Informed Consent
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CTTI Project: [Project]
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Meeting Location:
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Meeting Materials:
[Agenda]
[Meeting Summary]
[List of meeting attendees]
Meeting Presentations:
- Presentation 1
- Presentation 2
- Presentation 3
- Presentation 4
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.
New CTTI Publication Highlights Stakeholder Preferences for Informed Consent Language in HABP/VABP Studies
A peer-reviewed article recently published in JAMA Network Open details CTTI work to get stakeholder feedback on informed consent language for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) studies. The article describes the process of gathering feedback from 52 stakeholders to identify the most important elements to include in the informed consent process.
Previous CTTI research suggested that an early enrollment strategy using advance consent in pneumonia antibiotic trials is acceptable to key stakeholders. As part of that research, CTTI also engaged these stakeholders to identify, describe, and reach consensus on essential concepts that should be included in an advance consent form for a HABP/VABP clinical trial. Concepts were:
- Reassurances on patient health and treatment
- Reasons for advance consent and enrolling early
- Explanation of non-inferiority
The proposed consent language developed in this process, in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset, may help potential participants make informed decisions about their involvement in clinical research. It may also improve enrollment rates in trials from which data are urgently needed to evaluate new treatments and improve patient care.
Learn more about past CTTI work on HABP/VABP.
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