CTTI

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 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:

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

Meeting Presentation:

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

Resulting Publications:

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’s Mobile Technologies Event

JULY 16, 2018

CTTI Project: Digital Health Trials

Meeting Objectives:

Share practical examples and best practices for:

Selecting mobile technologies for data capture that are appropriate to the trial.
Capturing complete, attributable, and high-quality data.
Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
Designing and executing a protocol that uses mobile technologies for data capture.
Preparing for FDA submission and inspection.

Meeting Location:

FDA White Oak Campus 10903 New Hampshire Ave., Silver Spring, MD

CLICK HERE for the meeting agenda.

Meeting Materials:

Introduction to CTTI by Annemarie Forrest

Introduction to the Mobile Clinical Trials Project by Jen Goldsack

Session I: Technology Selection

Session II: Data Collection, Analysis, and Interpretation

Session III: Data Management

Session IV: Optimizing Protocol and Design Execution

Session V: Supporting FDA Submission and Inspection

Session VI: Mobile Technologies in Perspective

Additional 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.

Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States

JUNE 12, 2014 TO JUNE 13, 2014

CTTI Project: Single IRB

Meeting Objectives:

Discuss practices, implementation strategies, and solicit additional suggestions for increasing the use of central IRBs for multi-center clinical trials
Present findings from the CTTI Central IRB Advancement project’s collection of IRB authorization agreements and standard operating procedures
Obtain additional feedback to refine proposed IAA template and tools

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Presentations:

DAY 1 – JUNE 12 , 2014

Welcoming Remarks by Bray Patrick-Lake
Landscape of the Use of Central Institutional Review Boards for Multi-center Clinical Trials by Soo Bang
Academic Institution Example: Reliance on Independent IRBs for Multi-center Clinical Trials by David Borasky
Federal Central IRB Example: The NCI CIRB Initiative by Jacquelyn Goldberg
Industry Sponsor Example: Sponsor’s Experience - Challenges of Implementation by Soo Bang
IRB Authorization Agreement Data Collection by Cynthia Hahn

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.

Antibacterial Drug Development Working Group Webinar

AUGUST 29, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The Clinical Trials Transformation Initiative hosted an Antibacterial Drug Development Program Working Group Webinar on Aug 29, 2013 to provide an update on the program, and to make further progress on developing streamlined elements for a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). This webinar was a follow-up to a recently held workshop last April. The agenda for this collaborative effort included an update from the Foundation of the NIH (FNIH) HABP/VABP Working Group, followed by a lively discussion that focused on aspects of study design and endpoints. As with prior meetings, a variety of stakeholders attended the workshop, including academia, clinical experts, patient advocates, regulators, representatives from pharmaceutical companies, and others involved in the clinical research enterprise. The working group will incorporate the insight gained into the development of recommendations for elements for a Pilot Protocol for HABP/VABP studies.

"It is reassuring to see the progress made since the CTTI expert meeting held last October. A broader range of stakeholders has helped each person consider new possibilities in a much more open way, and should lead to a pilot protocol with better results that everyone can accept and act upon. I look forward to pushing the envelope further for all HABP/VABP patients, including a serious discussion of when superiority trials can be considered." Said Deborah Collyar, President, Patient Advocates In Research (PAIR) who attended the webinar.

Meeting Location:

Online

Meeting Materials:

Meeting Presentations:

CTTI Antibacterial Drug Development Program Update by Pamela Tenaerts
FNIH Update by George Talbot
HABP/VABP Patient Outcomes from Previously Conducted Trials by Daniel Rubin

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.

Anti-Bacterial Drug Development: Issues in the Design of Trials in Patients with Unmet Need and in Patients with Hospital-Acquired and Ventilator Associated Bacterial Pneumonia

OCTOBER 11, 2012 TO OCTOBER 12, 2012

CTTI Project: ABDD Unmet Need

Meeting Background:

With rising antibiotic resistance becoming an issue of global concern, the Clinical Trials Transformation Initiative (CTTI) convened a 2-day Antibacterial Drug Development Workshop on October 11-12, 2012 in Crystal City, VA. The workshop is part of a series of expert meetings to explore approaches for accelerating the development of new antibacterial drugs. The two topics of focus for this meeting were exploring a new paradigm for antibacterial drug development in areas of unmet need, and for the treatment of patients with pneumonia that develops in the hospital or while on a ventilator. This workshop followed a think tank on statistical issues that was held on August 20, 2012, in Bethesda, MD, also hosted by CTTI.

There is an urgent need to develop new antibacterial drugs to treat patients with infections caused by bacteria that are resistant to available antibiotics. Antibiotic resistance has been increasing, creating an unmet public health need. This workshop was held in collaboration with FDA’s newly formed Antibacterial Drug Development Task Force within the Center for Drug Evaluation and Research (CDER).

The purpose of the workshop was to understand the challenges in the development of new antibacterial drugs for the treatment of patients with unmet medical need (e.g., patients with multi-drug resistant bacterial infections, who have limited or no options for treatment) and to identify potential solutions that would accelerate the drug development process. Novel endpoints and possible solutions to challenges in trial design for the development of new antibacterial drugs that treat patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP and VABP) were also explored. A broad range of stakeholders participated in the meeting, including experts from academic institutions, hospitals, pharmaceutical industry, government, and patient advocacy groups.

“The workshop provided an excellent opportunity to discuss new development pathways for antibiotic drugs targeting infections for which we urgently need new antibiotic therapies. Our collaboration with CTTI on this work is part of the CDER Antibacterial Drug Development Task Force’s efforts to accelerate the development of new antibiotics to address critical patient needs”, said Edward Cox, MD, Director of the CDER’s Office of Antimicrobial Products.

Meeting Objectives:

The goal of the first day of the workshop was to define potential pathways and explore new paradigms to accelerate the development of new antibacterial drugs that would address unmet medical need, including discussing acceptable levels of uncertainty related to the risks and benefits of such treatments. The second day focused on issues in clinical trial design including endpoints and operational efficiencies specific to the development of antibacterial drugs for treating patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).

Meeting Location:

Sheraton Crystal City Hotel, Arlington, VA

Meeting Materials: