Global Phase Iv Clinical Studies : Challenges And Perspectives Essay

Global Phase Iv Clinical Studies : Challenges And Perspectives Essay

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Global phase IV clinical studies: challenges and perspectives

The phase IV clinical trial also called as a post marketing surveillance (PMS) or late phase clinical trial and it is a very different in design than earlier conducted phase I to phase III studies. Each PMS study considered as a phase IV study but is not true that each and every one phase IV study is considered as post-marketing surveillance (PMS) study (Suvarna, 2010). Phase IV study is as important as phase I to phase III of drug progress. It is conducted after a drug, biologic or device approved from the FDA or related regulatory authority. The structure of this research is a non interventional study to evaluate the safety tolerability in routine clinical practice in a particular population. This study consisting large simple trial, randomized clinical trial with observational study. Phase IV study gives an idea about how drug is marketed and physician are prescribing called the drug utilization studies (DUS). A drug registry or potential observational studies of patients who have a common disease condition give a precise evaluation of clinical performance, patients and relative result.
In phase I, we have established the safety of a new drug, and in phase II the efficacy, while in phase III, we have evaluated new drug with the standard available treatments to verify whether the new drug will give better advantage than standard available treatment. We have examined the scope of these three phases in limited population which raised a number of significant questions that needs to be answered even though the new drug already got approval and registered for the commercial use. A number of significant questions like whether a new drug will benefited to additional patien...


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...o phase III. Pharmaceutical industries are very much excited to conduct phase I to phase III clinical studies compare to the phase IV studies, reason the product is already in the market. Pharmaceutical companies have several objectives at phase IV study stage: (1) to compare the drug benefits against existing drugs available in the pharmacy; (2) to observe a drug 's long duration efficiency and measure the quality of a patient 's living; and (3) to conclude the price-efficiency of a drug treatment comparative to another available treatments. Phase IV study’s findings can put drug or device being ban or limits of use could be placed. Phase IV studies are conducted based on the “real world” situation compared to the cautiously controlled conditions of a phase III study, treatment is given to the individual patients and outcome may put product’s future in problem.




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