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CTTI

Clinical Trials Transformation Initiative

Publications

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

Posted on March 8, 2017February 6, 2025 by Hannah Faulkner

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

Posted in Investigator Community, Investigator Community, Publications, Related: Investigator Community, Site Planning, Study Operations

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

Posted on December 15, 2016February 11, 2025 by Hannah Faulkner

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

Posted in Publications, Related: Safety Reporting, SAE Reporting, Safety, Safety Reporting, Study Operations

Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees

Posted on December 13, 2016January 31, 2025 by Hannah Faulkner

Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees

Posted in Data Monitoring Committees, Data Monitoring Committees, Ensuring Quality, Publications, Related: Data Monitoring Committees, Safety, Study Operations

Understanding the functions and operations of data monitoring committees: Survey and focus group findings

Posted on November 25, 2016January 31, 2025 by Hannah Faulkner

Understanding the functions and operations of data monitoring committees: Survey and focus group findings

Posted in Data Monitoring Committees, Data Monitoring Committees, Ensuring Quality, Publications, Related: Data Monitoring Committees, Safety, Study Operations

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis

Posted on November 10, 2016January 29, 2025 by Hannah Faulkner

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis

Posted in ABDD Unmet Need, Antibacterial Drug Development-Unmet Need, Ensuring Quality, Publications, Regulatory Submissions + Approvals, Related: ABDD Unmet Need, Safety, Study Design

Supplement: Facilitating Antibacterial Drug Development in a Time of Great Need

Posted on August 1, 2016November 21, 2024 by Hannah Faulkner

Supplement: Facilitating Antibacterial Drug Development in a Time of Great Need

Posted in Antibacterial Drug Development-Streamlining HABP/VABP Trials, Improving Population Health, Publications, Related: ABDD Streamlining HABP/VABP

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Posted on August 1, 2016January 15, 2025 by Hannah Faulkner

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Posted in ABDD Streamlining HABP/VABP, Antibacterial Drug Development-Streamlining HABP/VABP Trials, Publications, Related: ABDD Streamlining HABP/VABP

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

Posted on August 1, 2016January 15, 2025 by Hannah Faulkner

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

Posted in ABDD Streamlining HABP/VABP, Antibacterial Drug Development-Streamlining HABP/VABP Trials, Publications, Related: ABDD Streamlining HABP/VABP

Facilitating Antibacterial Drug Development in a Time of Great Need

Posted on August 1, 2016January 15, 2025 by Hannah Faulkner

Facilitating Antibacterial Drug Development in a Time of Great Need

Posted in ABDD Streamlining HABP/VABP, Antibacterial Drug Development-Streamlining HABP/VABP Trials, Publications, Related: ABDD Streamlining HABP/VABP

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Posted on August 1, 2016January 15, 2025 by Hannah Faulkner

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Posted in ABDD Streamlining HABP/VABP, Antibacterial Drug Development-Streamlining HABP/VABP Trials, Publications, Related: ABDD Streamlining HABP/VABP

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