Study Design

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)

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CTTI Presents Recommendations for Recruitment: Moving Recruitment Planning Upstream to Reduce Barriers

CTTI Project: Recruitment

The slides and responses from the webinar’s Q&A session are also available for download.

Webinar Presenters:

  • Jonca Bull, MD, Director, Office of Minority Health, US Food and Drug Administration
  • Elizabeth Mahon, JD, Associate Director Global Clinical Operations – US, Janssen R&D

*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 Objectives:

This webinar reviews CTTI's Recruitment Recommendations and tools developed to help clinical trialists meet their patient recruitment goals. In this session, patient recruitment managers, program and portfolio directors, clinical trial sponsors and designers, and clinical investigators can learn more about:

  • A holistic approach that integrates strategic recruitment planning throughout the entire clinical trial process, beginning with study design and development
  • Ways to identify and engage all relevant stakeholders throughout recruitment planning to prevent downstream recruitment challenges
  • Recommendations for trial feasibility, site selection, and developing strategic recruitment communication plans
  • New tools available to aid in strategic recruitment planning

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 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

Webinar Resources:

Download PowerPoint slideset

Accelerating Evidence Generation – Resources for Implementing a QbD Approach to Clinical Trials

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:

Download Powerpoint Slideset

Resources: