The strengths of our trial are that it is a multicentre, multinational, randomised clinical trial with masked outcome assessors.
Design Multicentre, multinational, randomised clinical trial with masked outcome assessment.
We conclude that accelerated BEP merits further evaluation in terms of efficacy: this would require a multinational randomised controlled trial.
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.
3 5 In the Normoglycemia in Intensive Care Evaluation Survival Using Glucose Algorithm Regulation (NICE-SUGAR) multinational randomised control trial, severe hypoglycaemia was 13 times more frequent in the intensively treated group (6.8% vs 0.5%, p<0.001) in which there was found to be a significantly higher 90-day mortality compared with the conventional group.
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).
We screened all multinational randomised controlled trials from http://www.clinicaltrials.gov conducted in the period from 1 January 2005 to 31 December 2010.
Our economic evaluation of XELOX was performed retrospectively, based on patient-level data from two multinational randomised clinical trials, NO16966 and NO16967.
Study design The RENAAL trial was a multinational, randomised, double-blind trial that compared the effects of losartan vs placebo in addition to conventional antihypertensive medication in patients with type 2 diabetes and nephropathy.
This phase III multinational, randomised, double-blind trial initially comprised 9366 PMW with breast cancer (Baum et al, 2002).
