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A first randomized, double-blind, and placebo-controlled phase I/II clinical trial was executed on 24 patients suffering from chronic otitis caused by MDR P. aeruginosa, showing efficacy and safety in the treatment of this infection [ 22].
Subsequent clinical trials were not successful.
Dr. Leon noted that clinical trials were pending.
It is important to be aware of the potential effects of these factors when clinical trials are planned and executed for ARF patients.
Properly designed and meticulously executed clinical trials are essential and required to advance and optimize the potential of non-invasive neuromodulation without risking the well-being of children and families.
Well-designed and executed controlled clinical trials are needed to establish performance characteristics and to address issues that are unique to CMBCS.
Results of the Alzheimer's clinical trial are expected early next year.
But clinical trials are difficult to perform with children.
Because clinical trials are complex endeavors, groups of stakeholders charged with executing specific steps invariably form silos with group-specific methods for completing and documenting their work.
Prospective randomized clinical trials are underway to address the clinical significance of these findings, but there are major challenges in designing, executing, and interpreting such trials.
Clinical trials are an integral part of the development and improvement of pharmaceutical, medical device, and biotechnology products, but they are costly, risky, and difficult to execute.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com