Upcoming Webinars:
There are no webinars currently scheduled. Check back for information on future webinars.
Previous Webinars:
- CTTI’s Embedding Trials Feasibility Tool Launch February 29, 2024
CTTI Project: Embedding Clinical Trials into Clinical Practice
- Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results on ClinicalTrials.gov February 15, 2024
- Virtual Public Workshop to Enhance Clinical Study Diversity (FDORA) November 30, 2023
NOVEMBER 29 & 30, 2023
- Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (FDORA) October 19, 2023
OCTOBER 18 & 19, 2023
Virtual Public Meeting Resources:
Final Meeting Report and Summary
Download full two-day PowerPoint slide set
Speaker and Panelist Biographies
Guidances and Additional Resources
Virtual Public Meeting Recordings:
Watch Day 1:
Watch Day 2:
*ASL interpretation and Closed Captioning (CC) is available on both videos.
- Increasing Diversity in Clinical Trials Recommendations Launch May 18, 2023
CTTI Project: Increasing Diversity in Clinical Trials
- New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification January 26, 2023
Webinar Presenters:
- Mitzi Allred, Merck & Co, LLC
- Jacqueline Corrigan-Curay, U.S. Food ...
- Embedding Clinical Trials into Clinical Practice Recommendations Launch December 15, 2022
CTTI Project: Embedding Clinical Trials into Clinical Practice
Webinar Presenters:
- Sam Bozzette, NIH
- Robert M. ...
- CTTI’s Digital Health Trials Hub: Revised Recommendations and New Resources for DCTs and Novel Endpoints April 6, 2022
CTTI Project: Developing Novel Endpoints and Planning Decentralized Trials
Webinar Presenters:
- Megan Doyle, Amgen
- Jorg Goldhahn, ETH ...
- Next Steps for Obtaining Novel Endpoint Reliability & Acceptance October 5, 2021
CTTI Project: Developing Novel Endpoints
Webinar Presenters:
- Michelle Crouthamel, AbbVie
- Jennifer Goldsack, DiMe
- Lindsay Kehoe, ...
- The State of U.S. COVID-19 Treatment Clinical Trials April 15, 2021
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, ...
- Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials November 12, 2020
CTTI Project: Quality by Design
Webinar Presenters:
- Greg Pennock, EMD Serono
- David Rodin, Amici Clinical Research
- Ansalan Stewart, FDA
- Karlin Schroeder, Parkinson’s Foundation
- Steve Young, CluePoints
Webinar Resources:
- New Resources for Designing and Running Master Protocols October 13, 2020
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 ...
- Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials June 18, 2020
CTTI Project: Diversity
Webinar Presenters:
- Pamela Tenaerts (Clinical Trials Transformation Initiative)
- Christina Brennan (Northwell Health)
- Richard Knight (American Association of Kidney Patients)
- Fabian Sandoval (Emerson ...
- Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits May 20, 2020
CTTI Project: Clinical Trials Issues Related to COVID-19
Webinar Presenters:
- Pamela Tenaerts (Clinical Trials Transformation Initiative)
- Jacqueline Corrigan-Curay (FDA, CDER)
- Laura Cooke (Amgen)
- Bray ...
- Designing High-Quality COVID-19 Treatment Trials April 23, 2020
CTTI Project: Quality by Design
Webinar Presenters:
- Pamela Tenaerts (Clinical Trials Transformation Initiative)
- Janet Woodcock (FDA, CDER)
- Ed Cox (Regeneron Pharmaceuticals, Inc.)
- Martin Landray ...
- Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic March 31, 2020
CTTI Project: Clinical Trials Issues Related to COVID-19
Webinar Presenters:
- David Borasky (WIRB-Copernicus Group)
- Sara Calvert (Clinical Trials Transformation Initiative)
- M. Khair ElZarrad ...
- Findings & Reflections from CTTI’s ICH E6 Renovation Work March 19, 2020
CTTI Project: Informing ICH E6 Renovation
Webinar Presenters:
- Amy Corneli (Clinical Trials Transformation Initiative)
- Pamela Gonzalez (Department of Veterans Affairs)
- Dagmar Gortz (Johnson ...
