Dying identifications relying on gestures rather than words are often not used in trials because of concern over reliability or differing interpretations.
The significant increase in hospital mortality identified in the liberal transfusion strategy group in the TRICC trial is of concern.
Parents of children with susceptibility to environmental health disorders may favor an environmental intervention in the hopes that it will prevent the onset of an environmental disease, whereas nonaffected members of the community may reject the trial out of concern about group stigma (Fisher et al. 2002).
Epidemiologic studies often depend on self-reported weight and height data, but self-report of anthropometric data is seldom relied upon in clinical trials because of concerns over data quality.
For local chemotherapy using biodegradable wafers, communication of the implantation site and the ventricular system has been an exclusion criterion in the pivotal phase III trials because of concerns that the wafer material may dislocate into the ventricular system, causing obstruction of the CSF pathways [ 3, 21, 23].
Ms. Olson's defense lawyers had sought to exclude any mention of the word "terrorist" in the trial out of concerns that it would prejudice the jury.
However, in this study serious thromboembolic events such as myocardial infarction and cerebral infarction occurred in 7% of rFVIIa-treated patients, as compared with 2% of placebo treated patients (P < 0.05) and the exclusion criteria were changed midway through the trial, because of concerns about safety, to exclude patients with a history of thromboembolic disease [ 47].
As the factory-impregnation of the school uniforms could not be detected via smell or other changes in the textiles, with no obvious reactions to these uniforms found in the first 4 weeks of the trial, the extent of concern about ISUs was low.
Examples include concerns about efficacy and safety of trials, fear of additional financial costs, concern about randomisation, trial burden, loss of confidentiality, dependency issues and cultural barriers.
The trials were halted because of concern that this could increase the risk of HIV transmission.
