What value for the phase IV clinical trials?

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What value for the phase IV clinical trials?

Phase IV of clinical trials also named post marketing studies or real world trials, are useful to better understand the true efficacy of medicines. Phase IV could improve scientific knowledge i.e. side effects, use of a drug in special conditions, better precision of the dosage. But some studies are more designed for economic purposes facilitating product promotion. So there are several kinds o...

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Phase III and IV clinical trials: what you and your patients need to know.

Note: This column is made possible through an educational grant from CChange, a Washington, DC, based organization comprising the nation’s key cancer leaders from government, business, and nonprofit sectors. These cancer leaders share the vision of a future where cancer is prevented, detected early, and cured or is managed successfully as a chronic illness. The mission of C-Change is to leverag...

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Pilot trials in clinical research: of what value are they?

P ilot trials are exploratory studies limited in size and scope that give insight into the actions, efficacy, and safety of a drug or device but cannot provide definitive support for specific mechanistic or therapeutic claims. Defined in this way, pilot trials have been used to guide clinical and translational research for many years. As studies defined as pilot trials are regularly published i...

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Phase I clinical trials

Phase I trials are conducted to find a dose to use in subsequent trials. They provide data on the rate of adverse events at different dose levels and provide data for studying the pharmacokinetics and pharmacology of the drug. Dose-finding studies that involve therapies with little or no toxicity often enroll healthy volunteers and usually have a control group. Trials in oncology and other life...

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Clinical trials: what a waste.

Randomized controlled trials are the gold standard tool for evaluating interventions. Nevertheless, the utility of this excellent tool is contingent on how it is used. Chapman and colleagues (doi:10.1136/bmj.g6870) show this in a sample of 395 trials relevant to surgical practice that were registered in ClincialTrials.gov between 2008 and 2009.By the end of 2013, 21%were discontinued, 34% of th...

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ژورنال

عنوان ژورنال: SOJ Pharmacy & Pharmaceutical Sciences

سال: 2016

ISSN: 2374-6866

DOI: 10.15226/2374-6866/3/2/00138