Author: Hannah Faulkner

New CTTI Paper Outlines Risk Factors to Aid in HABP/VABP Pediatric Trial Enrollment

Posted on by Hannah Faulkner

A CTTI paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

These risk factors are important because they could aid in earlier and more accurate diagnosis of HABP/VABP, alleviating roadblocks to enrollment in HABP/VABP clinical trials. Improved enrollment could help speed the development of new antibiotics for HABP/VABP, which can often be deadly for children.

The paper details a study conducted by the Pediatric Trials Network in collaboration CTTI, which used pediatric patients’ electronic health records to identify which patients received qualifying respiratory support or antibiotics for either a lower respiratory infection or undifferentiated sepsis. The study then followed the selected patients until they were either diagnosed with HABP/VABP or discharged from the intensive care unit.

Of 862 newborns, infants, and children younger than 18 who were evaluated, 10 percent of patients receiving respiratory support and 12 percent overall developed HABP/VABP. While risk factors varied by age group, patients showed increased odds of developing HABP/VABP if they:

  • Were older
  • Were shorter
  • Spent a longer time in the intensive care unit
  • Were at risk of aspiration
  • Had received a blood product transfusion in the prior seven days
  • Had frequent suctioning

Increased attention to patients with these high-risk features could lead to improved identification of eligible participants in HABP/VABP antibiotic trials.

Learn more about CTTI’s work to improve the feasibility of HABP/VABP clinical trials.

Webinar to Provide Findings & Reflections from CTTI’s ICH E6 Renovation Work

Posted on by Hannah Faulkner

As the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) begins revisions to ICH E6 GCP, new CTTI research highlights opportunities for changes and improvements.

CTTI will host a webinar Thurs., March 19, at noon ET providing an overview of new multi-method research to identify areas within ICH E6 GCP that are in the greatest need of renovation. Speakers will include:

  • Fergus Sweeney (EMA)
  • Celia Witten (FDA, CBER)
  • Amy Corneli (CTTI)
  • Dagmar Gortz (Janssen)
  • Pamela Gonzalez (University of Chicago)

CTTI’s research includes the perspectives of more than 350 research professionals in 20 different global regions and describes stakeholder experiences with implementing ICH E6 GCP. Preliminary findings were presented to the FDA and EMA in advance of the first ICH E6 work group meeting in November 2019. Some of the initial findings include:

  • 32.4 percent of respondents use mobile applications for the remote capture of efficacy or safety outcomes data for regulatory decision making
  • 62.1 percent use routine health care data for capture of efficacy or safety outcomes data for regulatory decision making
  • 60-75 percent of survey respondents indicated that renovation is not needed to the general principles
  • Areas identified as needing the most renovation included: Sponsor, Essential Documents, and Investigator. Of less need for renovation were topics in the section on Clinical Trial Protocol and Protocol Amendments.

To hear more, mark your calendar for the upcoming webinar today!

Webinar Now Available: CTTI Resources for Assessing the Value of Patient Engagement

Posted on by Hannah Faulkner

A recording is now available of a CTTI webinar held on Thurs., Feb. 27, which provided an overview of resources that can help you embed patient engagement in your research. The webinar, which was led by Joseph DiMasi (Tufts University) and Jaye Bea Smalley (formerly of Celgene), featured an overview on CTTI’s patient engagement work, including two tools for identifying patient engagement activities that bring high value to both sponsors and patient groups.

DiMasi discussed an economic modelling approach, along with recent findings, that can help sponsors and academic researchers measure the financial return on investment associated with patient engagement activities. The model developed by CTTI estimates the value of patient engagement on key business drivers such as cost, risk, revenue, and time. In a hypothetical scenario of oncology drug development, this model showed that benefits clearly outweighed the costs of engaging patients in clinical trials.

Smalley walked webinar attendees through another CTTI tool that helps sponsors and patient groups identify high-value opportunities to work together. The tool supports both groups in identifying potential engagement opportunities across the R&D continuum, qualitatively evaluating costs and benefits, and agreeing on activities to pursue through collaborative discussion.

Explore additional CTTI work and resources associated with patient engagement on its Patient Groups & Clinical Trials project page.

Are you already using CTTI’s PGCT resources? We would love to hear your experience and feedback!