Formats

Designing High-Quality COVID-19 Treatment Trials

CTTI Project: Quality by Design

 

Webinar Presenters:

  • Pamela Tenaerts (Clinical Trials Transformation Initiative)
  • Janet Woodcock (FDA, CDER)
  • Ed Cox (Regeneron Pharmaceuticals, Inc.)
  • Martin Landray (University of Oxford)
  • John Marshall (WHO Clinical Characterization and Management Working Group, Unity Health CA)
  • Karlin Schroeder (Parkinson's Foundation)
  • Fergus Sweeney (European Medicines Agency)
  • Ann Meeker O'Connell (Vertex Pharmaceuticals)

PDF icon Download Slides

 

 

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

Webinar Resources:

Download PowerPoint slideset

CTTI Presents Recommendations from the Registry Trials Project

CTTI Project: Registry Trials

PDF icon 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 Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

CTTI Project: Developing Novel Endpoints

PDF icon Download Slides

Webinar Presenters:

Presenters:

  • Martin Landray, PhD, FRCP, University of Oxford
  • Marc Walton, Johnson and Johnson

Panelists:

  • Leonard Sacks, FDA
  • Lauren Bataille, The Michael J Fox Foundation
  • Wendy Snyder, Amgen
  • Rob Wilson, ActiGraph

Webinar Objective:

New CTTI Recommendations and Tools Equip Stakeholders to Integrate Mobile Technology into Clinical Trials

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. In this webinar, CTTI unveils recommendations and tools that aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

Case Studies on Expedited IND Safety Reporting

CTTI Project: Safety Reporting

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 Stuccio, Head, Medical Safety Review, Global Clinical Safety & Pharmacovigilance, Merck, Inc

*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:

Are you confused about how best to comply with the FDA final rule on IND safety reporting? Would you like to hear more about how to handle common, yet challenging, safety reporting situations? Do you know someone who is interested?

This webinar is hosted by CTTI's IND Safety Advancement Project Team and is the first in a CTTI-hosted series designed to explore challenging safety reporting scenarios using case studies.