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Webinar November 17: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib

Posted on by Lorri Bingham

CTTI Webinar InvitationOn 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.

Topic: Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database

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.

Add to your calendar!

This webinar is OPEN TO THE PUBLIC. Please share with your colleagues!

 

 

Improving Pediatric Trials in Antibacterial Drug Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

View Expert Meeting MaterialsOn April 5, 2016, CTTI’s Pediatric Antibiotic Trials Project hosted a multi-stakeholder expert meeting to develop consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs. Findings from the project’s surveys and interviews were presented, and stakeholders from across the clinical trial enterprise provided input on draft considerations for improving pediatric antibacterial drug trials.

Areas of focus at the expert meeting included challenges in designing and conducting pediatric trials (including neonatal studies), pediatric labeling, and informed consent. Potential strategies discussed to address these challenges included developing pan-global networks to conduct pediatric trials using master protocols, achieving alignment between global regulatory agencies, improving awareness of opportunities for industry to communicate with the FDA when designing Pediatric Study Plans, and improving communication in the consent process.

We now invite you to view the materials from this meeting. The multi-stakeholder feedback from the meeting, along with evidence gathered through the CTTI project, is being used to inform the development of recommendations to help achieve higher quality, more efficient pediatric trials for antibacterial drugs. CTTI’s official recommendations are expected to be released in 2017.

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

This project is part of CTTI’s Antibacterial Drug Development Program.

CTTI Welcomes Its Newest Members, Alnylam and ASCO

Posted on by Lorri Bingham

CTTI 2016 Membership

CTTI is pleased to welcome its newest members, Alnylam Pharmaceuticals and the American Society of Clinical Oncology (ASCO).

Alnylam Pharmaceuticals is a pharmaceutical company focusing on the development of new therapeutics that use the RNA interference process to silence disease-causing genes. Their representative joining CTTI’s Steering Committee is Pushkal Garg, Senior Vice President, Clinical Development.

ASCO is the leading professional organization for physicians and oncology professionals caring for people with cancer. Their representative joining CTTI’s Steering Committee is Patricia Hurley, Associate Director, Research and Analysis, Policy and Advocacy Department.

Alnylam and ASCO join over 80 other diverse member organizations that are collaborating with CTTI to develop solutions with real-world impact. CTTI actively engages all stakeholders equally to improve the quality and efficiency of the clinical trials enterprise. Learn more about our diverse membership.

 

*These numbers reflect organizations on CTTI’s Steering Committee. In addition, our membership includes 3 individual patient/caregiver representatives.

CTTI Insights for Research Sites Featured at Upcoming SCRS Summit

Posted on by Lorri Bingham

SCRS Global Site Solutions SummitCTTI’s work will be featured in two presentations at the upcoming Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on October 13-16, a conference aimed at fostering collaboration between industry and sites in clinical research.

CTTI Executive Director Pamela Tenaerts will be sharing insights on initiatives to assist sites as key stakeholders in studies and to improve overall collaboration in clinical research. Tenaerts will reinforce CTTI’s commitment to help sites be successful.

SCRS President Christine Pierre will present CTTI’s research on investigator turnover and its impact on-site resources and overall trial performance. Investigator turnover is a major inhibitor of site efficiency in trials, and Pierre will share ideas for better supporting sites in order to increase PI retention.

CTTI is proud to participate in this conference aimed at building strong partnerships between stakeholders.

 

SCRS 2016 Global Site Solutions Summit
Conference Location: Boca Raton, Florida

Presentation Topic: Investigator Turnover
Speaker: Christine Pierre
Date & Time: October 14, 2016, at 4:10 p.m. ET

Presentation Topic: Sites Matter: Industry Collaboration
Speaker: Pamela Tenaerts
Date & Time: October 14, 2016, at 5:30 p.m. ET

 

 

Webinar Recording Available: Global Expert Panel on Antibacterial Drug Development

CTTI News | September 15, 2016

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals

On August 24, 2016, CTTI hosted a webinar on innovative approaches to transforming antibacterial drug development as recently featured in a Clinical Infectious Diseases (CID) supplement. The presentation highlighted the important role public-private partnerships play in advancing the field of antibacterial drug development and included an inside look at CTTI’s two new sets of recommendations for streamlining HABP/VABP trials. Thought leaders from CTTI, FDA, industry, and academia spoke, reflecting on the significance of this new body of work.

We are now pleased to share the webinar recording, in which you can hear more about:

  • Use of an evidence-based approach to characterize the challenges of studying new antibacterial drugs
  • Actionable solutions to these challenges developed from collaborations between multiple stakeholders
  • Ongoing work to determine the promise and potential implications of an early enrollment strategy for HABP/VABP trials

Learn more about CTTI’s Streamlining HABP/VABP Trials Project and Antibacterial Drug Development Program.

Recent News Feed

Unmet Need in Antibiotic Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

On March 1, 2016, CTTI hosted a multi-stakeholder expert meeting for its Unmet Need in Antibiotic Development Project. This project is investigating perceptions of antibacterial drugs developed using accelerated pathways. Non-traditional development pathways can expedite the availability of much-needed new antibacterial therapies, but there is a tradeoff in risk and uncertainty.

At the expert meeting, results were presented from focus groups and interviews conducted to elicit opinions from patients, healthy persons, caregivers, and physicians on the use of antibacterial drugs developed using streamlined approaches. Meeting attendees, which included representatives from academia and pharmaceutical companies, patient advocates, regulators, and other stakeholders, discussed ways to improve labeling, risk communication, and public understanding in the context of streamlined antibacterial drug development approaches. This input informed interpretation of the findings and project next steps. We are now pleased to share the meeting materials, which may inform others working to address the serious public health issue of antibacterial resistance.

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

This project is part of CTTI’s Antibacterial Drug Development Program.

Recording Now Available: Webinar on Improving Clinical Trial Recruitment

Posted on by Lorri Bingham

On May 19, 2016, CTTI hosted a webinar on moving recruitment planning upstream to reduce barriers to clinical trial participation. This webinar was the official unveiling of CTTI’s new recommendations and tools resulting from the Recruitment Project. We are now pleased to share the recording from this webinar, in which you can learn more about:

  • A holistic approach that integrates strategic recruitment planning throughout the entire clinical trial process, beginning with study design and development
  • Ways to identify and engage all relevant stakeholders throughout recruitment planning to prevent downstream recruitment challenges
  • Recommendations for trial feasibility, site selection, and developing strategic recruitment communication plans
  • New tools available to aid in strategic recruitment planning

The slides and responses from the webinar’s Q&A session are also available for download.

We encourage you to share these resources with your colleagues in the clinical trials enterprise.

To view recordings of other CTTI webinars, CLICK HERE.

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.