State of Clinical Trials Annual Report

CTTI’s Tools for Improving Clinical Trial Quality & Efficiency

Posted on by Lorri Bingham

In our pursuit to enhance the implementation of CTTI’s recommendations, we’ve created a new webpage on our site that we’d like to share with you. This page features CTTI’s three most commonly used tools:

  1. The Considerations Document for a Single IRB of Record: Developed by CTTI’s Central IRB Project, this tool supports communication and contractual relationships between institutions and a central IRB to address blurred distinctions between responsibilities for ethics review and other institutional obligations. Primary users for this tool include sponsors, academic institutions, investigators, IRBs that act as a single IRB of record.
  2. The Quality by Design Principles Document: Developed by CTTI’s QbD Project, this tool helps those working in trials to promote proactive, cross-functional discussions and critical thinking at the time of trial development about what is critical to quality for a specific trial, and about the events that might impede or facilitate achieving quality. Primary users for this tool include anyone interested in designing and conducting clinical trials.
  3. The AACT Database: Developed by CTTI’s State of Clinical Trials Project, this tool makes the acquisition and analysis of the aggregate data from ClinicalTrials.gov more user-friendly. Primary users for this tool include researchers interested in analyzing data from clinical trials.

The Tools Page can be accessed on the CTTI site under Briefing Room > Tools. We hope that you find this resource valuable and share with your colleagues in the clinical trials enterprise.

ClinicalTrials.gov Registry Enables Review of Peripheral Vascular Disease Clinical Trials Portfolio

Posted on by Lorri Bingham

Peripheral Vascular Disease (PVD) poses a growing public health concern, particularly for the aging American population. While a high prevalence of vascular disease exists, and therapeutic advances have been made in this area, a systematic overview of the clinical trials portfolio for PVD has not been done, until recently.

A new Circulation publication, titled Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database, utilized the CTTI-created AACT Database, a searchable relational database of content from ClinicalTrials.gov. The AACT Database allowed researchers to analyze interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970).

The author’s conclude,

PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD.*

To view the article online, CLICK HERE.

 

*Source: Sumeet Subherwal, Manesh R. Patel, Karen Chiswell, Beth A. Tidemann-Miller, W. Schuyler Jones, Michael S. Conte, Christopher J. White, Deepak L. Bhatt, John R. Laird, William R. Hiatt, Asba Tasneem, and Robert M. Califf, “Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database,” Circulation, (Sept 19 2014).

Updated AACT Database Now Available on the CTTI Website

Posted on by Lorri Bingham

In an effort to characterize the U.S. clinical trials enterprise, CTTI’s State of Clinical Trials Project set out to facilitate the analyses of data in ClinicalTrials.gov, a registry of human clinical research studies hosted by the U.S. National Institutes of Health (NIH) in collaboration with the FDA. The result of this project was the Aggregate Analysis of ClincalTrials.gov (AACT) Database, 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 2014. To assist users with interpretation of the data, a high level dictionary and a points to consider document are also located on the CTTI website. Previous versions of AACT are available as well.