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The pharmaceutical industry funded 80% of the RCTS we identified, and so it is not surprising that the frequency with which outcomes in the disease activity domain have been measured as primary or secondary outcomes reflects, to some extent, the requirements of the FDA [22], [23] and EMEA [24] [27].
Although PROs are often measured as primary outcomes in clinical trials, challenges remain in their application.
Abdominal fat area and body fat percent were measured as primary outcomes.
Serum enzyme levels of sGOT and sGPT were measured as primary and specific markers of liver injury.
The baseline values of serum and urinary cystatin C were measured as primary parameters and those of urinary nonalbumin protein (NAP) were measured as secondary parameters.
Over the past 15 years the pharmaceutical industry has increasingly included PRO measured as primary efficacy or key secondary endpoints in drug therapy clinical trials (Leidy and Vernon 2008).
Similar(54)
In one of these studies children, aged between 5 and 12 years, were randomised to receive inhaled budesonide, nedocromil sodium or placebo for a period of four to six years, and FEV1was measured as the primary outcome [20].
The ASP was measured as a primary outcome measure.
Participants' usage with the site was measured as the primary outcome.
CLCR was measured as the primary method of determining kidney function.
Changes in disease status as evaluated by clinical signs or any available tool will be measured as the primary outcome.
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