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CTTI Project: Registry Trials
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Study Design
Framework for Aligning Research Sponsors and Patient Groups on Methods for Engagement
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CTTI Project: Patient Group Engagement
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A CTTI Survey of Current Monitoring Practices
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CTTI Project: Quality by Design
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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.
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.
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.
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 Presentations:
- Introduction to the Clinical Trials Transformation Initiative and the ABDD Program by Pamela Tenaerts
- Project Overview and Scope by Jamie Roberts
- Current Landscape and Pipeline of Antibacterial Products by Vance Fowler
- Streamlined Development Approaches by Joseph Toerner
- Findings: Perspectives of Patients, Caregivers and Healthy People by Diane Bloom
- Findings: Perspectives of Providers and Investigators by Thomas Holland
- Focus Group Themes and Questions for Consideration by Stephen Mikita
- Closing by Pamela Tenaerts, Rosemary Tiernan & Jamie Roberts
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 Presentations:
DAY 1 – JANUARY 21 , 2015
- Welcoming Remarks and Overview Dr. by Pamela Tenaerts and Bray Patrick-Lake
- Success from Start to Finish: Multi-Stakeholder Engagement by William Tunno
- Key Findings from CTTI’s Project on Best Practices for Effective Engagement with Patient Groups around Clinical Trials by Wendy Selig
- The Learning Collaborative | A Unique Government - Disease Philanthropy - Academia Collaboration by Dr. Scott Weir and Dr. G. Sitta Sittampalam
- Therapy Acceleration Program® (TAP): filling a “gap” in our research programs by Jun Xu
- FARA Example of Public-Private Partnership by Ron Bartek
- Opportunities for Engagement by Joel Beetsch
- Regulatory Restrictions on “Promotion” of Investigational Products by Carla Cartwright
- Understanding Clinical Trial Recruitment Rules: Debunking Myths by Richard Klein
- Conflicts of Interest – Real and Apparent Issues by Ron Bartek
- Navigating the Rules of Engagement: In-house counsel perspective by Rebecca Prince
- Breakout Session 2 Framework
DAY 2 – JANUARY 22 , 2015
- The Cost of Clinical Trial Delays by Ken Getz
- What Industry is Measuring Around Patient Group Partnerships by David Leventhal
- Impact of Patient Engagement on Project Valuation by Dr. Bennett Levitan
- Progress Through Partnership: Integrating Stakeholders into the Clinical Research Process by Dr. Petra Kaufmann
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.
Statistical Issues Think Tank II
NOVEMBER 19, 2014
CTTI Project: Unmet Need
Meeting Objectives
- To provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
- To discuss ongoing challenges in the development and adoption of innovative methods
- To generate strategies to propel antibacterial drug development forward.
Meeting Location:
Bethesda North Marriott Hotel & Conference Center, Bethesda, MD
Meeting Presentations:
Session 1: Current status of drug development and ongoing challenges
- Introduction to CTTI's Clinical Trials Transformation Initiative: Antibacterial Drug Development Project by Lisa M. LaVange
- Summary of Regulatory Standards and Guidances by Joseph Toerner
- Summary of unmet need guidance and statistical challenges by Daniel B. Rubin
- Application of Pharmacokinetics/Pharmacodynamics in New Anti-Infective Drug Development: Current Challenges and Future Perspectivesby Seong Jang
- Statistical Considerations for Antibiotic Drug Development by Aaron Dane
Session 2: Current research and additional opportunities for the future
- Discordant MIC Analysis: Testing for Superiority within a Non-inferiority Trial by Dean Follmann, Erica BriDain, and John Powers
- Hierarchical nested trial design (HNTD) for new antibacterial drugs in patients with emerging bacterial resistance by Thamban Valappil and Mohammad Huque
- Response Adjusted for Duration of Antibiotic Risk (RADAR) by Scott Evans
- Some Proposals in the Analysis of Antibacterial Drug Trials by Margaret Gamalo-Siebers and Ram C. Tiwari
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 Presentations:
Day 1
- Welcome by Sara Calvert
- Origin and Rationale of the Project, “Developing Rational Guidance for Pregnancy Testing in Clinical Trials” by Evan R. Myers
- Why do we worry about pregnancy testing? – Teratogens and Teratogenic Risk by Melissa S. Tassinari
- The Analytical & Clinical Complexities of Measuring hCG by Ann M. Gronowski
- What does having a FDA cleared pregnancy test mean? by Denise Johnson-Lyles
- Pharmaceutical Industry Process for Selecting a Pregnancy Testing Protocol by Sheila Ronkin
- Summary of Results from CTTI Pregnancy Testing in Clinical Trials Survey by Evan Myers
- Modeling Approach Background and Initial Simulation Results - Potential Resources/Tools to Guide Selection of Pregnancy Testing Protocols by Evan Myers
Day 2
- Summary of Day 1 Recommendations for Designing and Evaluating Pregnancy Testing Protocols by Evan Myers
- Next Steps by Evan Myers
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.