- Embracing the Value of Patient Engagement February 27, 2020
Webinar Presenters:
- Joseph DiMasi (Tufts Center for the Study of Drug Development)
- Jaye Bea Smalley (formerly of Celgene)
- Single IRB (sIRB) Adoption & Evaluation January 16, 2020
Webinar Presenters:
- Cynthia Hahn (Integrated Research Strategy)
- Stephen Rosenfeld (SACHRP)
- Heather Pierce (AAMC)
- Patient Engagement in Action: Insights from Patients & the FDA November 21, 2019
Webinar Presenters:
- Andrea Furia-Helms (OC/FDA)
- Michelle Tarver (CDRH/FDA)
- Robyn Bent (CDER/FDA)
- Diane Maloney (CBER/FDA)
- Theresa Strong (Foundation for Prader-Willi Research)
Webinar Resources:
- Using RWD to Plan Eligibility Criteria and Improve Recruitment in Clinical Trials October 17, 2019
Webinar Presenters:
- Sudha Raman, Duke University
- Jack Sheehan, Janssen Scientific Affairs
- Quality by Design – From Concept to Implementation and Beyond April 18, 2019
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
- Optimizing Mobile Clinical Trials by Engaging Patients and Sites February 21, 2019
Webinar Presenters:
- Leanne Madre (CTTI)
- Cindy Geoghegan (Individual Patient Representative)
- Virginia Nido (Genentech-a member of the Roche Group)
Webinar Resources:
- New Clarity to Improve Qualification of Investigators November 18, 2018
CTTI Project: Investigator Qualification
Webinar Presenters:
- Jimmy Bechtel (Society for Clinical Research Sites)
- Sabrina Comic-Savic (The Medicines Company)
- Kate Haratonik (Genentech-a member of ...
- A New Path Forward for Using Decentralized Clinical Trials October 18, 2018
CTTI Project: Supporting Decentralized Trial Approaches
Webinar Presenters:
- Jeffry Florian (FDA/CDER)
- Penny Randall (IQVIA)
- Pamela Tenaerts (CTTI)
- Medical Device Innovation Consortium May 17, 2018
Webinar Presenters:
- Stephanie Christopher (Medical Device Innovation Consortium)
- Dan Schwartz (Medical Device Innovation Consortium)
- CTTI Presents Recommendations for Strengthening the Investigator Site Community October 19, 2017
Webinar Presenters:
Presenters:
- Christine Pierre (Society for Clinical Research Sites)
- Matthew Roe (Duke Clinical Research Institute)
Panel members sharing their perspectives on these recommendations include:
- David Ciavarella (C.R. Bard)
- Robin Douglas (QuintilesIMS)
- Terri ...
- How Improved Pregnancy Testing Planning Can Lead to Safer, More Efficient Clinical Trials August 24, 2017
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 ...
- Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials June 27, 2017
Webinar Presenters:
- Martin Landray, PhD, FRCP, University of Oxford
- Marc Walton, Johnson and Johnson
- Leonard Sacks, FDA
- Lauren Bataille, The Michael J Fox Foundation
- Wendy Snyder, Amgen
- Rob Wilson, ActiGraph
Webinar Objective:
Mobile technologies ...
- CTTI Presents Recommendations from the Registry Trials Project May 18, 2017
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, ...
- Preliminary Evidence from Sponsors & Investigators Using Mobile Devices April 17, 2017
Webinar Presenters:
Project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips)
Webinar Objective:
In this webinar, project leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry ...
- A Viewpoint on the Current State of Clinical Trials on the Path to Transformation from Dr. Robert Califf March 14, 2017
Webinar Presenter:
Dr. Califf, who served as an original co-chair of CTTI and was instrumental in its creation, is a prominent cardiologist and clinical researcher whose career ...
- CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trial Project February 16, 2017
CTTI has released new recommendations to improve the quality and efficiency of research studies used to develop antibacterial drugs for children. In addition, many of the suggested ...
- Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database November 17, 2016
Webinar Presenters:
- Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
- Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University
Webinar Objective:
This webinar provides ...
- Antibacterial Drug Development in a Time of Great Need: Global Expert Panel August 24, 2016
Webinar Presenters:
- Edward Cox, MD, MPH, U.S. Food and Drug Administration
- Vance G. Fowler Jr, MD, MHS, Duke University
- Bruno François, MD, University Hospital of Limoges, France
- Hasan S. Jafri, ...
- CTTI Recommendations on Best Practices for the Use of DMCs June 16, 2016
Webinar Presenters:
- Karim Anton Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- Jane Perlmutter, PhD, Patient Advocate
- Dave DeMets, PhD, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin ...
