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However, despite the positive phase II data there remains a high failure rate in late stage clinical trials which, in many cases can be ascribed to inappropriate trial design, poor patient selection and inconsistency in patient management.
We defined a traumatic instrumental delivery as an inappropriate trial of labour with a vacuum extractor or forceps in the following circumstances: incomplete cervical dilatation, noncephalic presentation or cephalic malpresentation, nonengaged fetal head or clear indication of cephalopelvic disproportion.
Complex instrumental delivery was defined as an inappropriate trial of labour in a singleton delivery with a vacuum extractor or forceps in the following circumstances: incomplete cervical dilatation, non-cephalic presentation or cephalic malpresentation, non-engaged fetal head, or a clear indication of cephalopelvic disproportion.
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Two studies in which this was attempted had disappointing outcomes [ 69, 70] that may have resulted from inappropriate trials designs.
Many seem to assume that lack of significant differences between active interventions demonstrates equivalence, which is inappropriate in trials designed to test for superiority that are neither designed nor powered to demonstrate non-inferiority.
Crossover study designs are thus inappropriate, and trials are usually conducted with a parallel-group design.
In herbal medicine trials, it would be inappropriate if a trial design does not utilise syndrome differentiation, and participants may not be properly treated.
Even reviews with relatively large numbers of trials and patients could not provide strong evidence because of inappropriate comparison or trial design [ 23] or methodological heterogeneity [ 17].
"To allow the defense to address sexual-history matters of a victim at preliminary hearing, in open court, which are later deemed inappropriate evidence at trial would completely abrogate the Rape Shield Statute and its purpose," Deputy District Attorney Ingrid S. Bakke wrote in a motion filed Tuesday.
Nevertheless, recent studies have shown that transparency is impaired by non-publication or inappropriate publication of trial results.
Out of the 72 selected, patients who did not undergo curative resection (two patients), those who did not receive adequate drug administration (three patients), and whose disease stage was considered inappropriate for the trial (three patients) were further considered ineligible.
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