Effectiveness trials

Singh S, Singh B, Reda D, et al. [Abdellatif M]. Comparison of sotalol vs. amio-darone in maintaining stability of sinus rhythm in subjects with atrial Fibrillation (Sotalol-Amiodarone Atrial Fibrillation Effectiveness Trial [SAFE-T]). Am J Cardiol 2003 92 468-72. 

Meyer, J. M., Nasrallah, H. A., McEvoy, J. P., Goff, D. C. et al. (2005). The clinical antipsychotic trials of intervention effectiveness trial clinical comparison of subgroups with and without metabolic syndrome. Schizophr. Res., 80, 9-18. 

The trial burn can be seen as the test drive of the incinerator. It is the time when the owner/ operator will bring the unit up to operational readiness, monitor the key operating conditions, and measure the emissions. The trial burn test conditions are based on the operating conditions proposed by the permit applicant in the trial bum plan submitted to U.S. EPA for evaluation. U.S. EPA establishes conditions in the permit necessary to conduct an effective trial bum, meaning that the burn will be representational of the incinerator s intended day-to-day operation and will yield meaningful data for analysis. 

BV being an infectious disease, antibiotics represent the logical therapeutic approach [39]. However, a high spontaneous cure rate in some patients without symptoms has been found [40], For this reason, placebo-controlled groups are recommended for antibiotic effectiveness trials. Besides systemic toxicity [4], antibiotic treatment... 

Pre-approval safety and efficacy clinical studies involved product administration to 2500 adults with either type-1 or -2 diabetes. The primary efficacy parameter measured was glycaemic control (as measured by the reduction from baseline in haemoglobin Ale). Hypoglycaemia was the most commonly reported adverse effect. Trials also showed a greater decline in pulmonary function in the Exubera group, and product should not be administered to patients with underlying lung disease, or to smokers. Exubera was developed by Nektar Inc. and is marketed under licence by Pfizer. 

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

Mutabingwa TK, Anthony D, Heller A, Hallett R, Ahmed J, Drakeley C et al. Amodiaquine alone, amodiaquine-i-sulfadoxine-pyrimethamine, amodi-aquine-i-artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children a four-arm randomised effectiveness trial. Lancet 2005 365(9469) 1474-80. 

Stenting and Antithrombotic Regimen Choose Between 3 High Oral Doses for Immediate Clopidogrel Effect) Trial. Circulation 2005 I 12 2946-2950. 

Consider first the filamentation effect. Trials of many complexes established that mainly those complexes which were neutral and had no electrically charged ions in solution, markedly inhibited cell division in bacteria. The cts-configuration was active, the trans was not. They did not inhibit growth unless the concentrations were greatly increased. They were associated in the cell primarily with nucleic acids (RNA and DNA) and with some soluble proteins. 

On the basis of the results of effectiveness trials and the toxicity of the drug in human and animal studies, a benefit-to-risk assessment of the drug should be... 

There are many ways to build a model of the crystal structure of a polycrystalline material without first using the intensities of individual Bragg reflections, which are hidden in powder diffraction due to partial or complete overlapping. Most of the direct space approaches are, in effect, trial-and-error methods and they include some or all of the following components ... 

The tension between the conflicting goals of validity in efficacy trials and generalizability in effectiveness trials is illustrated in Fig. 9-2. For example, in an efficacy trial, subjects are selected using narrowly defined eligibility criteria and are monitored closely to ensure that they use or are exposed to the intervention in the manner defined in the trial s protocol and are cooperative with medical advice. In clinical practice, patients are not selected, and the manner in which the patient uses the intervention may vary widely from the intended use for which it was approved. Clinical outcomes among RCT subjects often are better than in nontrial patients. Trials to evaluate therapeutic effectiveness in clinical practice are difficult or expensive for researchers. If results from an effectiveness study are inconclusive, such results could be due to a lack of the intervention s efficacy, patient behavior (such as lack of patient adherence), or both. 

FIGURE 9-2. Schematic drawingshowing the tension between conflicting goals of validity in efficacy trials and generalizability in effectiveness trials. 

Sussman D, Garely A. Treatment of overactive bladder with once-daily extended-release tolterodine or oxybutynin The Antimuscarinic Clinical Effectiveness Trial (ACET). Curr Med Res Opin 2002 18 177-184. 

When testing dispersant effectiveness in the field, it is very difficult to measure the concentration of oil in the water colnmn over large areas and at frequent enough time periods. It is also difficult to determine how much oil is left on the water surface as there are no methods available for measuring the thickness of an oil shck and the oil at the subsurface often moves differently than the oil on the surface. Field effectiveness trials, laboratory effectiveness tests, and factors influencing the effectiveness of a dispersant will be discussed in the following sections. 

Efforts were also made to evaluate whether the supplementary intake of nutrients included in the MeD could also be a health-protective policy. The most effective trial in establishing such information was the GISSl-Prevenzione trial which was focused on fish-derived n-3 fatty acids supplementation. The trial was conducted on 11,324 patients who had a first acute coronary syndrome and followed for a period of 3.5 years. The patients were randomly stratified in four groups the first receiving 1 g of n-3 fatty acids per day the second a supplement of 300 mg vitamin E per day the third both supplements and the fourth only dietary guidelines. The data analysis revealed that the first group receiving only 1 g n-3 fatty acids supplementary had a lower risk of secondary CVD. 

Many iron-fortified products have been tested for the compatibility of the fortificant with the food vehicle and for the bioavailability of the fortified iron, but few efficacy or effectiveness trials have been done. Iron-fortified fish sauce, sugar, infant formula, and infant cereal have been shown to improve iron status. In contrast, attempts to fortify cereal flours with iron have met with little success because they contain high levels of phytic acid and the characteristics of these foods require the use of poorly bioavailable iron compounds. 

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