Equipoise clinical research

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  • Citation tools Download this article to citation manager Moher David , Hopewell Sally , Schulz Kenneth F , Montori Victor , Gøtzsche Peter C , Devereaux P J et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials BMJ 2010; 340 :c869
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    The ethics of clinical research requires equipoise--a state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment. The current understanding of this requirement, which entails that the investigator have no "treatment preference" throughout the course of the trial, presents nearly insuperable obstacles to the ethical commencement or completion of a controlled trial and may also contribute to the termination of trials because of the failure to enroll enough patients. I suggest an alternative concept of equipoise, which would be based on present or imminent controversy in the clinical community over the preferred treatment. According to this concept of "clinical equipoise," the requirement is satisfied if there is genuine uncertainty within the expert medical community--not necessarily on the part of the individual investigator--about the preferred treatment.

    Recent reports suggest that as new experimental treatments for cancer are being developed there is a paucity of participants available to enter trials, especially for rare cancers. 2 So, patients who do get involved in clinical trials can be assured that they are contributing in important ways to medical knowledge, and will receive good care as part of being in a trial. How can one learn about clinical trials? Sometimes health care providers, especially if they are part of large research centers, will be a point of contact for these. is a database of clinical studies that can connect patients, their family members, and health care providers around the world with potential research studies on a variety of diseases and conditions. It is a government web site that does not receive funding or advertising from commercial entities or display commercial content. Available trials involve medical and psychological interventions for people with or at risk for cancer. is another more general site that helps recruit human research participants.

    Confirmatory trials are conducted to provide a definitive answer regarding the safety and efficacy of an intervention or to compare the effectiveness of two or more interventions.  The proposed research must address a scientifically important question, provide valuable information to the existing knowledge base, and have public health relevance.  The trial design should ensure that high quality, complete data regarding the primary outcome will be collected in the most efficient manner in terms of time, resources, and burden to subjects. Secondary outcomes should be included only when they are anticipated to provide important supportive or explanatory data. The necessity of each secondary endpoint must be justified in light of cost and burden.

    Equipoise clinical research

    equipoise clinical research

    Confirmatory trials are conducted to provide a definitive answer regarding the safety and efficacy of an intervention or to compare the effectiveness of two or more interventions.  The proposed research must address a scientifically important question, provide valuable information to the existing knowledge base, and have public health relevance.  The trial design should ensure that high quality, complete data regarding the primary outcome will be collected in the most efficient manner in terms of time, resources, and burden to subjects. Secondary outcomes should be included only when they are anticipated to provide important supportive or explanatory data. The necessity of each secondary endpoint must be justified in light of cost and burden.

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