Marzi, A. et al. Stat1-deficient mice are not an appropriate model for efficacy testing of recombinant vesicular Stomatitis virus-Based Filovirus Vaccines.
The development of serologic assays to detect recent HIV-1 infection and to estimate HIV-1 incidence has generated widespread interest in applying this approach to monitor the HIV epidemic [1] [4] and to identify appropriate populations for efficacy trials.
The randomized controlled trial evidence underpinning dabigatran's marketing authorization resulted in uncertainty about the appropriate dose for efficacy versus safety.
In addition, most participants (75%, n = 190) who were aware of EC did not know about the appropriate interval for efficacy between unprotected sex and taking EC (Table 1) (based on recent evidence we considered this interval to be up to 72 96 hours after sexual intercourse) [ 13].
We have explored the potential of this animal system for studies of AHSV infection and found that mortality rates, clinical signs and viraemia levels are appropriate for vaccine efficacy studies.
However, these measures would have been appropriate for an efficacy trial, whereas this effectiveness study aimed to measure outcomes in a pragmatic setting.
Randomized controlled trials are more appropriate for defining efficacy and assigning causality, but their external validity or generalizability can often be low [ 34] and they are rarely sufficiently large or long running to identify all adverse events [ 35, 36].
In contrast, the European norm (EN) 13727 requires the use of four different test organisms (Escherichia coli (k12) NCTC 10538, Pseudomonas aeruginosa ATCC 15442, Staphylococcus aureus ATCC 6538 and Enterococcus hirae ATCC 10541) which may not always be appropriate for the efficacy evaluation [ 18].
A major focus of the work was to achieve a selectivity profile appropriate for in vivo efficacy studies and safety.
Although this design is not appropriate for conclusions about efficacy or for making causal inferences, it is helpful for understanding how a Lean implementation can relate to psychosocial work environment changes in the real world.
