When the aim of the randomized controlled trial (RCT) is to show that one treatment is superior to another, a statistical test is employed and the trial (test) is called a superiority trial (test). Often a nonsignificant superiority test is wrongly interpreted as proof of no difference between the two treatments. Proving that two treatments are equal in performance is impossible with statistica...

AIMS Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions. METHODS AND RESULTS Direct stenting, particularly in conjunction with transradial int...

Co-administration of meningococcal serogroups A, C, W-135 and Y conjugate vaccine (ACWY-TT) with seasonal influenza vaccine was investigated in a subset of adults enrolled in a larger study evaluating lot-to-lot consistency of ACWY-TT and non-inferiority to licensed tetravalent meningococcal polysaccharide vaccine (MenPS). Subjects in this sub-study were randomized (3:1:1) to receive ACWY-TT al...

Typically any new vaccine (or for that matter any new drug) has to undergo phase 1 (early safety and dosing study), phase 2 (safety, dosing and immunogenicity study) and phase 3 (field efficacy and further safety study) trials before being licensed(2). In case one brand of the concerned vaccine with satisfactory efficacy data is already licensed, and serological correlates of protection for the...

BACKGROUND The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical trials, and the subjective factors affecting the interpretation of clinical trial data. METHODS Meetings of t...

AIMS To compare the efficacy and safety of two insulin intensification strategies in patients with type 2 diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone. METHODS A multinational, randomized, open-label trial that compared insulin lispro low mixture (LM25; n = 236) twice daily with a basal-prandial regimen of insulin glargine once daily and insuli...

This paper proposes to use a fuzzy entropy based feature selection approach to reduce the dimensionality of DAIS hyperspectral data. To compare its performance, three other filter based feature selection approaches were used. A support vector machine was used as a classification algorithm. In order to compare various feature selection approaches with full dataset, McNemar’s test based test for ...

The efficiency and safety of a new treatment is occasionally evaluated using Poisson distributed count data as the criteria in clinical studies. In such scenarios, non-inferiority tests using Poisson distributed count data are often employed and evaluated in frequentist frameworks. However, in our previous work, we proposed and presented an index that demonstrated that the Poisson parameter obt...

We first confirm the notions of Pareto optimality, superiority, and inefficiency. Then, we discuss a definition of the measure of Pareto superiority. keyword Pareto superiority/inferiority, Nash equilibrium, Wardrop equilibrium