Novel Endpoints

New Resources for Designing and Running Master Protocols

CTTI Project: Master Protocol Studies

 

Webinar Presenters:

  • Abby Bronson, Edgewise Therapeutics
  • Marianne Chase, Massachusetts General Hospital
  • Daniel Millar, Janssen R&D
  • Nick Richardson, FDA, CDER

Webinar Resources:

PDF iconDownload Slides

CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trial Project

CTTI Project: ABDD Peds Trials

CTTI has released new recommendations to improve the quality and efficiency of research studies used to develop antibacterial drugs for children. In addition, many of the suggested strategies and practices could be applied to streamline clinical trials of other types of drugs and medical devices for children.

These recommendations resulted from a collaborative effort among research sponsors, parents, investigators, clinicians, and regulators from the US and the EMA (European Medicines Agency), who provided practical suggestions for the timing of pediatric trials, streamlining trial design, facilitating informed consent, and fostering global and community partnerships to conduct trials that can improve children’s health.

Click here to view the press release that accompanied the release of these recommendations.

 

PDF icon Download Slides (653.36 KB)

Webinar Presenters:

  • Sumathi Nambiar, Food and Drug Administration
  • John Bradley, University of California, San Diego
  • Gary Noel, Johnson and Johnson Pharmaceutical Research and Development

Webinar Objective:

The webinar included practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials.

Learn these tips and more for making your trials more successful:

  • Importance of engaging with regulators early and throughout medical product development
  • Methods of streamlining trial design to decrease burden on sites and families
  • Special considerations for conducting trials with neonates
  • Approaches for improving the informed consent process
  • Ways to increase engagement with healthcare providers

Although developed in the context of antibacterial drug development, many of the recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.

Webinar Resources

During the Q&A, Sumathi Nambiar referenced the FDA Workshop on Anti-Infective Drug Development in Neonates.

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 Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials

CTTI Project: Developing Novel Endpoints

PDF icon Download Slides

Webinar Presenters:

Presenters:

  • Martin Landray, PhD, FRCP, University of Oxford
  • Marc Walton, Johnson and Johnson

Panelists:

  • Leonard Sacks, FDA
  • Lauren Bataille, The Michael J Fox Foundation
  • Wendy Snyder, Amgen
  • Rob Wilson, ActiGraph

Webinar Objective:

New CTTI Recommendations and Tools Equip Stakeholders to Integrate Mobile Technology into Clinical Trials

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. In this webinar, CTTI unveils recommendations and tools that aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

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

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

Recording Now Available: CTTI Unveils New Tool for Embedding Clinical Trials into Clinical Practice

Posted on by Hannah Faulkner

A recording of CTTI’s Feb. 29 webinar unveiling a new tool that aids in assessing the feasibility of embedding clinical trial elements into clinical practice is now available. 

The one-hour webinar included a welcome from CTTI Director of Projects Sara Calvert; a project overview from CTTI Senior Project Manager Lindsay Kehoe; a panel discussion focused on stakeholder perspectives related to the practical use of the tool; and a request for input on how to optimize the tool’s use.  

Embedding elements of clinical trials, such as patient identification, informed consent, and data acquisition, into routine care reduces duplication of trial and care activities and promotes the development of a learning health care system. This can naturally lead to better decision-making,  treatment options, and outcomes for patients.  

This tool is a part of CTTI’s Embedding Trials in Clinical Practice work, which aims to enable health care settings to participate in embedded trials and assists sponsors with their design and conduct.  

View the slide deck to learn more.