Projects

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

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

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:

 

Antibacterial Drug Development in a Time of Great Need: Global Expert Panel

CTTI Project: Streamlining HABP/VABP Trials

Webinar Presenters:

  • Edward Cox, MD, MPH, U.S. Food and Drug Administration
  • Vance G. Fowler Jr, MD, MHS, Duke University
  • Bruno François, MD, University Hospital of Limoges, France
  • Hasan S. Jafri, MD, MedImmune
  • John H. Powers III, MD, George Washington University School of Medicine
  • John H. Rex, MD, AstraZeneca Pharmaceuticals
  • Pamela Tenaerts, MD, MBA, Clinical Trials Transformation Initiative

Webinar Objective:

On August 24, 2016, CTTI hosted a webinar on innovative approaches to transforming antibacterial drug development as recently featured in a Clinical Infectious Diseases (CID) supplement. The presentation highlighted the important role public-private partnerships play in advancing the field of antibacterial drug development and included an inside look at CTTI’s two new sets of recommendations for streamlining HABP/VABP trials. Thought leaders from CTTI, FDA, industry, and academia spoke, reflecting on the significance of this new body of work.

We are now pleased to share the webinar recording, in which you can hear more about:

  • Use of an evidence-based approach to characterize the challenges of studying new antibacterial drugs
  • Actionable solutions to these challenges developed from collaborations between multiple stakeholders
  • Ongoing work to determine the promise and potential implications of an early enrollment strategy for HABP/VABP trials

A Viewpoint on the Current State of Clinical Trials on the Path to Transformation from Dr. Robert Califf

CTTI Project: State of Clinical Trials

PDF icon Download Slides 

Webinar Presenter:

Dr. Califf, who served as an original co-chair of CTTI and was instrumental in its creation, is a prominent cardiologist and clinical researcher whose career as a physician, teacher, researcher, and regulator spans more than three decades. Dr. Califf has provided leadership for numerous high-impact clinical trials and has been at the forefront of innovation in clinical research methods.

Webinar Information:

During this webinar, Dr. Robert Califf, former Commissioner of the US Food and Drug Administration (FDA) and the Fortin Professor of Cardiology at the Duke University School of Medicine, examined the current state of the clinical trials enterprise. Specifically, he addressed recent developments that have major implications for the clinical research enterprise in the United States, including the opportunities enabled by growing access to digital sources of data, the increasing importance of patient-reported outcomes, and the power of patient engagement in reshaping approaches to clinical research. As the recent head of FDA, Dr. Califf was directly involved in cross-agency efforts to modernize the national system for conducting clinical research by articulating a large, flexible, and widely shared approach to evidence generation (known as “EvGen”) that could leverage rapidly expanding sources of digital health data to produce high-quality, actionable information for patients and healthcare providers.

A particularly important aspect of these “EvGen” efforts hinges on effectively engaging patients and their advocates as partners in research, particularly as digital technologies and patient-reported outcomes data present new potential for the rapid and seamless acquisition of health data that is truly representative of broad and diverse populations. Ultimately, it is hoped that this new national research infrastructure will enable more rapid, representative, affordable, and generalizable clinical trials that can provide the high-quality evidence to enable a true learning health system. Many of these activities draw upon insights that were developed through pioneering investigations sponsored by CTTI, whose efforts will continue to shape national approaches to the creation and implementation medical knowledge.

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.

New CTTI Project Aims to Offer Clarity Around Implementing Flexible Clinical Trial Approaches While Maintaining Data Quality

CTTI News | October 2, 2024

Topics Included: Innovative Trials

Implementing less rigid, more flexible approaches to clinical trials can increase patient and site access to research, improve participant satisfaction, facilitate real-world data use, enroll more diverse patient populations, and enable more generalizable trial results. Ultimately, these flexible trial approaches help sponsors bring new therapies to patients faster. However, despite their numerous advantages, questions remain about how to maintain data quality when adopting these strategies. High-quality trial data must be fit-for-purpose, credible, and reliable to support regulatory decision-making without jeopardizing participant safety or the integrity of trial results.

To address these questions, CTTI has started a new project to gather diverse perspectives on the advantages and disadvantages of flexible trial approaches. This includes methods such as embedding trials in clinical practice, incorporating decentralized trial elements, and allowing for setting adjustments during trial participation. Through multi-partner roundtable discussions, in-depth interviews, and surveys, CTTI will identify critical concerns and considerations for maintaining data quality when using flexible trial approaches. CTTI will outline case examples of flexible approaches in trials, identify common themes and responses from partners around these case examples, and consider a toolbox that outlines the strengths of implementing flexible approaches and provides recommendations for how to maintain data quality when incorporating them.

Pamela Tenaerts, CTTI project team lead and representative from Medable, emphasized the potential of flexible methodologies, stating, “Embracing more flexible methodologies for data collection enables us to better represent the populations we’re looking to serve while providing a better experience for participants.”

CTTI’s work in this area will help to increase the use of flexible approaches in clinical trials, resulting in improved trial access, participant satisfaction, enrollment of diverse patient populations, and trial efficiency.

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