T he importance of clinical trials in children in providing a scientific evidence base for drug therapy is accepted by health professionals, regulatory authorities, the pharmaceutical industry, and the parents of children. Legislation in the USA alongside government investment in research has resulted in a significant increase in paediatric clinical trials in North America. European legislation...

Several studies reported that moxibustion was effective in treating constipation. This systematic review assesses the clinical evidence for or against moxibustion for treating constipation. Twelve databases were searched from their inception to March 2010. Only randomized clinical trials (RCTs) were included if they compared moxibustion with placebo, sham treatment, drug therapy or no treatment...

Few would argue with Bill Gates when he describes vaccination as “the most effective and cost effective health tool ever invented” [1]. To date vaccination has saved many lives and has the potential to save millions more, especially if vaccines are developed against the “big three”: malaria, HIV, and TB [2-5]. Vaccine development, however, comes at a price that is not only financial but societa...

In recent years, so-called "effectiveness studies," also called "real-world studies" or "pragmatic trials," have gained increasing importance in the context of evidence-based medicine. These studies follow less restrictive methodological standards than phase III studies in terms of patient selection, comedication, and other design issues, and their results should therefore be better generalizab...

Due to the scarcity of randomized clinical trials (RCTs) in nephrology [1], particularly in dialysis, there has been uncertainty about optimal practices. Using standardized data collection, the Dialysis Outcomes and Practice Patterns Study (DOPPS) has shown very large betweenand within-country differences in hemodialysis (HD) practices and patient outcomes. These observational data are especial...

The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculati...

To appraise the current reporting methodological quality of randomized clinical trials (RCTs) in 3 leading diabetes journals.We systematically searched the literature for RCTs in Diabetes Care, Diabetes and Diabetologia from 2011 to 2013.Characteristics were extracted based on Consolidated Standards of Reporting Trials (CONSORT) statement. Generation of allocation, concealment of allocation, in...

Clinical trials constitute one of the main sources of medical knowledge, yet trial reports are difficult to find, read, and apply to clinical care. Reasons for these difficulties include the lack of a common, standardized, structure for trial reports; the restricted length of reports; and limited computer support for use of the literature. We propose a new model of reporting clinical trials, in...

Randomized clinical trials of new coronary devices, as with other novel therapies, are generally conducted in a homogeneous and usually low-risk population. There is valid statistical and methodological justification for this approach, including lower variances (resulting in increased statistical power) and increased probability that observed differences are due only to the study therapy. Altho...

A relatively high burden of influenza is experienced by young children. In order to successfully tackle the burden of influenza in children, effective vaccines are necessary. Accumulated evidence on the efficacy and effectiveness of traditional inactivated split or subunit trivalent influenza vaccines points towards no significant protection in the youngest children, who are largely unprimed. A...