Quality

Updated AACT Database Now Available on the CTTI Website

Posted on by Lorri Bingham

CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, by creating the database for Aggregate Analysis of ClincalTrials.gov (AACT), a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in September 2015. 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.

Since CTTI released the first AACT database five years ago, it has been utilized to answer many questions regarding the landscape of clinical trials.

New Publication: CTTI Presents a Systematic Review of Respiratory Tract Infection Trials Available on ClinicalTrials.gov

Posted on by Lorri Bingham

Annals of the American Thoracic Society published Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov on September 11, 2015. CTTI, in collaboration with the FDA, analyzed data from respiratory tract infection (RTI) trials registered between 2007 and 2012 on ClinicalTrials.gov to identify gaps in antibacterial research and inform possible interventions to the public health crisis of increasing antimicrobial resistance. Of the 69,779 trials registered between 2007 and 2012, 1,377 (2%) of these were RTI trials, which were found to be more likely than other infectious-disease or non-infectious-disease trials to be funded by industry. However, stratification of RTI trials by registration year revealed that industry funding is decreasing from approximately 65% of RTIs in 2007-2008 to 46% in 2011-2012. RTI trials more frequently evaluated vaccines compared to infectious-disease trials overall. Lower respiratory tract infection (LRTI) trials were mainly focused on bacterial pathogens (78.5%) and the majority of LRTI trials registered between 2007 and 2012 were treatment-focused; however, a multivariable logistic regression analysis indicated that a treatment-focused RTI trial was associated with decreased odds of publication. Despite the increasing emergence of multidrug-resistant microbes, currently FDA-approved antimicrobials were more commonly tested in RTI trials, and the number of trials investigating novel antimicrobial agents was low. Throughout the study period, the number of LRTI trials overall and prevention-oriented LTRI trials did not increase. This was partly attributed to a decrease in industry sponsorship and funding. These findings should prompt an examination of resource allocation in infectious-diseases trials and LRTI trials in particular.

“Our study is the first to characterize the spectrum of RTI trials. This is a critically important topic, as LRTIs are the most common cause of communicable-disease-related deaths worldwide and in the United States (28% and 45%, respectively) but comprise only 3% of infectious-disease trials.”
– Ruopp, et al.

Figure 2

Analyzed from data on ClinicalTrials.gov, Figure 2 displays the declining financial support from industry for RTI trials.

 

To read the publication, click here.

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

Posted on by Hannah Faulkner

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

CTTI’s QbD Recommendations & Toolkit to be Featured in Upcoming NIH Collaboratory Grand Rounds

Posted on by Lorri Bingham

On August, 21, 2015, the recommendations and Toolkit resulting from CTTI’s Quality by Design Project will be featured in an NIH Collaboratory Grand Rounds webinar. QbD Team Leaders Ann Meeker-O’Connell of Johnson & Johnson and Mark Behm of AstraZeneca will be presenting.

“This toolkit represents a compilation of documents, guidelines, forms, and videos that will help you put Quality by Design into operation within your organization. It’s been developed by professionals from across the entire spectrum of the clinical trials endeavor.”
– Mark Behm, AstraZeneca

Webinar Details:

We encourage you to share this invitation with colleagues involved in the clinical trials enterprise.

#InnovationThroughCollaboration

Updated AACT Database Now Available on the CTTI Website

Posted on by Lorri Bingham

CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, by creating the database for Aggregate Analysis of ClincalTrials.gov (AACT), a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since the original AACT was created in 2010, we’ve continued to regularly issue updated versions of the database.

The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents. This dataset reflects data downloaded from ClinicalTrials.gov in March 2015. To assist users with interpretation of the data, high level and comprehensive data dictionaries and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.

Since CTTI released the first AACT database five years ago, it has been utilized to answer many questions regarding the landscape of clinical trials. For a list of peer-reviewed publications that have assessed the state of trials within medical specialties, CLICK HERE.

New CTTI Webinar Available Online: An Introduction to QbD Recommendations & Toolkit

Posted on by Lorri Bingham

On July 16, 2015, the Quality by Design (QbD) project team presented the QbD recommendations and an introduction to the QbD Toolkit. Released on June 15, 2015, this web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts. Whether you are first learning about QbD, want to disseminate these concepts within your organization, or are ready to implement QbD into your clinical trial, this Toolkit has resources for you.

A recording of this webinar is now available on the CTTI website.

Webinar Invitation: CTTI’s Recommendations & Toolkit for Implementing QbD in Clinical Trials

Posted on by Lorri Bingham

CTTI invites you to participate in a webinar hosted by the Quality by Design Project Team. During this webinar the project team will present the Quality by Design (QbD) recommendations and provide an introduction to the QbD Toolkit, released June 15, 2015. This web-based Toolkit provides resources for facilitating adoption and real world application of QbD concepts.

Topic: Quality by Design Project: Recommendations and Toolkit

Date: Thursday, July 16th, 2015

Time: 12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)

Presenters:

  • Ann Meeker-O’Connell, Head, Risk Management and External Engagement, Johnson & Johnson BioResearch Quality & Compliance
  • Coleen Glessner, MBA, Quality Expert
  • Martin Landray, Clinical Trials Service Unit & Epidemiological Studies Unit, University of Oxford

To join:

  • Meeting Link: Click here
  • Meeting Number: 735 985 012
  • 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)

 

To view recordings of past CTTI QbD webinars, click here.

This webinar is open to the public. We encourage you to forward this invitation to others who may be interested in learning more about the QbD project’s recommendations and Toolkit.

What is Quality by Design?
Quality by Design (QbD) is an approach that focuses effort on those “errors that matter” for the success of the clinical trial. By prospectively examining the objectives of a trial and defining factors critical to meeting these objectives, action can be taken to prevent important risks to these critical factors from negatively impacting outcomes. Understanding what data and processes underpin a successful trial is essential to subsequently identifying and managing important and likely risks to improve quality and outcomes for clinical trials. For more information about QbD, click here.

#DIA2015 Wrap-Up: CTTI Conference Materials Available Online

Posted on by Lorri Bingham

The DIA’s 51st Annual Meeting earlier this month was a great success. In addition to presenting preliminary findings from several CTTI projects, we also unveiled the official recommendations and associated Toolkit from our Quality by Design (QbD) Project. We’d like to thank all of our colleagues who came together for a week of engaged discussion and learning.

We are now happy to share the materials from CTTI’s presentations. We hope you find them useful in your efforts to improve the quality and efficiency of clinical trials.

DIA SESSION: CLINICAL QUALITY BY DESIGN: FROM THEORY TO PRACTICE

DIA SESSION: THE CLINICAL TRIALS TRANSFORMATION INITIATIVE DATA MONITORING COMMITTEE PROJECT: FINDINGS AND NEXT STEPS

 

DIA SESSION: TRANSLATING NEW KNOWLEDGE FROM REGULATORY SCIENCE INTO POSTMARKETING SAFETY PRACTICE

 

DIA SESSION: BEST PRACTICES FOR EFFECTIVE ENGAGEMENT WITH PATIENT GROUPS AROUND CLINICAL TRIALS

 

DIA POSTER: RESULTS OF AN ONLINE SURVEY OF STAKEHOLDERS REGARDING BARRIERS AND SOLUTIONS TO CLINICAL TRIAL RECRUITMENT

  • CLICK HERE to view a PDF of this poster.
  • CLICK HERE for more information on CTTI’s Recruitment Project.