Trial results

In humans, biomarker responses to PPAR agonists by and large support possible antiatherosclerotic benefits, although recent clinical trial results have not proven conclusive. Further large-scale trials should help define the role of PPAR agonist therapy on cardiovascular events in at-risk populations. 

The BP-led feedstock recycling consortium recently unveiled its new larger-scale fluidised bed pyrolysis pilot plant, located on the BP refinery site at Grangemouth. The 2 tonne/day plant will take mixed plastics waste from a variety of sources to provide more extensive trial results, to be used in the conceptual design of a 25,000 t/y semicommercial demonstration plant. The consortium envisages a series of plants, of around 25,000-50,000 t/y, scattered across Europe. 

The effects of microsphere size distribution, drug/polymer ratio, and microsphere quality can be easily demonstrated in this laboratory model. Furthermore, as animal data and human clinical trial results are available the model becomes quite useful as a quality control method (46). 

The European/Australian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) confirmed the finding of ESPS 2, showing that the combination of aspirin and dipyridamole is more effective than aspirin alone in the prevention of new vascular events in patients with nondisabling cerebral ischaemia of presumed arterial origin. Adding the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or MI of 0.82 (95% Cl 0.74-0.91). 

When the trial site is not on a special research facility, the evaluation and selection of held investigators (farmers) may be difficult. The best trial results are normally obtained from those trials conducted on farms where the farmers or techni-cians/agronomists involved with the normal application of pesticides on the farm are involved in the conduct of the trial, and are aware of the objectives so that they avoid treating the trial area with products likely to interfere with the analysis. 

In conclusion, H3 ligands offer the attractive vista of multiple applications in various disorders, but the ultimate definition of their therapeutic utility will have to await clinical trial results. Future work will determine whether inverse agonists, neutral antagonists, or protean agonists will constitute the more useful pharmacological intervention. 

AL Dans, LF Dans, GH Guyatt, S Richardson. Users guides to the medical literature XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA 279 545-549, 1998. 

Harris, Gardiner, Maker of Paxil to Release All Trial Results , New York Times, 26 August 2004... 

MLC (Meat and Livestock Commision) (1992), Stotfold Pig Development Unit Second Trial Results, Meat and Livestock Commission, Milton Keynes. 

Proper and comprehensive planning of a clinical trial is essential to the successful development of any drug. The first issue to be considered when developing a trial protocol is to define precisely what questions the trial results should be capable of answering. As discussed previously, the terms safety and efficacy are difficult to define in a therapeutic context. An acceptable meaning of these concepts, however, should be committed to paper prior to planning of the trial. 

However, native antisense oligonucleotides also suffer from a number of disadvantages, which are ultimately responsible for numerous disappointing trial results, and the fact that, after almost two decades of clinical investigation, only a single product has gained approval to date. Disadvantages include ... 

Combination therapy with an ARB and ACE inhibitor offers a theoretical advantage over either agent alone through more complete blockade of the deleterious effects of angiotensin II. However, clinical trial results indicate that the addition of an ARB to optimal HF therapy (e.g., ACE inhibitors, /3-blockers, diuretics) offers marginal benefits at best with increased risk of adverse effects. Addition of an ARB may be considered in patients who remain symptomatic despite receiving optimal conventional therapy. 

Based on clinical trial results demonstrating reduced mortality, low-dose aldosterone antagonists may be appropriate for (1) patients with moderately severe to severe HF who are receiving standard therapy and (2) those with LV dysfunction early after MI. 

Randomized trial results are mixed when candidates for second-line therapy are treated with combinations of antiandrogens plus either LHRH... 

Table 7 Field trial results investigating effects of pyrethroids on honeybees...

Trial results from a small sample of cells are used to put likely bounds on the overall average... 

In many weathering trials results are only available for one set of conditions and strictly no extrapolation can then be made for temperature. The temperature conditions in weathering cabinets can be quite high and if the temperature of service was more modest the predictions could be very misleading. If, additionally, heat ageing results are available then these can be combined with the weathering results. 

Recently there has been progress towards a universal acceptance of collaboratively tested methods and collaborative trial results and methods, no... 

O Shaughnessy, J. et al., Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated paEents with advanced breast cancer phase III trial results, J. Clin. Oncol, 20, 2812-2823, 2002. 

Another practice is to blind the trial, which means that the subjects are not privy to whether they receive the placebo or drug. In some trials, even the investigator is unaware of whether the subject is in the control or active group. This is called a double-blind trial. The rationale is to ehminate the possibihty of bias affecting the trial results. 

Based on the design of the trial protocol, statistics are used to calculate the number of people to be recruited for the trial, how the trial should be randomized (Exhibit 6.12), and finally analysis of the data. Statistics provide a nonbiased means to evaluate the trial results. 

This is the organization that is contracted by the Sponsor to conduct and monitor the trial. It also provides a certain measure of independence to the trial and enhances the validity of the trial results to be unencumbered by conflict of interest. 

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