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The fundamental question is how the knowledge and expertise from randomized clinical trials can be applied in various clinical settings in real life.
It is not known how knowledge from intensive interventions of randomised clinical trials can be applied in various real-life clinical settings with limited resources.
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Eligibility criteria relate to the external validity of the study, assisting the clinician to decide whether the results of the trial can be applied to his own patients.
However, this implicitly assumes the eligible patient population to which information from a trial can be applied across a time horizon are independent of time for trial accrual, follow-up and analysis.
Although these design characteristics should enhance the external validity of this trial, the question of how broadly trial results can be applied more generally has implications for implementation into practice.
Once trial design elements are defined, a learning and confirming trial paradigm can be applied to more fully assess candidate therapies, incorporating adaptive Phase I/II study designs, modeling of the relevant dose exposure response targets, and projecting the appropriate population/goal of treatment-specific Phase III confirmatory studies.
The extent to which the trial results can be applied in other contexts will probably depend on the existence and organisation of primary care services.
Based on the principles used to consider whether trial evidence can be applied to an individual patient [ 15], two necessary assumptions are: i) the baseline risk of disease events in the new population is high enough to warrant treatment, and ii) existing trial evidence about treatment effectiveness can be applied to this population.
Because no reason exists why the standards for a meta-analysis should be less rigorous than those for a single trial, analogous trial sequential monitoring boundaries can be applied to meta-analysis as trial sequential analysis.
Because there is no reason why the standards for a meta-analysis should be less rigorous than those for a single trial, analogous trial sequential monitoring boundaries can be applied to meta-analysis.
In the same manner, trial sequential monitoring boundaries can be applied to meta-analyses.
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