Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 36, No. 4, April, 2021
Back Issues
Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.
Excerpt from pg. 3 … IRBs and Hospital-Acquired Bacterial Pneumonia (#2)
“We continue here with more tips for IRBs and researchers for experiments in a field receiving more attention due to COVID; namely, pneumonia associated with the increased use of ventilators for COVID patients.
The new final guidance from FDA is titled “Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.” We resume where we left off last month with more recommendations on how to show efficacy in applicable clinical trials.
“The Agency generally expects sponsors to conduct two adequate and well-controlled trials in HABP/VABP [hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia] to establish substantial evidence of effectiveness.
Alternatively, a single adequate and well-controlled trial in HABP/VABP with confirmatory evidence (e.g., the results of a trial in another infectious disease indication) can provide substantial evidence of effectiveness” (guidance, June, 2020, p. 3; on the Web at https://www.fda.gov/media/79516/download).”