Enhancing Clinical Trials: CTTI Collaborative Initiatives
CTTI (Clinical Trials Transformation Initiative) is a public-private partnership between Duke University and the FDA, focusing on improving the quality and efficiency of clinical trials. With a multi-stakeholder approach, CTTI involves various entities such as clinical investigators, patients, government agencies, and industry partners. The initiative engages in diverse activities including patient engagement, site quality, novel trial designs, ethics, mobile technologies, and real-world data utilization. CTTI provides recommendations and resources to enhance patient involvement, streamline recruitment processes, improve trial design, and ensure ethical standards. Recognized for its significant contributions, CTTI plays a vital role in advancing clinical research practices.
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Presentation Transcript
Introduction to CTTI Annemarie Forrest
Public-Private Partnership Co-founded by Duke University & FDA Involves all stakeholders - Approx. 80+ members - Participation of 400+ more orgs MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials
Multi-Stakeholder Collaboration Clinical Investigators Patients, Caregivers & Patient Advocacy Groups Government & Regulatory Agencies Better Streamlined Fit for purpose Clinical Trials table Everyone is an equal partner at the Industry (pharma, bio, device, CRO, & tech) Academia Trade & Professional Orgs IRBs
CTTI Membership *Version: August 06, 2019
CTTI Activities Quality Patient Engagement Investigators & Sites Quality by Design Informing ICH E6 Renovation Diversity Analysis of ClinicalTrials.gov Recruitment Planning for Pregnancy Testing State of Clinical Trials Report Monitoring Patient Groups & Clinical Trials Patient Engagement Collaborative Investigator Community Investigator Qualification Site Metrics Novel Clinical Trial Designs Ethics & Human Research Protection Mobile Clinical Trials Novel Endpoints Mobile Technologies Decentralized Clinical Trials Engaging Patients and Sites Real-World Data Registry Trials Master Protocols Antibacterial Drug Development Large Simple Trials Using FDA Sentinel for Trials Single IRB Data Monitoring Committees Informed Consent Safety Reporting
CTTI Recommendations and Resources Quality Patient Engagement Investigators & Sites Patient Groups Investigator Site Community Create better protocols with Involve Patient Groups as equal partners Strengthen the Investigator Quality by Design (QbD) Quality by Design (QbD) Move Recruitment planning upstream Create Pregnancy Testing plans for improved clinical trials Investigator Site Community Site Community Improve Investigator Qualification & reduce GCP Training inefficiencies Recruitment Investigator Qualification Investigator Qualification Pregnancy Testing GCP Training Novel Clinical Trial Designs Ethics & Human Research Protection Mobile Clinical Trials Novel Endpoints Registries Pathways for developing Novel Use Registries to conduct more efficient clinical trials Streamline Antibacterial Improve ethics review process via use of Single IRB Organize DMCs to ensure patients safety Perform higher quality Novel Endpoints Endpoints and running trials using Mobile Technologies Overcome Decentralized Clinical Trials hurdles Engaging Sites and Patients when incorporating mobile technologies Single IRB Mobile Technologies Antibacterial Pediatric DMCs Decentralized Clinical Trials Antibacterial Pediatric Pediatric and HABP/VABP Studies HABP/VABP Studies Decentralized Clinical Trials HABP/VABP Studies Engaging Sites and Patients Informed Consent Informed Consent process Develop a better IND Safety Reporting system IND Safety Reporting IND Safety Reporting
THANK YOU. www.ctti-clinicaltrials.org
