CTTI News

New NIH Policy Aligns With CTTI’s Work to Increase Adoption of Central IRBs

Posted on by Lorri Bingham

The NIH has issued a final policy requiring the use of a single institutional review board (IRB) for multi-center NIH-funded clinical trials. The policy will take effect May 25, 2017.

Since 2010, CTTI has been working to address barriers to the adoption of central IRBs for multi-center clinical trials through its Central IRB and subsequent Central IRB Advancement projects. The draft NIH policy released in 2014 referenced CTTI’s recommendations, and the final policy reflects CTTI’s shared goal to increase the efficiency of clinical trials through the use of central IRBs.

With the NIH mandate now finalized, CTTI’s tools are available to help with implementation. These include the following:

  • a template IRB authorization agreement
  • an evaluation checklist with considerations for 1) assessing an institution’s readiness for central IRB adoption, 2) selecting a central IRB, and 3) deciding when a central IRB should work with a specific institution
  • a considerations document to address the often blurred distinctions between responsibilities for ethics review and other institutional obligations

According to the new policy, “while the NIH anticipates that there will be challenges associated with implementation, we expect these to be short-lived. Once the transition to the new way of operating is made, the benefits of widespread use of [single IRBs] will outweigh any costs and, ultimately, reduce burdens to the research process.”

CTTI applauds this important progress for the clinical trials enterprise.

 

Updated AACT Database Now Available & Ripe for Mining

Posted on by Lorri Bingham

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents.

CTTI’s State of Clinical Trials Project updates the Aggregate Analysis of ClincalTrials.gov (AACT) database twice annually. AACT is a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since its initial release, the AACT database has been used to answer many questions regarding the landscape of clinical trials.

This latest dataset reflects data downloaded from ClinicalTrials.gov on March 27, 2016. To assist users with the interpretation of the data, a comprehensive data dictionary and points to consider document are also available on the CTTI website. Previous versions of AACT are posted as well.

Recording Now Available: Webinar on IND Safety Reporting

Posted on by Lorri Bingham

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?

We invite you to view the recording from CTTI’s webinar, which explored challenging safety reporting scenarios using case studies. Presenters from CTTI’s IND Safety Advancement Project Team included representatives from CTTI, FDA, and industry.

To view recommendations and publications from CTTI’s IND Safety Advancement Project, CLICK HERE.

 

CTTI Program to Increase Adoption of Mobile Clinical Trials

Posted on by Lorri Bingham

MCT ProgramCTTI is excited to introduce its Mobile Clinical Trials (MCT) Program, which will identify and address challenges to the use of mobile technologies to facilitate clinical trials for regulatory submissions. These technologies have the potential to increase the quality and efficiency of clinical trials by allowing remote participation and monitoring, creating opportunities to develop novel endpoints, and streamlining data collection.

The integration of mobile technologies into clinical trials is in the early phases. Through the MCT Program, CTTI will help create a pathway to drive this promising transformation.

CTTI’s MCT Program includes four projects addressing specific challenges. Within each of these areas, CTTI’s multi-stakeholder teams have begun gathering evidence to develop tools and best practices that can be deployed throughout the clinical trials enterprise to promote widespread integration of mobile technologies.

 

Learn more about the CTTI MCT projects:

  1. Legal and Regulatory Issues
  2. Novel Endpoints
  3. Stakeholder Perceptions
  4. Use of Mobile Devices

CTTI will present on this new initiative at the Mobile in Clinical Trials Conference on Monday, September 19, 2016.

Recording Now Available: Webinar on Best Practices for DMCs From CTTI’s Latest Recommendations

Posted on by Lorri Bingham

On June 16, 2016, CTTI hosted a webinar on its new recommendations on best practices for the use of Data Monitoring Committees (DMCs). This webinar provided an opportunity to learn about ways to enhance the functioning of DMCs through member training, clear roles and responsibilities, charter development, communication practices, and more. The recommendations resulted from CTTI’s DMCs Project.

We encourage you to share this recording with your colleagues in the clinical trials enterprise.

 

Upcoming Webinar: Quality by Design for Clinical Trials

Posted on by Lorri Bingham

On August 10, CTTI will present Clinical Trial Quality by Design: Factors Critical to Quality, a joint webinar with the Medical Device Innovation Consortium (MDIC). The presentation will feature strategies for designing quality, efficient clinical trials from CTTI’s Quality by Design (QbD) Project and MDIC’s Clinical Trial Design Working Group. MDIC was able to build upon CTTI’s QbD recommendations and address special considerations for the design of medical device clinical trials. This work demonstrates a strong synergy between two multi-stakeholder public-private partnerships dedicated to improving clinical trials.

We invite you to join this free, public webinar to learn more about quality design for clinical trials, including medical device trials.

CLICK HERE to register.

Topic: Clinical Trial Quality by Design: Factors Critical to Quality

Date & Time: Wednesday, August 10, 2016 at 1 p.m. ET

Speakers:

  • Susan Alpert, MDIC Clinical Trial Design Working Group Chair
  • Ann Meeker-O’Connell, CTTI QbD Project Team

Upcoming Webinar: Global Expert Panel on Antibacterial Drug Development

Posted on by Lorri Bingham

CTTI invites you to participate in a free, public webinar to learn about collaborative and innovative approaches to address the international public health crisis of antibacterial resistance. A panel of preeminent thought leaders will present these efforts, which appear in a recently published peer-reviewed supplement in the journal Clinical Infectious Diseases (CID).

