CTTI Project: Quality by Design
Webinar Presenters:
- Jean Mulinde, U.S. Food & Drug Administration/CDER
- Annemarie Forrest, CTTI
- Hamid Moradi, University of California, Irvine
- Dan Cooper, University of California, Irvine
- Ann Meeker-O'Connell, IQVIA
Study Design
New Resources for Designing and Running Master Protocols
CTTI Project: Master Protocol Studies
Webinar Presenters:
- Abby Bronson, Edgewise Therapeutics
- Marianne Chase, Massachusetts General Hospital
- Daniel Millar, Janssen R&D
- Nick Richardson, FDA, CDER
Webinar Resources:
- Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success
- Master Protocol Content Development Guide
- Master Protocol Value Proposition Guide
- Statistical Simulation in Master Protocols: Components & Communications Considerations
- Master Protocol FDA Engagement Tool
- Master Protocol References & Resources
- Case Study: Using Central Labs in Master Protocols
- STAMPEDE Case Study: Using a Master Protocol Approach to Improve Outcomes in Prostate Cancer
- Master Protocol Studies: Emerging Best Practices to Drive Multi-Stakeholder Collaboration & Mobilization
- Master Protocol High Level Project Image
The State of U.S. COVID-19 Treatment Clinical Trials
CTTI Project: State of Clinical Trials
Webinar Presenters:
- Robert Califf, Verily and Google Health
- Harlan Krumholz, Yale School of Medicine
- Leanne Madre, CTTI
- Deborah Zarin, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard University
Quality by Design Project: Recommendations and Toolkit
CTTI Project: Quality by Design
Webinar Presenters:
- Ann Meeker-O'Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
- Coleen Glessner, MBA, Quality Expert
- Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford
*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.
Webinar Objective:
The Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.
Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials
CTTI Project: Patient Group Engagement
Webinar Presenters
- Sharon Hesterlee (Myotonic Dystrophy Foundation)
- Patricia Cornet (Bristol-Myers Squibb)
- Scott Weir (KUMC)
*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.
Webinar Objective
Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.
Presenting CTTI Recommendations: Informed Consent
CTTI Project: Informed Conent
Webinar Presenters:
- Jennifer Lentz, Global Informed Consent Process Owner, US CMS Coordinator, Global Clinical Operations, Eli Lilly and Company
- Michele Kennett, Assistant Vice Chancellor for Research, Director of Human Research Protections, Director of MU Institutional Review Board, University of Missouri
*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.
Webinar Objective:
Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.
CTTI Presents Recommendations from the Registry Trials Project
CTTI Project: Registry Trials
Download Slides (653.36 KB)
Webinar Presenters:
- John Laschinger, MD, Medical Officer, Center for Devices and Radiological Health, US Food and Drug Administration
- Jules Mitchel, MBA, PhD, President, Target Health Inc
Webinar Objective:
This webinar covers CTTI's recommendations on conducting clinical trials using registries. Those interested in evaluating or designing a registry for the purposes of conducting clinical trials can learn more about the project’s tools, intended for the following purposes:
- To determine if an Existing Registry is appropriate for embedding clinical trials
- To assess if an Existing Registry contains the elements needed to support a clinical trial
- To design a New Registry suitable for embedding clinical trials
Webinar Resources:
Download the CTTI Registry Trials Recommendations.
*Mentioned during Q&A: Registry of Patient Registries: patientregistry.ahrq.gov/
*CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. If you use any of the slides from this presentation, please let us know, credit CTTI, and make it clear that you are not presenting on behalf of CTTI.
Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment
CTTI Project: Electronic Healthcare Data
Webinar Presenters:
- Richard Platt, MD, MS, of Mini-Sentinel
- Patrick Archdeacon, MD of the FDA
*The views and opinions expressed in this video are those of the speaker and do not necessarily reflect the official policy or position of CTTI.
Webinar Objective:
Summarize the work generated by CTTI’s Uses of Electronic Data Project and the resulting, recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database
How Improved Pregnancy Testing Planning Can Lead to Safer, More Efficient Clinical Trials
CTTI Project: Pregnancy Testing
Webinar Presenters:
- Claire Jurkowski, MD, former medical director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb (Retired)
- Jessica Morse, MD, MPH, assistant professor, University of North Carolina School of Medicine
- Evan Myers, MD, MPH, professor, Duke University Medical Center
Webinar Objective:
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. In this webinar, CTTI unveils new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, to conduct safer, more efficient clinical trials.
Webinar Agenda:
The webinar will include:
- Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
- A new online application to help assess the balance of benefits and burdens of specific pregnancy testing plans
- Ways study coordinators can improve communication so women receive clear, comprehensive information before joining a clinical trial
- How these new recommendations promote the safe inclusion of women in clinical trials
Increasing Diversity in Clinical Trials Recommendations Launch
CTTI Project: Increasing Diversity in Clinical Trials
Webinar Presenters:
- Richardae Araojo, U.S. Food & Drug Administration (FDA)
- Ruma Bhagat, Genentech - a member of the Roche Group
- Sara Calvert, CTTI
- Luther T. Clark, Merck & Co, LLC
- Dawn Corbett, National Institutes of Health Office of Extramural Research (OER)
- Tesheia Johnson, Yale University
- Jane Williams, Syneos Health
- Glendon Zinser, Susan G. Komen