obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. in order for the consent to be informed, the patient must receive and comprehend the information appropriately. complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. the objective of this study was to assess the readabil...

ethical consideration is a basic requirement for design of randomized clinical trials. the purpose of this study was to assess whether reports of iranian dental clinical trials complied with the requirements of the ethical principles of human research.in this retrospective observational study electronic search was performed to identify all dental clinical trials published between 2001 and 2011....

free radicals are produced continuously in the cells as part of normal cellular function, however excess production might play a role in pathophysiology of many disease conditions, including cancer, alzheimer's disease, atherosclerosis and some of the drug-induced toxicity. many basic research studies and observational epidemiologic studies in human suggest that antioxidants can prevent oxidati...

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clinical trial committee (ctc) has been established in food and drug organization (fdo), in 2003 to assure efficacy and safety of all types of medicinal products which are meant to be registered in iran drug list and/or obtain market authorization.all clinical trial files, meeting minutes and databases in ctc secretariat in fdo were reviewed. relevant information and data extracted, analyzed an...

background: the study aim was to reports detailed characteristics of nutrition research in field of diabetes, and recognize knowledge gap in nutrition science in diabetes in iran. methods: online databases of pubmed, web of science and scopus as well as national databases including sid, iranmedex, and magiran were searched up to 2015 to identify eligible articles. finally, 378 articles were inc...

conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. herbal medicine may be a suitable alternative. the objective of the manuscript, is determine the efficacy and safety of some iranian herbal medicine for primary dysmenorrhea when compared with placebo, no treatment, and other treatment. for this target ele...

Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways ...

This paper describes many of the challenges encountered when establishing a large multicentre trial in cardiac anesthesia. We address funding, authorship, multisite ethics review, patient recruitment, data quality management, communication with individual sites, and strategies to enhance cooperation and patient recruitment.

Critical appraisal is an element of evidence-based medicine, which is defined as the process of carefully and systematically examining a research article to determine its reliability, validity and value in clinical practice. The major components evaluated in critical appraisal are validity, importancy, and applicability. The level of reliability of study results depend on the design of study, i...