Publications

Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach

in Journal of the Pediatric Infectious Diseases Society

CTTI Project: Peds Trials

Assessing the Financial Value of Patient Engagement

in Therapeutic Innovation & Regulatory Science (TIRS)

CTTI Project: Patient Groups & Clinical Trials

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative

in Clinical Trials

CTTI Project: Data Monitoring Committees (DMCs)

To view the original recommendations document referenced in this publication, click here.

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

in Contemporary Clinical Trials Communications

CTTI Project: Investigator Community

How Public–Private Collaborations Are Driving Solutions to the Antibacterial Drug Development Crisis

in Clinical Infectious Diseases

CTTI Project: Streamlining HABP/VABP Trials

This peer-reviewed publication is part of the supplement, Facilitating Antibacterial Drug Development in a Time of Great Need, released in Clinical Infectious Diseases.

Facilitating Antibacterial Drug Development in a Time of Great Need

in Clinical Infectious Diseases

CTTI Project: Streamlining HABP/VABP Trials

This peer-reviewed supplement in the journal Clinical Infectious Diseases features collaborative and innovative approaches by CTTI and others to address this pressing public health concern and speed new treatments to patients. The supplement includes 8 articles and was developed in parallel with the release of our Streamlining HABP/VABP Trials Recommendations.

The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

in Statistics in Biopharmaceutical Research

CTTI Project: Safety Reporting

Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey

in Applied Clinical Trials

CTTI Project: Recruitment

Compliance with Results Reporting at ClinicalTrials.gov

in New England Journal of Medicine

CTTI Project: State of Clinical Trials

*Click here to view the the dataset used for this manuscript. (The first worksheet in this Excel file contains the description and data dictionary; the second worksheet contains the data for the 13,327 studies and all of the variables used in the analysis.)

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

in Therapeutic Innovation & Regulatory Science

CTTI Project: Safety Reporting

An Analysis of Registered Clinical Trials in Otolaryngology from 2007 to 2010

in Otolaryngology -- Head and Neck Surgery

CTTI Project: State of Clinical Trials

Cycle Time Metrics for Multisite Clinical Trials in the United States

in Therapeutic Innovation & Regulatory Science

CTTI Project: Site Metrics

Clinical Trials: Rethinking How We Ensure Quality

in Drug Information Journal

CTTI Project: Quality by Design

The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

in PLoS ONE

CTTI Project: State of Clinical Trials

*The Editorial Board of the 2013 IMIA Yearbook of Medical Informatics lists this publication as one of the best papers published in 2012 in the Clinical Research Informatics subfield of Medical Informatics

Impediments to Clinical Research in the United States

in Clinical Pharmacology & Therapeutics

CTTI Project: State of Clinical Trials

The Clinical Trials Transformation Initiative (CTTI)

in Annali dell'Istituto Superiore di Sanità

CTTI Project: State of Clinical Trials

The ClinicalTrials.gov Results Database - Update and Key Issues

in The New England Journal of Medicine

CTTI Project: State of Clinical Trials

The Clinical Trials Transformation Initiative (CTTI): Challenging the Status Quo

in Monitor

CTTI Project: State of Clinical Trials

The Monitor was a private ACRP publication and this article is not publicly available at this time.