Zilver PTX was recently evaluated in a large multicenter, multinational randomized, controlled trial and a complementary multinational, multicenter, single-arm clinical study [ 13– 15].
Following a multinational randomized controlled trial, Molyneux et al.
We conclude that accelerated BEP merits further evaluation in terms of efficacy: this would require a multinational randomised controlled trial.
rFVIIa has indeed been tested in a multicenter multinational randomized controlled trial [ 7] and was shown to decrease hematoma enlargement, disability, and 90-day mortality.
However, the establishment of international consortia, and the first multinational randomised controlled trial, have paved the way for major progress in the near future, underpinned by growing interest from the pharmaceutical industry.
In a phase III, multinational, randomized controlled trial (CLEOPATRA-PD) [ 41], the pharmacokinetic profile of rotigotine following removal and reapplication of transdermal patches was examined in 56 patients with advanced-stage PD [ 42].
To clarify this controversy, the CRISTAL trial (Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial), a large ongoing RCT, is evaluating the efficacy and safety of any type of colloids versus crystalloids for fluid resuscitation in critically ill patients (clinical trials number NCT00318942).
We screened all multinational randomised controlled trials from http://www.clinicaltrials.gov conducted in the period from 1 January 2005 to 31 December 2010.
Therefore and while the cost data in particular cannot be taken from multinational randomized controlled trials (RCTs), a macro-costing approach was chosen for this analysis to generate cost data from other sources [ 19].
Nevertheless, the published idebenone study demonstrated that multicentre, multinational randomised controlled trials are possible in mitochondrial disease, laying the foundation for the five trials ongoing in the United States studying a range of different compounds in different mitochondrial disorders (ClinicalTrials.gov) (Table 1).
