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Safety and efficacy is prime most aspect in medical practices aided by clinical trials. It maintains the set of regulations and procedures that evaluates the effectiveness and safety of the diagnostic products, devises and medications intended for human use. These guidelines are in compliance with the international standards in testing novel drugs, procedures and devices begin with animal trials followed by human trials. The current volume 6 issue 5 of this journal had published editorial, short commentary, protocol, research articles which are of current medical practices.
The TIME study is a randomized, open label and blinded end point controlled clinical trials. It is built using C#. Net program and a structured query language (SQL) server 2008 database and it assure the best security practices. These advanced technologies were employed to track the patient outcome and record linkage to evaluate the morbidity and mortality rate among the study populations. Study of Rorie et al. was sought to establish the feasibility of detecting whether evening dosing of antihypertensive is more cardio protective than morning dosing. This study was sponsored by British heart foundation and the results were seems to be sustainable .
Phase III randomized clinical trials (RCT) offer the best approach for providing safety data, adverse events (AEs) are routinely collected data during the course of the trial, it is often required to determine AEs association with treatment. Jacob et al., study tried to illustrate advantage of Bayesian model in achieving reliable information using data of a randomized clinical trial (RCT) in evaluating chemotherapies against acute promyelocytic leukaemia. The results of the study state that among 10 intended journals five were found to have published results from RCTs in the study period and Bayes modelling was the best to provide legitimate information on the AE distribution in a RCT .
Dakka et al. in the case report detailed the causes of seizures and hemiparesis in Dyke Davidoff Masson syndrome (DDMS). DDMS was first described by Dyke et al. in 1933. DDMS refers to the mutilation to the developing brain in early childhood period or fetal and subsequent clinical features may vary based on the extent of brain injury. DDMS commonly existent with recurrent seizures, language disorders, learning disability, contralateral hemiplegia, speech and facial asymmetry. The cerebral hemiatrophy, calvarial thickening, and hyperpneumatiztion of the frontal sinuses are the classical radiological diagnostic measures. This study presents a case of 54-year-old male and another case of a 46- year-old male .
The presented study of Ford et al. was intended to analyse blinded independent central review (BICR) data from 70 oncological clinical trials. BICR is supportive to the regulatory authorities as a means of curtailing bias when the data is intended to support crucial trials. The study concludes that the adjudication factors had multiple enslavements and which can be predicted based on modelling of allied factors .