The webinar will include the presentation of two new sets of CTTI recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

This work is part of CTTI’s Antibacterial Drug Development (ABDD) Program, which includes a portfolio of projects tackling specific issues intended to improve clinical trials evaluating potential new antibacterial drugs.

We encourage you to share this invitation with others who may be interested in learning more about CTTI’s ABDD Program and the HABP/VABP Recommendations.

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

Date & Time: Wednesday, August 24, 2016, from 12:00 p.m. – 1:00 p.m. EDT (New York, GMT-04:00)

Speakers:

  • 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 Login: CLICK HERE to enter the meeting.

Meeting Number: 730 531 918

Meeting Password: ctti

After you connect to the website, please follow step-by-step instructions for connecting to the audio.

 

If you prefer to connect to audio only, you can join by phone at:

1-855-244-8681 Call-in toll-free number (US/Canada)  

1-650-479-3207 Call-in toll number (US/Canada)

Clinical Trials Transformation Initiative Releases Recommendations to Enhance the Feasibility of Developing New Antibacterial Drugs

Posted on by Lorri Bingham

Today, CTTI released two new sets of recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). This work is part of CTTI’s antibacterial drug development program, which includes a suite of projects tackling specific issues to improve clinical trials and bolster the pipeline for new antibacterial drugs.

CTTI’s new recommendations outline innovative approaches to designing clinical trials for HABP/VABP, including early enrollment strategies and the streamlined collection of safety data. CTTI convened multi-stakeholder teams to analyze the challenges associated with HABP/VABP trials and develop the proposed solutions. The feasibility of these new approaches will be tested in an upcoming pilot study, the findings of which are expected to help drive the adoption of streamlined practices for antibacterial drug development across the clinical trial enterprise.

“The CTTI project teams’ work is the type of science that can benefit the overall field of antibacterial drug development by advancing the science of clinical trials for hospital-acquired and ventilator acquired pneumonia,” said Edward M. Cox, M.D., M.P.H., Director of the Office of Antimicrobial Products from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. “We look forward to continued progress of the CTTI effort and the results from additional studies that will evaluate proposed solutions to these challenges.”

CTTI’s latest recommendations appear as part of a peer-reviewed supplement in the journal Clinical Infectious Diseases that features collaborative and innovative approaches by CTTI and others to address this pressing public health concern and speed new treatments to patients.

“This supplement from Clinical Infectious Diseases is really impressive and broad, highlighting many of the problems within antimicrobial resistance, from how to improve the development of new drugs, to engaging with the private sector. I am delighted to see such a prestigious scientific journal engage with this issue in a holistic approach looking at policy as well as scientific actions that need to be taken” said Jim O’Neill, Chair of the AMR Review.

Antibacterial resistance is an international public health crisis, and new treatment options are urgently needed. HABP/VABP occurs in seriously ill patients and is associated with high rates of antibiotic resistance and mortality. Multiple comorbidities, the rapid time course of acute illness, and other factors make conducting clinical trials in this population especially complex. “As someone whose susceptibility to multiple infections and Pneumonias has plagued me for six decades, these recommendations signal a transformational breakthrough,” said Stephen Mikita, patient advocate.

On August 24, CTTI will host a public webinar on this topic: Antibacterial Drug Development in a Time of Great Need: Global Expert Panel.

Registry-Based Clinical Trials: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

On March 30, 2016, CTTI’s Registry Trials Project held a multi-stakeholder expert meeting to accomplish the following:

  • Identify essential elements of registries needed to successfully embed and conduct registry-based clinical trials
  • Present findings from the project’s literature review and expert interviews
  • Receive feedback on potential benefits of and existing barriers to the use of registries in clinical trials
  • Reach consensus on best practices to increase adoption of clinical trials within registries

The meeting included more than 40 participants from academia, government agencies, industry, and patient representatives. A key takeaway was that a role exists for registries in creating a sustainable infrastructure to conduct regulatory trials, including early development, pre-market, and post-approval investigations. Suggestions were generated around considerations including data quality, regulatory issues, governance, and registry design. Input from the meeting, along with evidence gathered through the CTTI project, will be used to develop recommendations and tools to increase the value, acceptance, and success of registry-based clinical trials.

CLICK HERE to access the meeting summary, slides, agenda, and other materials.

CTTI’s New Website Features Content to Improve Clinical Trials

Posted on by Lorri Bingham

In furtherance of our quest to drive adoption of practices that will increase the quality and efficiency of clinical trials, CTTI has launched a new website that provides easy access to recommendations and tools that can lead to better clinical trials.

What’s new?

  • CONTENT NOW ORGANIZED BY TOPIC: The new website packages CTTI’s robust portfolio of work into intuitive, easy-to-navigate topics, such as central IRBs and recruitment.. Within each topic, the new layout gives prominence to critical content, including latest news and most used resources.
  • OPTIMIZED, RESPONSIVE LAYOUT: The updated design features a responsive layout, which will optimize the visitor’s experience across devices and browsers.
  • NEW URLs: New URLs will exist for the project and program pages, but don’t worry! We are setting up re-directs to make this transition as seamless as possible for you. This means that the old URLs will still work, but cleaner, more direct URLs will exist for content related to projects and programs.

If you are having issues locating content, you can:

  • Try the search bar, located in the top right corner of our site
  • Email our communications specialist, Noel Benedetti (noel.benedetti@duke.edu)

We welcome your feedback on the new site. If you have any suggestions for improvement, please send your thoughts to Noel. Thank you for your patience and input as we continue to improve your access to resources that help drive change in the clinical trials enterprise.