Spring Hotel, Silver Spring, MD
Meeting Presentations:
- Welcoming Remarks by Pamela Tenaerts and Rachel Sherman
Session 1: Evidence for the Efficacy of Opioid Analgesics for Chronic Pain
- Review of the Evidence for the Efficacy and Effectiveness of Opioid Analgesics for Chronic Pain by Jane Ballantyne
Session 2: Review of Proposed Efficacy Study
- Overview of Efficacy Protocol Synopsis by Robert Califf
- Proposed Protocol Synopsis (PDF)
Session 3: Continued Discussion of Efficacy Study
Session 4: Existing Data Sources to Evaluate Opioid Analgesic Safety
- Monitoring Opioid Analgesic Abuse and Overdose in the United States by Christopher M. Jones
- Postmarketing Surveillance of Prescription Drug Abuse by Richard Dart
- Harnessing National Data Sets: National Survey on Drug Use and Health (NSDUH) and VA Data by William Becker
- Using Integrated Health Plan EMR Data to Evaluate Outcomes Associated with Clinical Services for the Treatment of Non-Malignant Chronic Pain by Lynn DeBar
Session 5: Gathering Additional Evidence on Opioid Analgesic Safety
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 Materials:
Day 1
- Session I: DHT-Derived Novel Endpoint Development: Current Landscape
- Session II: DHT-Derived Endpoints in Trials: The Reality vs. the Idea
- Mentimeter Results - 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.