intention to treat

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intention to treat

In clinical trials, the principle that holds that the effect of a treatment regimen can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen), rather than the actual treatment given. Thus, subjects allocated to a treatment group should be followed, assessed and analysed as members of the treatment group irrespective of their compliance with the planned course of treatment. The principle of intention to treat is meant to prevent bias caused by loss of trial participants, which may reflect non-adherence to the protocol and disrupt baseline equivalence established by random assignment.
References in periodicals archive ?
Tecentriq in combination with chemotherapy met the primary endpoint of overall survival as compared with chemotherapy alone in the intent to treat analysis.
LOI was defined as a SLEDAI increase >=4 points or a new BILAG A or B score and physician intent to treat with rescue medication.
According to the company, the study failed to indicate a statistically significant difference from placebo in the intent to treat population.
We added a time-dependent interaction effect with the radiotherapy indicator to assess the consistency of our main findings (overall, low and high risk intent to treat results) over time.
The results on the intent to treat (ITT) population demonstrated that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo, which was the trial's primary endpoint.
Improvements in global function were also evaluated as a coprimary study endpoint and were not found to achieve statistical significance, as evaluated by changes from baseline in the Clinician's Interview-Based Impression of Change Plus Caregiver Input scores (4.23 vs 4.29; intent to treat, P = .1789).
Thoratec said forty-six percent of the HeartMate II patients successfully achieved the primary composite endpoint of survival at two years while remaining free from disabling stroke or the need for reoperation to replace or repair the pump versus 11% of the SVE patient cohort, on an intent to treat basis.
Moreover, the phrase "symptoms for which you received medical care" connotes an intent to treat or uncover the particular ailment that causes that symptom--even absent a timely diagnosis--rather than some nebulous or unspecified medical problem.
["Intent to treat" analysis compares the total percent of volunteers who meet the study-defined success criterion alter being assigned to take one drug vs.
Blood samples that were taken every 2 weeks showed that the supplement significantly slowed the rate of PSA increase in both an intent to treat analysis of 46 patients who had at least two serum PSA readings per treatment and an analysis of 42 patients who had five PSA readings per treatment as called for in the protocol.
Despite the assurances he gave to Russ Feingold during confirmation hearings, saying that he "had no intent to treat this group [gays and lesbians] differently than any other," Ashcroft forbade a gay-pride awards ceremony that had been scheduled for June 18 and that had been an annual observance for the past six years.