BACKGROUND The Consolidated Standards for Reporting of Trials (CONSORT) statement is a device to standardize reporting and improve the quality of controlled trials. The aim of this study is to determine the quality of controlled clinical trial reports by national peer-reviewed journals in Iran. METHODS In a cross-sectional study, we evaluated clinical trial reports by national peer-reviewed I...

Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched PubMed for RCTs comparing a FDC with the same active drugs administered as separate pills, including a...

BACKGROUND Institutional Review Board (IRB) members have a duty to protect the integrity of the research process, but little is known about their basic knowledge of clinical research study designs. METHODS A nationwide sample of IRB members from major US research universities completed a web-based questionnaire consisting of 11 questions focusing on basic knowledge about clinical research stu...

In this issue of PLoS Medicine, Doshi and colleagues argue that the full clinical trial reports of authorized drugs should be made publicly available to enable independent re-analysis of drugs’ benefits and risks [1]. We offer comments on their call for openness from a European Union drug regulatory perspective. For the purpose of this discussion, we consider ‘‘clinical study reports’’ to compr...

Randomized controlled trials (RCTs) are increasingly playing a central role in shaping policy for development. By comparison, social experimentation has not driven the great transformation of welfare within the developed world. This introduces a range of issues for those interested in the nature of research evidence for making policy. In this article we will seek a greater understanding of why ...

The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodol...

' 2004 Canadian Medical Association C are presented with problems that require evidence. Randomized controlled trials (RCTs) are considered the optimal study design for evaluating the effect of a new medical or surgical intervention. Surgical RCTs are carried out less often than RCTs of medical interventions, partly because using RCTs to evaluate surgical or interventional procedures is difficu...

To determine the optimum duration of follow-up for the assessment of drug efficacy against Plasmodium falciparum malaria, 96 trial arms from randomized controlled trials (RCTs) with follow-up of 28 days or longer that were conducted between 1990 and 2003 were analyzed. These trials enrolled 13,772 patients, and participating patients comprised 23% of all patients enrolled in RCTs over the past ...

There are many challenges to be faced when conducting randomized controlled trials (RCTs) in pediatric research. One important challenge is the determination of an appropriate sample size. Recruiting more children than necessary risks unnecessary overexposure of children to an inferior treatment, whereas underestimating the sample required will lead to inconclusive or unreliable results. Both o...

Purpose N-of-1 trials have been used in medicine to generate treatment information when evidence from randomized controlled trials (RCTs) is not available or applicable. Nof-1 study design maintains the methodological safeguards provided by RCTs (blinding, randomization and controls) yet avoids the disadvantages associated with large trials. A standardized method of reporting of N-of1 trials, s...