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Introduction [edit]You can find many definitions of clinical trial as potential approaches has the theme, but predominantly the epidemiological approach and finalist (for research use drugs). From the simplest, which defines it as "scientific proof of a drug, accepted by the patient and protected by law" to the more complex; the broadest to the most restrictive, there is a wide variedad.1 We can say that the clinical trial is a prospective experimental study in which the researcher causes and controls the variables and subjects (patients, most cases) they are randomly assigned to different interventions being compared. Because it is the type of epidemiological study has minor systematic errors or biases, it is the best scientific evidence to support the efficacy of therapeutic interventions. The essential element of the test is the existence of a comparison group or control group, which allows you to test whether the new intervention (eg a new drug) is better or not existing or no intervention (placebo).
A clinical trial is initiated when a hypothesis from uncontrolled studies observational, descriptive or retrospective or preclinical studies arises. Investigations often are discovered in pre-clinical therapeutic options that have no benefit in a clinical trial. Many times medical activities whose usefulness has not been demonstrated by a clinical trial conducted, but putting it into practice is difficult, especially because of the cost and time. After being designed must be approved by a bioethics committee, patients who are part must know the objectives of the study, the risks and benefits and sign the informed and may leave the study whenever they want consent. The trial ends when they finish the timelines defined in the protocol, or when prematurely are manifestly harmful or beneficial effects on the experimental arm.
The clinical trial is the trial that has the level of evidence higher to show that the medical procedure done is best suited to scientific knowledge existing at the time, due to the study design, where the statistical variables are controlled to avoid bias. So, together with meta-analysis studies are the basis of what is known as the Evidence-Based Medicine, which is nothing more than the support of clinical practices with consistent evidence from the scientific point of view.
A clinical trial is initiated when a hypothesis from uncontrolled studies observational, descriptive or retrospective or preclinical studies arises. Investigations often are discovered in pre-clinical therapeutic options that have no benefit in a clinical trial. Many times medical activities whose usefulness has not been demonstrated by a clinical trial conducted, but putting it into practice is difficult, especially because of the cost and time. After being designed must be approved by a bioethics committee, patients who are part must know the objectives of the study, the risks and benefits and sign the informed and may leave the study whenever they want consent. The trial ends when they finish the timelines defined in the protocol, or when prematurely are manifestly harmful or beneficial effects on the experimental arm.
The clinical trial is the trial that has the level of evidence higher to show that the medical procedure done is best suited to scientific knowledge existing at the time, due to the study design, where the statistical variables are controlled to avoid bias. So, together with meta-analysis studies are the basis of what is known as the Evidence-Based Medicine, which is nothing more than the support of clinical practices with consistent evidence from the scientific point of view.
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