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The approval was based on phase III multinational, randomized trial METRIC [ 56, 57].
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That said, we agree that the single-trial metric of LFP ERP latency does seem like a nice innovation.
The STE, a trial-level metric, is a useful measure because it provides information on the surrogate endpoint in the units of the surrogate and therefore could be used to inform drug registration and drug reimbursement decisions that are based on surrogate endpoints.
We used number of successful strikes (strikes leading to consumption) per 10 min trial as our metric of consumption rate.
The METRIC trial achieved National Health Service research ethics committee (NHS REC) approval in September 2013 (13/SC/0394) and is being conducted in accordance with the principles of Good Clinical Practice (GCP).
The METRIC trial is a multi-centre prospective cohort study comparing the diagnostic accuracy of MRE and USS for the presence, extent and activity of small bowel Crohn's disease.
In the context of psoriasis trials, the key metric around which decisions are taken is the improvement in Psoriasis Area Severity Index (PASI) in patients during therapy.
Enrolment start date for each trial was the time metric.
While the absolute proportions of patients achieving this degree of weight loss in clinical trials are an important metric for regulatory bodies, differences in lifestyle programmes between trials can make comparisons difficult.
Regina Jacobs won the women's 1,500 and 5,000 at the trials, but said she intended to run only the metric mile.
Given the development of a suitable regression-based transformation, TTU regression permits conversion of outcomes commonly used in clinical trials into the common metric of QALYs.
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