CTTI Meetings

Home Briefing Room CTTI Meetings

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

CTTI Project: Informing the Update of ICH E6

Meeting Agenda

Meeting Materials: 

Day 1

Master Protocol Expert Meeting

CTTI Project: Master Protocol Studies

Meeting Overview:
The purpose of the meeting was to continue to drive the development of publicly available resources to support the successful design and implementation of master protocol studies. Specific meeting objectives included the following:

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: Digital Health 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: Digital Health 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.