Ensuring Quality

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.

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

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