Safety

Antibacterial Drug Development

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Patient Engagement, Regulatory Submissions + Approvals, Safety

Overview

Increasing bacterial resistance coupled with decreasing research on new antibacterial drugs is creating a crisis that could disproportionately impact our most vulnerable populations, including children and the seriously ill.  

CTTI has created approaches for streamlining antibacterial drug development that will help you design clinical trials that better assess the efficacy and safety of new antibacterial drugs and inform clinical trial planning, recruitment, enrollment, and feasibility. Use CTTI’s recommendations and resources to help combat this complex public health concern.

Projects

ABDD HABP/VABP STUDIES

Learn about CTTI’s prospective, multi-center, observational study of the risk factors for HABP/VABP.

ABDD PEDS TRIALS

Design pediatric antibacterial trials that ensure adequate enrollment, decrease the burden on sites and families, and increase engagement with healthcare providers.

ABDD STREAMLINING HABP/VABP TRIALS

Streamline protocol elements and data collection in HABP/VABP trials to increase enrollment, reduce trial complexity, and optimize operational efficiency.

ABDD UNMET NEED

Read about CTTI’s research findings on patient and physician perspectives and considerations as it relates to using antibacterial drugs developed through streamlined development processes.

Resources

Safety

Antibacterial Drug Development

Increasing bacterial resistance coupled with decreasing research on new antibacterial drugs is creating a crisis that could disproportionately impact our most vulnerable populations, including children and the seriously ill. CTTI...
Safety | Press Releases

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data

Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations announced their collaborative findings from the Implementation of a randomized controlled trial...
Safety | Press Releases

CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single...
Safety | Press Releases

Clinical Trials: Do Participants Feel Safe?

Potential participants in clinical trials may not have a clear understanding of the methods used by researchers to ensure the safety of investigational drugs they are given.
Safety | Press Releases

Clinical Trial Sponsors Fail to Report Results to Participants, Public

Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies...
Safety | Press Releases

Children Underrepresented in Drug Studies

CTTI Project: ABDD Peds Trials The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis...
Safety | Poster Presentations

Streamlining Antibacterial Drug Development Programs To Address Unmet Medical Need: Patient And Provider Attitudes On A Modified Benefit-Risk Calculus

American Thoracic Society International Conference 2016 CTTI Project: Unmet Need Download Presentation (785.09 KB)
Safety | Poster Presentations

Use of Central IRBs for Multi-center Clinical Trials

PRIM&R 2012 Advancing Ethical Research Conference CTTI Project: Single IRB Download Presentation (785.09 KB)
Safety | Poster Presentations

IND Safety Reporting: final results and best practices from the Clinical Trials Transformation Initiative IND Safety Advancement Project

2016 ASCO Annual Meeting CTTI Project: Safety Reporting Download Presentation (785.09 KB)
Safety | Poster Presentations

An Update on the CTTI Use of Central IRBs for Multi-center Clinical Trials Project

PRIM&R 2013 Advancing Ethical Research Conference CTTI Project: Single IRB Download Presentation (785.09 KB)

Formats

Stage of Trial

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data

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CTTI Project: Electronic Healthcare Data

Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib), the first trial to use the U.S. Food and Drug Administration’s (FDA) FDA-Catalyst System network of electronic health data from a diverse group of national health plan data partners.

PDF icon Download Press Release (444.98 KB)

CTTI to Support NIH Workgroup in Developing Evaluation Plan for Single IRB Policy

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CTTI Project: Single IRB

The National Institutes of Health (NIH) has selected the Clinical Trials Transformation Initiative (CTTI) to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.

PDF icon Download Press Release (128.03 KB)