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CTTI to Host Free Public Webinar on the State of U.S. COVID-19 Treatment Clinical Trials Featuring Robert Califf, Harlan Krumholz, and Deborah Zarin
CTTI will host a free public webinar on the state of U.S. COVID-19 treatment clinical trials on Thurs., Apr. 15 at noon EST.
The U.S. has recently marked the one year anniversary of the official declaration of the COVID-19 pandemic by the World Health Organization. The pandemic thrust clinical research into the limelight like never before and – while daunting and challenging – the scientific community answered its collective call-to-duty with impressive vigor and determination. But our work continues and this anniversary provides an important opportunity for reflection, discussion and evaluation.
Many have pointed to a large number of initiated clinical trials as evidence of successful research in response to the global health crisis. However, the true measure of success should be in actionable and reliable research results that are available to inform clinical, policy and research decisions related to the diagnosis, treatment, and prevention of COVID-19 and its variants.
In this webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI will present findings from an analysis of data downloaded from the database for the Aggregate Analysis of ClinicalTrials.gov (AACT) on the state of U.S. COVID-19 studies. The presentation will include an overview of the U.S. COVID-19 clinical trials landscape, the availability of results, and changes in the portfolio as time has progressed. The presenters, including Robert Califf, Verily and Google Health; Harlan Krumholz, Yale School of Medicine; and Deborah Zarin, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, will discuss how the findings from the COVID-19 analysis can be applied to improvements needed across the clinical trials enterprise.
Upgraded AACT Database Offers Improved Functionality for Analyzing ClinicalTrials.gov Data
CTTI has launched an upgraded version of its Aggregate Analysis of ClinicalTrials.gov (AACT) database, which provides an analyzable dataset of all study information (including results) contained in ClinicalTrials.gov. These data can be used to characterize the clinical trials landscape and evaluate trends over time. CTTI gathered user feedback to design enhancements to the tool that would improve the timeliness of data, increase functionality, and make it accessible to a broader group of users.
For years, AACT has been used to uncover insights about the state of clinical trials. The datasets have been downloaded over 17,000 times and resulted in more than 20 publications. With these improvements, AACT will continue to be a valuable resource for assessing the clinical trial enterprise. For example, with the new NIH policy and the Final Rule for FDAAA 801 in effect for clinical trial results reporting, there is an opportunity for more organizations to use this timely and easily accessible data to monitor their compliance.
Previously updated twice per year, the database now resides in the cloud and is refreshed nightly with data from ClinicalTrials.gov. Historical AACT datasets also remain available for comparison. Researchers can query the database directly or download it as a static dataset. The new version of AACT is based on open-source technologies and requires no proprietary software.
Learn more about CTTI’s State of Clinical Trials Project.
New Publication: CTTI Presents a Systematic Review of Respiratory Tract Infection Trials Available on ClinicalTrials.gov
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.
Analyzed from data on ClinicalTrials.gov, Figure 2 displays the declining financial support from industry for RTI trials.
To read the publication, click here.