Formats

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

CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trial Project

CTTI Project: ABDD Peds Trials

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 strategies and practices could be applied to streamline clinical trials of other types of drugs and medical devices for children.

These recommendations resulted from a collaborative effort among research sponsors, parents, investigators, clinicians, and regulators from the US and the EMA (European Medicines Agency), who provided practical suggestions for the timing of pediatric trials, streamlining trial design, facilitating informed consent, and fostering global and community partnerships to conduct trials that can improve children’s health.

Click here to view the press release that accompanied the release of these recommendations.

 

PDF icon Download Slides (653.36 KB)

Webinar Presenters:

  • Sumathi Nambiar, Food and Drug Administration
  • John Bradley, University of California, San Diego
  • Gary Noel, Johnson and Johnson Pharmaceutical Research and Development

Webinar Objective:

The webinar included practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials.

Learn these tips and more for making your trials more successful:

  • Importance of engaging with regulators early and throughout medical product development
  • Methods of streamlining trial design to decrease burden on sites and families
  • Special considerations for conducting trials with neonates
  • Approaches for improving the informed consent process
  • Ways to increase engagement with healthcare providers

Although developed in the context of antibacterial drug development, many of the recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.

Webinar Resources

During the Q&A, Sumathi Nambiar referenced the FDA Workshop on Anti-Infective Drug Development in Neonates.

Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic

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 (Food and Drug Administration/CDER)
  • Cindy Geoghegan (Individual Patient Representative/Caregiver)
  • Colleen Rouse (Cleveland Clinic)
  • Pamela Tenaerts (Clinical Trials Transformation Initiative)

PDF icon Download Slides

 

 

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.