Blind submission

Modem and ancient chemists have one thing in common their method. What is this method, as old as the science itself, and which has characterized it from its very beginnings It is a total faith in the testimony of the senses it is an unbounded confidence placed in experience it is a blind submission to the power of facts. Ancient or modem, chemists want to see with the eyes of their physical body before employing those of the mind they want to make theories for the facts and not seek out facts for any preconceived theories. ... 

After the submission of this paper several publications have appeared in the literature that reinforce the role of rifaximin in the treatment of infectious diarrhea [1]. An entire issue of the Journal of Travel Medicine devoted to the use of this antibiotic in the treatment of traveler s diarrhea (TD) has been published [2-5], In addition, a recent paper from our laboratory [6] confirmed the rifaximin efficacy also in enteroaggregative Escherichia coli-mediated TD. Furthermore, in a randomized, double-blind, placebo-con-trolled study [7] even once daily administration of the antibiotic proved to be capable of preventing TD. Finally, Lawler and Wallace [8] recently reviewed the treatment options for bacterial diarrhea and considered rifaximin a useful addition to our therapeutic armamentarium. 

These facts must be kept in mind when evaluating the efficacy data with this antidepressant. The best evidence supporting this warning is the recent approval of the sustained release version of bupropion. Three double-blind studies were done to support the submission of this formulation for approval. The FDA concluded that all three of these studies failed to show that the sustained release version of bupropion in the doses used (i.e., less than 450 mg per day) was superior to placebo in the treatment of outpatients with major depression (bupropion summary basis of approval). As a result, this formulation was approved on the basis of bioequivalence with the immediate release formulation. The FDA in its approval documents did not specify why it chose to approve this formulation without efficacy data. One possibility is that there are reasons to believe that the sustained release formulation is less likely to cause seizures than is the immediate release version at comparable doses. In contrast to these failed studies, two relatively small studies published in 1983 reported that immediate release bupropion at doses up to 600 mg per day was superior to placebo in the treatment of inpatients hospitalized for major depression (165, 166). 

What is the impact of this more complex model on drug testing and submissions The current causality model assumes that randomly dividing disease victims into two (or more) groups and administering a therapy in a double blind design will determine whether or not the therapy is effective. But if the... 

An important part of the sampling methodology relates to the use of control samples in order that the data can be quality controlled and quality assured (see Johnson et al., 2008). While it is only duplicates that are created during the sampling process, these, along with replicates, blanks (for waters) and secondary reference materials need to be assigned sample numbers so they are included as part of the routine sample submission and are blind to the analyst. Duplicate samples are collected from a... 

From only two blind trials, one cannot draw definitive conclusions. However, in both challenges the Fourier correlation approach of Katchalski-Katzir yielded the best submission which suggests that it must be considered as a valuable strategy for macromolecular docking. 

On completion and submission of fhis blind-sample PEI study to Ford, it was revealed that die ZDDP, concentration of ZDDP, and die base oil used in each engine oil were die same. Moreover, one of the oils had no additives present other dian die ZDDP. 

Ameyaw-Akumfi and Hazlett (1975) were the first to report a sex pheromone in crayfish. When tested in an aquarium Procambarus clarkii males showed submissive behavior (chelae down, telson curled) in response to female water and displayed aggressive behavior (raised chelae) in response to male odor (Ameyaw-Akumfi and Hazlett 1975). The authors suggested that these differential responses were caused by sex specific pheromones. This study was criticized by Dunham (1978) due to the lack of controls and blind observations. Subsequent studies produced contradictory findings and generated a debate about the significance of pheromones in crayfish (for review see Bechler 1995). 

To each laboratory to which at least 100 specimens are sent in a year, the employer or C/TPA must send the equivalent of one percent of the specimens sent to the laboratory, up to a maximum of 50 blind specimens per quarter. The submissions must be spread evenly throughout the year. 

The cardiovascular safety outcomes of interest must be defined for all Phase n and Phase III trials, prospectively adjudicated by an independent clinical endpoint committee in a blinded fashion, and analyzed before submission of an NDA or... 

Adaptive methodologies, such as sample size or outcome re-estimations and early stopping decision rules, could be specified in the statistical analysis plans for cardiovascular safety outcome trials, potentially to reduce study duration, increase the chances of success, and facilitate earlier submissions. Many different types of adaptive designs are in use. The most common adaptation is to increase the sample size if the rate at which outcomes are accruing is slow. This modification raises no statistical issues if done in a blinded manner. 

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