- CTTI Presents Recommendations for Recruitment: Moving Recruitment Planning Upstream to Reduce Barriers May 19, 2016
- Case Studies on Expedited IND Safety Reporting April 21, 2016
Webinar Presenters:
- Annemarie Forrest, Senior Clinical Project Manager, CTTI
- Patrick Archdeacon, Senior Clinical Advisor, Office of Medical Policy, Food and Drug Administration, Center for Drug Evaluation and Research
- Nina ...
- Presenting CTTI Recommendations: Informed Consent November 19, 2015
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 ...
- Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials October 15, 2015
Webinar Presenters
- Sharon Hesterlee (Myotonic Dystrophy Foundation)
- Patricia Cornet (Bristol-Myers Squibb)
- Scott Weir (KUMC)
Webinar Objective
Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective ...
- Medical Device Innovation Consortium’s (MDIC) Patient Centered Benefit-Risk (PCBR) Framework August 20, 2015
Webinar Presenters:
- Ross Jaffe, Managing Director, Versant Ventures; Director, National Venture Capital Association; Board Champion, MDIC
- Kathryn O’Callaghan, Associate Center Director for Science & Strategic Partnerships, FDA CDRH
Webinar Objective
This webinar ...
- Quality by Design Project: Recommendations and Toolkit July 16, 2015
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 & ...
- MIT Collaborative Initiatives’ Clinical Trials Systems Project: An Introduction May 21, 2015
Webinar Objective
Tenley Albright, Tak Igusa, and Enrique Martinez present on The MIT Collaborative Initiatives’ Clinical Trials Systems Project.
- Translating Quality by Design Principles into Practice, Part 3 April 15, 2015
Webinar Objective
This webinar is the third in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about ...
- Translating Quality by Design Principles into Practice, Part 2 January 14, 2015
Webinar Objective
This webinar is the second in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about ...
- Translating Quality by Design Principles into Practice, Part 1 October 16, 2014
Webinar Objective
This webinar is the first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. Click here for more information about ...
- Patient Advocacy/Industry Partnerships to Accelerate Therapy Development July 17, 2014
Webinar Presenters:
- Sharon Hesterlee, Ph.D., Vice President Research, Parent Project Muscular Dystrophy
- Holly Peay, MS CGC, Vice President, Education and Outreach, Parent Project Muscular Dystrophy, and Director, DuchenneConnect ...
- Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment May 15, 2014
Webinar Presenters:
- Richard Platt, MD, MS, of Mini-Sentinel
- Patrick Archdeacon, MD of the FDA
Webinar Objective:
- Update of Harvard MRCT Programmatic Activities March 20, 2014
Webinar Presenters:
- Rebecca Li, Executive Director of the Multi-Regional Clinical Trials (MRCT) Center
Webinar Objective:
Rebecca Li presented an update on MRCT programmatic activities for CTTI members.
- Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States February 6, 2014
Webinar Presenters
- Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
- Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health ...
- Research Institution Perspectives on Advancing the Use of Central IRBs for Multi-center Clinical Trials in the United States February 6, 2014
Download Slides (842.5 KB)
Webinar Presenters:
- Daniel Nelson, Director, Office of Human Research Ethics, University of North Carolina at Chapel Hill
- Cynthia Hahn, VP, ...
- Lung Cancer Master Protocol and I-SPY 2 January 16, 2014
Webinar Presenters:
- Jeff Allen, PhD, Friends of Cancer Research
- Jane Perlmutter, PhD, MBA, Gemini Group
Webinar Agenda
- Lung Cancer Master Protocol presented by Jeff Allen
- I-SPY 2 presented by Jane Perlmutter
Webinar Presenters:
- Cynthia Hahn, VP, Clinical Research and Regulatory Affairs, North Shore-LIJ Health System
- Soo Bang, Sr. Director, Business Development & Global Alliances, Celgene Corporation
- Petra Kaufmann, M.D., M.Sc., ...
- Results of National Public Poll on Clinical Trials October 17, 2013
Webinar Presenters:
- Mary Woolley, President of Research!America
Webinar Agenda
A few months ago, CTTI assisted with questions to include in a national poll conducted by Research!America, the ...
- TransCelerate BioPharma Presents Risk Based Monitoring Initiative to CTTI Members August 20, 2013