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CTTI Project: HABP/VABP Studies
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Novel Endpoints
Embedding Clinical Trials within Registries: How Feasible?
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CTTI Project: Registry Trials
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Hospital Associated and Ventilator Acquired Bacterial Pneumonia in Infants and Children
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CTTI Project: HABP/VABP Studies
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A Collaboration to Facilitate the Development of Antibacterial Agents for Unment Need: Streamlining Clinical Trial Protocols
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CTTI Project: Streamlining HABP/VABP Trials
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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.
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.
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.
Understanding Issues in Antibacterial Drug Development Webinar
APRIL 18, 2013
CTTI Project: Streamlining HABP/VABP Trials
Meeting Background:
This webinar provides a background and overview of the issues and many years-long discussions in antibacterial drug development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
Meeting Objectives:
This webinar served to familiarize the diverse group of participating experts with detailed information on this research topic as a preamble to the HABP/VABP pilot study protocol workshop that occurred in Bethesda on April 22 - 23, 2013.
Meeting Location:
Online
All of the attendees of the April 22 - 23, 2013 Expert Meeting where invited to attend this webinar. CLICK HERE for a list of meeting invitees.
Meeting Presentation:
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.
Articles of Interest
- Duke-Margolis Paper Details Strategies to Treat COVID-19
- Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both (The New England Journal of Medicine)
- Complete, Rapid Reporting of Clinical Trials: A Necessary Component of the Pandemic Response (Medium)
Master Protocol COVID Treatment Resources
- Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
- I-SPY COVID Trial
- RECOVERY - Randomised Evaluation of COVID-19 Therapy
- REMAP-CAP: A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia
- “Solidarity” Clinical Trial for COVID-19 Treatments
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 Presentations:
- Introduction to the Clinical Trials Transformation Initiative (CTTI) by Pamela Tenaerts
- Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
- Qualitative Interview Findings by Jack Sheehan
- Use of RWD in Pre-Study Planning and Study Set Up Session Introduction by Jane Perlmutter
- Use of RWD in Pre-Study Planning & Study Set up: Health Plan Perspective by Kevin Haynes
- Use of RWD in Pre-Study Planning & Study Set up: Manufacturer Perspective by Ben Gutierrez
- Using the Cystic Fibrosis Patient Registry to Support Clinical Trials Planning by Aliza Fink
- Use of RWD in Study Recruitment and Enrollment: EHR Enabled Platform by James Hamrick
- Patient & Site Identification Using an EMR Data System by David Thompson
- Real-World Treatment Responses in Advanced NSCLC Patient Subgroups by Michael Lu
- Real World Data Use in Embedded Pragmatic Clinical Trials by Sarah Leatherman
- Use of Real-World Data within ADAPTABLE, The Aspirin Study by Brad Hammill
- 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.