Exact(4)
With respect to RCTs, data from initial pivotal trials were discussed.
After the initial pivotal randomised phase II BOND study which demonstrated the ability of cetuximab to circumvent chemotherapy resistance (Cunningham et al, 2004), a series of randomised phase II III trials for EGFR-targeted monoclonal antibodies (mAbs) have been reported.
The relatively short durations of the initial pivotal randomized placebo-controlled trials involving atomoxetine HCl for the treatment of attention-deficit/hyperactivity disorder (ADHD) provided limited insight into the time courses of ADHD core symptom responses to this nonstimulant, selective norepinephrine reuptake inhibitor.
Owing to registration and commercial obligations, the initial pivotal studies with bevacizumab, sorafenib, sunitinib and pazopanib were carried out using either placebo or IFN as a comparative reference arm (Motzer et al, 2007; Escudier et al, 2007b; Sternberg et al, 2010).
Similar(56)
Adhesion of bacteria to the epithelial cells is believed to be an initial and pivotal event in the pathogenesis of most bacterial enteric infections and is necessary for allowing bacteria to survive and persist in a continuously moving environment and to defeat host defense mechanisms [ 6].
Quantifying wind potential is a pivotal initial step in developing and articulating a state's policies and strategies for offshore wind industry development.
Based on these initial findings two pivotal hypotheses have been formulated and investigated in subsequent studies (reviewed in [ 17]).
The study is being completed in 3 phases (an initial pilot phase, a pivotal phase, and an expansion phase), enrolling 500 patients with New York Heart Association (NYHA) class III and IV systolic heart failure and QRS durations of 130 ms or more.
Other studies have indicated that the initial 6 months are pivotal to outcome and that escape mutations typically occur during this time.
Furthermore, the determination of initial sampling points play a pivotal role in the determination of strain selection as well as strain viability.
Based on the promising results of the initial phase I trials, several pivotal phase II clinical trials evaluating CAR-T cell therapy for B-ALL are underway (US National Library of Science, 2016a, b, c, d, e).
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