Webinars

Quality by Design Project: Recommendations and Toolkit

CTTI Project: Quality by Design

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 & Epidemiological Studies Unit, University of Oxford

*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:

The Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

Presenting CTTI Recommendations: Effective Engagement with Patient Groups Around Clinical Trials

CTTI Project: Patient Group Engagement

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Webinar Presenters

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

*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

Team members from CTTI’s Patient Groups & Clinical Trials project presented the official recommendations on effective engagement with patient groups around clinical trials. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

Presenting CTTI Recommendations: Informed Consent

CTTI Project: Informed Conent

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 Human Research Protections, Director of MU Institutional Review Board, University of Missouri

*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:

Team members from CTTI’s Informed Consent Project unveiled the official recommendations resulting from this project. These recommendations propose a new model for the informed consent process that places the focus back where it should be: on the participant.

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 Recommendations on Best Practices for the Use of DMCs

CTTI Project: Data Monitoring Committees (DMCs)

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 - Madison

Webinar Objectives:

This webinar covers CTTI's recommendations on best practices for the use of Data Monitoring Committees (DMCs), intended to enhance the functioning of a DMC, beginning with training of members. Other issues addressed by CTTI include the role and responsibilities of the DMC, composition of members, development of a charter, and communication with the trial sponsor and others. CTTI's recommendations can help to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify, or terminate a trial based on the benefit-risk assessment.

Lung Cancer Master Protocol and I-SPY 2

Webinar Presenters:

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

*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 Agenda

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

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