Study Operations

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

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)

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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 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.

CTTI Presents Recommendations for Strengthening the Investigator Site Community

CTTI Project: Investigator Community

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Webinar Presenters:

Presenters:

  • Christine Pierre (Society for Clinical Research Sites)
  • Matthew Roe (Duke Clinical Research Institute)
Panel members sharing their perspectives on these recommendations include:
  • David Ciavarella (C.R. Bard)
  • Robin Douglas (QuintilesIMS)
  • Terri Hinkley (Academy of Medical-Surgical Nurses)
  • Kaitlin Malone (Amgen)

Webinar Objective:

Attendees will learn how:
  • Workload, reporting burdens, time allocation challenges, and financial issues contribute to high rates of investigator turnover;
  • Investigators and study staff can benefit from improvements to research infrastructure and training and educational opportunities;
  • All stakeholders can contribute to optimizing trial conduct and to developing more efficient and transparent approaches to budgeting and contracting; and
  • Investigators can connect with opportunities to remain engaged in clinical research.

*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.

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.