The DIA’s 51st Annual Meeting earlier this month was a great success. In addition to presenting preliminary findings from several CTTI projects, we also unveiled the official recommendations and associated Toolkit from our Quality by Design (QbD) Project. We’d like to thank all of our colleagues who came together for a week of engaged discussion and learning.

We are now happy to share the materials from CTTI’s presentations. We hope you find them useful in your efforts to improve the quality and efficiency of clinical trials.

DIA SESSION: CLINICAL QUALITY BY DESIGN: FROM THEORY TO PRACTICE

• Clinical Quality-by-Design (QbD): Principles to Practice by Coleen Glessner, Pfizer, Inc.
• Clinical Quality By Design: FDA Point of View by Jean Mulinde, CDER, FDA
• CLICK HERE for more information on CTTI’s Quality by Design Project.

DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS

• Introduction to the CTTI Data Monitoring Committees Project by Karim Calis, CDER/FDA and NICHD/NIH
• The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings and Next Steps by Susan Ellenberg, University of Pennsylvania
• CTTI DMC Project Survey and Focus Group Findings: Communication Practices by Ray Bain, Merck Research Laboratories
• DMC Qualification, Composition and Training by Jane Perlmutter, Patient Advocate
• CLICK HERE for more information on CTTI’s Data Monitoring Committee Project.

DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE

• The Clinical Trials Transformation Initiative IND Safety Advancement Project: Findings and Next Steps by Michael Jones, Eli Lilly & Company
• CLICK HERE for more information on CTTI’s IND Safety Advancement Project.

DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS

• CTTI Patient Groups and Clinical Trials: Building the Value Model by Matthew Harker, CTTI
• Progress Through Partnership: Actively Engaging Patient Groups in the Clinical Research Process by Petra Kaufmann, NCATS/NIH
• CTTI Patient Groups and Clinical Trials Industry Measurements by David P. Leventhal, Pfizer, Inc.
• CLICK HERE for more information on CTTI’s Patient Groups & Clinical Trials Project.

DIA POSTER: RESULTS OF AN ONLINE SURVEY OF STAKEHOLDERS REGARDING BARRIERS AND SOLUTIONS TO CLINICAL TRIAL RECRUITMENT

• CLICK HERE to view a PDF of this poster.
• CLICK HERE for more information on CTTI’s Recruitment Project.