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The trial endpoints, reached at 3 and at 6 months, have previously been reported [8].
Outcome assessments as clinical trial endpoints should be well-defined, reliable, and reflect meaningful treatment benefits.
A 22-question survey was designed using physician input, focus groups, and clinical trial endpoints.
Nevertheless, all vaccines tested to date have failed to meet clinical trial endpoints.
FIS will facilitate the identification of meaningful functional goals and interpretable clinical trial endpoints.
Clinical trials, however, have become a major challenge because of issues with trial endpoints.
This study examines whether these measures increase rectal and urinary dysfunction and are secondary trial endpoints.
Trial endpoints should show clinically meaningful improvements in patient survival or quality of life.
In this Review we discuss the measurement, assessment, and benefits and limitations of trial endpoints in use for cancer treatment.
Regulatory agencies are showing increased concern regarding the cross-cultural suitability of PRO measures that generate data used to support clinical trial endpoints [3, 8, 9].
Historically, clinical studies of RSV-infected infants have relied on symptom scores or other measures, none of which have been validated to be appropriate as clinical trial endpoints.
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