Safety

Safety

Ensuring the safety and protection of our study participants is without question the highest priority of any research endeavor, and at CTTI, we understand the complexities involved. Thoroughly and efficiently incorporating human research protection goes beyond risk mitigation; it demands timely and accurate safety data reporting, appropriate IRB and informed consent practices, and continuous communication with data monitoring committees.

CTTI's patient safety resources provide comprehensive solutions, featuring practical tips, best practices, and expert guidelines to help you navigate these complexities.

Topic 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

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 | 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 | 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)

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Stage of Trial