Webinar

Series

WebinarCTTI's Webinar Series is a monthly webcast that features esteemed speakers discussing topics related to innovation and culture within the clinical trials enterprise. Below, you will find a complete list of our webinar series:

 

  1. Patient Advocacy/Industry Partnerships to Accelerate Therapy Development
  2. Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment
  3. Update of Harvard MRCT
  4. Research Institution Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States
  5. Lung Cancer Master Protocol and I-SPY 2
  6. Sponsors' Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States
  7. Results of National Public Poll on Clinical Trials
  8. TransCelerate BioPharma Presents Risk Based Monitoring Initiative to CTTI Members

 


 


 

Patient Advocacy/Industry Partnerships to Accelerate Therapy Development

DATE: July 17, 2014 12–1:00 p.m. EST.

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 Registry

OBJECTIVE: Sharon Hesterlee and Holly Peay discuss the ways in which Parent Project Muscular Dystrophy (PPMD) has partnered with industry to accelerate therapy development for Duchenne Muscular Dystrophy.

ADDITIONAL RESOURCES:

*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.

 


 

Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment

DATE: May 15, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Richard Platt, MD, MS, of Mini-Sentinel
  • Patrick Archdeacon, MD of the FDA

OBJECTIVE: Summarize the work generated by CTTI’s Uses of Electronic Data Project and the resulting, recently released white paper, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database

*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.

 


 

Update of Harvard MRCT Programmatic Activities

DATE: March 20, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Rebecca Li, Executive Director of the Multi-Regional Clinical Trials (MRCT) Center

OBJECTIVE: Rebecca Li presented an update on MRCT programmatic activities for CTTI members.

*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.

 


 

Research Institution Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States

DATE: February 6, 2014 12–1:00 p.m. EST.

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 System

OBJECTIVE: To share experiences from two research institutions about implementation of a central IRB model for multi-center clinical trials

AGENDA:

  1. Results from a randomized, controlled trial of central versus local IRB review
  2. The institutional policy resulting from study results and a summary of conclusions that can be applied more broadly
  3. The continuing role of the institution in research compliance
  4. Examples from a research institution that serves as a central IRB and relies on commercial, academic, and federal external IRBs for multicenter clinical trials
  5. Questions and Discussion

CLICK HERE to view the presentation slides.

*This webinar includes presenters from CTTI's Advancing the Use of Central IRBs for Multicenter Clinical Trials project team.

**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.

 


 

Lung Cancer Master Protocol and I-SPY 2

DATE: January 16, 2014 12–1:00 p.m. EST.

PRESENTERS

  • Jeff Allen, PhD, Friends of Cancer Research
  • Jane Perlmutter, PhD, MBA, Gemini Group

AGENDA:

  1. Lung Cancer Master Protocol presented by Jeff Allen
  2. I-SPY 2 presented by Jane Perlmutter

*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.

 


 

Sponsors' Perspectives on Advancing the Use of Central IRBs for Multicenter Clinical Trials in the United States

DATE: November 14, 2013 12–1:00 p.m. EST.

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., Director, Office of Clinical Research, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

OBJECTIVE: To share experiences across different sponsor organizations in implementation of central IRB model for multicentered clinical trials

AGENDA:

  1. Introduction: CTTI Use of Central IRBs for Multicenter Clinical Trials Project and Recommendations
  2. Sponsors’ role in choosing to use a central IRB for multicenter clinical trials
  3. One biopharmaceutical sponsor’s approach for adapting to new paradigm for IRB review in the U.S.
  4. A federal sponsor's experience of using a single central IRB for clinical trial networks
  5. Questions and Discussion

CLICK HERE to view the presentation slides.

*This webinar includes presenters from CTTI's Advancing the Use of Central IRBs for Multicenter Clinical Trials project team.

**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.

 

 


 

Results of National Public Poll on Clinical Trials

DATE: October 17, 2013 12-1:00 p.m. EST

PRESENTER: Mary Woolley, President of Research!America

SUMMARY: A few months ago, CTTI assisted with questions to include in a national poll conducted by Research!America, the nation's largest not-for-profit, membership-supported, grassroots public education and advocacy organization. They are committed to making medical and health research a higher national priority, and Woolley's review of the survey includes trust factors for clinical trial participation, as well as attitudes towards and information sources for clinical trials.

*If you wish to share this webinar with your networks, visit the accompanying blog post. From the post, submitting this webinar to Facebook, Twitter, LinkedIn, and other social sites is just a click away. 

**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.

 


 

TransCelerate BioPharma Presents Risk Based Monitoring Initiative to CTTI Members

DATE: August 20, 2013 12-1:00 p.m. EST

PRESENTER: Craig Wozniak

SUMMARY: CTTI and TransCelerate have been in an ongoing dialogue about their respective efforts, including, for example, how work related to risk based monitoring (RBM) may be integrated. This webinar features a presentation by TransCelerate highlighting their RBM initiative.

*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.