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The aim of this work was to reach a consensus on the most appropriate endpoint to consider in future clinical trials evaluating the efficacy of antimicrobial treatment for HAP VAP, using Delphi method.
Importantly, it should be recognised that the absence of a clear mechanism for the cytogenetic action of cadmium compounds did not allow to select the most appropriate endpoint to be examined.
Although ICU mortality is not the most appropriate endpoint to be evaluated, it reflects the pre-ICU and ICU care of septic patients, and in our scenario, identified a more specific point to improve the care of septic patients [31, 32].
All-cause mortality was deemed the most appropriate endpoint for a number of reasons.
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Regulatory guidance documents stress the value of assessing multiple tissues and the most appropriate endpoints when evaluating chemicals for in vivo genotoxic potential.
Functional evaluation and muscle strength would have been the most appropriate endpoints in our study.
Further research is required to enable better assessment of pain and to assist in formulating the most appropriate endpoints.
These parameters are difficult or impossible to control well even in prospective studies due to the overriding concern for patient safety and lack of evidence for the most appropriate endpoints.
Although there has been progress in the integration of multiple endpoints into 28-day repeat dose studies (for example, see [Dertinger et al., 2010; Shutsky et al., 2010]), further work is required in order to determine the most appropriate endpoints, dosing regimes, and sampling times.
It makes little sense to perform a randomized trial to assess the cost-effectiveness of a rapidly morphing technology, whereas patient outcomes and/or cost-effectiveness may be the most appropriate endpoints for a trial of a technology for which reader performance (i.e. accuracy) has been well established.
The authors speculate as to the reasons for this in their article and, as they suggest, the introduction of more effective treatments and clinical management into second-line and subsequent treatment must be considered to play a role. 1 This again raises the issue concerning the most appropriate primary endpoint for phase 3 studies.
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CEO of Professional Science Editing for Scientists @ prosciediting.com