Electronic Healthcare Data
Public and Stakeholders Encouraged to Comment on Protocol for Innovative Clinical Trial
SENTINEL IMPACT-AFIB DRAFT PROTOCOL POSTED
The draft protocol for an innovative pragmatic clinical trial examining educational methods for improving medication utilization in patients with atrial fibrillation (AFib) has been posted on Sentinel Initiative website. This draft protocol is now available for public comment and feedback as part of process that seeks to engage all potential stakeholders in study development and implementation.
The Sentinel IMPACT-AFib study grew out of findings from a pilot program in which CTTI, through its Electronic Healthcare Data project, evaluated the feasibility of using data from FDA’s Sentinel System to conduct clinical trials. IMPACT-AFib marks the first time the Sentinel System has been used to support a randomized pragmatic clinical trial—not only by serving as a primary source for study data, but also by helping study organizers to identify potential participants.
Atrial fibrillation affects more than 5 million people in the United States. It is a serious condition in which the upper chambers of the heart beat with an irregular rhythm. More common among persons aged 65 years or older, AFib increases a person’s risk of stroke by up to five times and contributes to an estimated 130,000 deaths annually in the United States alone. Although AFib can be treated effectively with a number of different oral anticoagulant (OAC) medications, many of the people who stand to benefit from these therapies do not receive them.
Find out more about AFib and the background of the Sentinel IMPACT AFib trial by clicking here to access a CTTI webinar and slides.
Recording Now Available: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib
Would you like to learn how FDA’s Sentinel System is being used for the first time to conduct a randomized clinical trial?
A recording is now available of CTTI’s webinar discussing Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). The concept for IMPACT-AFib stemmed from a collaboration between CTTI and Sentinel (formerly Mini-Sentinel) on the Uses of Electronic Healthcare Data Project to evaluate the use of Sentinel for conducting randomized trials. Sentinel has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials.
About 5 million people in the United States have atrial fibrillation, and roughly 1 in 5 strokes are due to this condition, representing a significant health burden. While anticoagulation therapy is effective for stroke prevention in this population, only about half of these patients receive this therapy according to guidelines.
The proof-of-concept IMPACT-AFib trial will use the Sentinel System to assess the ability of an educational intervention to increase anticoagulation use in at-risk patients with atrial fibrillation. The webinar discusses considerations encountered in planning for this pragmatic trial:
- Identifying eligible patients and treatments received using a distributed database with linkage to pharmacy claims
- Conducting a pilot phase
- Engaging data partners, providers, and patients in study development
- Making decisions regarding randomization and informed consent
WE INVITE YOU TO VIEW THE RECORDING, ALONG WITH THE PRESENTATION SLIDES, TO LEARN MORE ABOUT THIS EXCITING TRIAL AND THE USE OF SENTINEL TO IMPROVE CLINICAL TRIALS.
To view recordings of other CTTI webinars, CLICK HERE.
Webinar November 17: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib
On November 17, 2016, CTTI will host a webinar to provide an update on work being done as part of the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.
Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This free webinar will discuss the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.
IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.
Date & Time: Thursday, November 17, 2016, at 12:00 p.m. EST (New York, GMT-05:00)
Presenters:
- Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
- Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University
When it’s time, click here to join the meeting.
This webinar is OPEN TO THE PUBLIC. Please share with your colleagues!
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.
The Possibilities of Conducting Randomized Clinical Trials using Electronic Data in the Mini-Sentinel Environment
On May 15th Richard Platt, MD, MS, of Harvard Pilgrim Healthcare, and Patrick Archdeacon, MD, of the FDA, spoke at a CTTI-hosted webinar titled Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment. During this teleconference, Platt and Archdeacon summarized the collaborative work of CTTI and Mini-Sentinel investigators exploring the potential for building on the Sentinel’s health-plan-based teams and data infrastructure to facilitate multi-center clinical trials. A recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database, fully describes the project and results. Their talk concluded with an explanation of the follow-up phases of this work, which will likely include convening working groups to further advance the concepts put forth in this report and collaborating with other partners.
We are pleased to share the recording of this webinar with the public, and we encourage interested parties to learn more about the Mini-Sentinel.