CTTI Meetings

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Master Protocol Expert Meeting

CTTI Project: Master Protocol Studies

Meeting Overview:
The purpose of the meeting was to explore and develop strategies to address common challenges related to the design and implementation of master protocols, including:

Enhancing the Incorporation of Patient Perspectives in Clinical Trials

CTTI Project:

 

Meeting Overview:
CTTI and the FDA held this workshop in order to:

CTTI’s Mobile Technologies Event

CTTI Project: Mobile Technologies

CLICK HERE for the meeting agenda.

Meeting Objectives:

Share practical examples and best practices for:

Real-World Data and Evidence in the Evaluation of Medical Products

CTTI Project: Real-World Data

 

Stakeholder Perceptions of the Use of Mobile Technology in Clinical Trials

CTTI Project: Engaging Patients and Sites

 

Qualifying Investigators to Conduct Sponsored Clinical Trials

CTTI Project: Investigator Qualification

 

Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?

CTTI Project: Single IRB

 

Legal & Regulatory Issues Affecting the Adoption of Mobile Clinical Trials

CTTI Project: Decentralized Clinical Trials

 

Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials

CTTI Project: Mobile Technologies

 

Strengthening the Investigator Community Project

CTTI Project: Investigator Community

 

Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

CTTI Project: Novel Endpoints

 

Improving Pediatric Trials in Antibacterial Drug Development | No Sick Child Left Behind

CTTI Project: Peds Trials

 

A Brave New World: Registry-Based Clinical Trials

CTTI Project: Registry Trials

 

The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward

CTTI Project: Unmet Need

CLICK HERE for the meeting summary.

CTTI Recruitment Project Expert Meeting

CTTI Project: Recruitment

 

CTTI Data Monitoring Committees Project Expert Meeting

CTTI Project: Data Monitoring Committees (DMCs)

 

Expert Meeting: CTTI IND Safety Advancement Project

CTTI Project: Safety Reporting

 

CTTI Informed Consent Project Expert Meeting

CTTI Project: Informed Consent

 

ABDD HABP/VABP Pilot Study Workshop

CTTI Project: HABP/VABP Studies

 

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.

 

Patient Groups and Clinical Trials Expert Meeting

CTTI Project: Patient Groups & Clinical Trials

 

Statistical Issues Think Tank II

CTTI Project: Unmet Need

 

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

CTTI Project: Single IRB

 

Expert Meeting on Good Clinical Practice (GCP) Training: Current Practices and Challenges

CTTI Project: Investigator Qualification

 

Workshop on Quality Risk Management: Understanding What Matters

CTTI Project: Quality by Design

 

Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials

CTTI Project: Streamlining HABP/VABP Trials

CLICK HERE for the meeting agenda.
CLICK HERE for the list of meeting participants.

Antibacterial Drug Development Working Group Webinar

CTTI Project: Streamlining HABP/VABP Trials

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.

Meeting on the Long-Term Safety and Efficacy of Extended-Release and Long-Acting Opioid Analgesics for Chronic Pain

CTTI Project: Long-Term Opioid Data

 

Pregnancy Testing in Clinical Trials Expert Meeting

CTTI Project: Pregnancy Testing

 

Expert Meeting on Large Simple Trials (LSTs)

CTTI Project: Large Simple Trials

 

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.
CLICK HERE for the meeting summary.

Antibacterial Drug Development: Developing a Pilot Protocol for Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia

CTTI Project: Streamlining HABP/VABP Trials

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.

Understanding Issues in Antibacterial Drug Development Webinar

CTTI Project: Streamlining HABP/VABP Trials

All of the attendees of the April 22 - 23, 2013 Expert Meeting where invited to attend this webinar.

Workshop on Quality Risk Management: Understanding What Matters

CTTI Project: Quality by Design

 

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

CTTI Project: Unmet Need

 

Workshop on Quality Risk Management: Understanding What Matters

CTTI Project: Quality by Design

CLICK HERE for a list of meeting participants.
CLICK HERE for the meeting agenda.

CTTI Antibacterial Drug Development: Statistical Issues Think Tank Meeting

CTTI Project: Unmet Need

CLICK HERE for a list of meeting attendees.

Use of Central IRBs for Multi-center Clinical Trials

CTTI Project: Single IRB

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.

Expert Meeting: IND Safety Assessment and Communication

CTTI Project: Safety Reporting

 

Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose

CTTI Project: Quality by Design

 

Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach

CTTI Project: Quality by Design

 

Expert Meeting: Adverse Event Reporting

CTTI Project: Safety Reporting

 

Expert Meeting on Site Metrics for Study Start-Up

CTTI Project: Site Metrics

 

CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.

Meeting Background

Quality Objectives of Monitoring

CTTI Project: Quality by Design

 

CLICK HERE for the summary.
CLICK HERE to view the Final Report.