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    Clinical Trials in India

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    CLINICAL TRIALS Clinical Trials in India are regulated under the Central Drugs Standard Control Organization (CDSCO) and Drugs and Cosmetics Act, 1940, respectively. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials as a “systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetic) and/or adverse effects with the objective of determining safety

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    The gold standard for a clinical trial design is the inclusion of a control. A control could be a placebo, active or no treatment. Clinicians use controls in order to give more power for their studies. A placebo control is a vehicle without the active ingredient. The main purpose of using a placebo in clinical trials is to differentiate the background noise from the actual effect of the treatment drug. Regulatory agencies prefer or favor trials that use controls such as placebo since the data obtained

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    Clinical trials

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    Introduction Clinical trial is biomedical or health related research studies in human being that follow a pre-defined protocol. Research is an activity designed to test a hypothesis that helps in concluding and developing knowledge. It is a protocol that has an objectives and procedures to reach those objectives (1). There are two types of clinical studies. One is interventional studies in which the research subjects are assigned by the investigator to a treatment or other intervention, and their

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    Introduction: Clinical trials are studies made by assigning human participants either individually or by groups to evaluate the outcomes of the new treatment and how it does effect humans in terms of health. The purposes of clinical trials are mainly for treatment registration, and availability for public use. Clinical trials are not limited to drug use only, but also they include surgical procedures, radiology procedure, etc. Clinical trials have been used for a long time to test treatments. It

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    Clinical drug trials are tests on drugs to find out if the outcome is a cure to the disease or not. In other words, clinical drug trials are done to figure out the effectiveness of the drug. Clinical drug trials are ethical because the scientists are trying to find hope and cures to diseases that may be taking over a person’s life. Chase, who has fragile X syndrome, showed signs that the drug he took in a clinical drug trial, minocycline, was working when he began to develop the abilities to understand

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    Introduction Clinical trial is a gateway to become proved practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials require that prospective, carefully selected subjects and endpoints

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    explores outsourcing of clinical trials to developing countries focusing on current trend and providing brief overview of the clinical trials. The paper covers major reasons for outsourcing of trials to developing countries especially focusing on India with ethical and scientific concerns raised in conduct of clinical trials at foreign sites, throwing a light on growing career opportunities in developing countries and steps for ethical conduct. Introduction: Clinical Trial Outsourcing: Global Drug

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    marketing Surveillance in Clinical Trial Clinical trials containing new drugs are categorized into essential four phases (1). The drug development procedures are usually performed through the all phases over several years (1). The drug will be approved for use in the general population, if it successfully exceeds through the first three phases; I, II, and III. The fourth phase -IV- is called Post marketing Surveillance and/or Post approval studies (2). Postmarketing Surveillance Trial provides the safety

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    Introduction The cost associated with conducting clinical trials is one area that many institutions fail to consider. The “hidden costs” as I like to call them or administrative fees incurred by institutions for maintaining non-enrolling clinical trials is just one example. At a time when costs are rising in practically every area of running clinical trials, it is absolutely necessary to have a budget that adequately meets the financial needs of a study regardless if the study is enrolling patients

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    The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable

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