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Abstract

BENEFITS AND RISKS IN CONDUCTING OF CLINICAL TRIALS OF DRUGS IN HUMAN MEDICINE

Albena Zlatareva*

ABSTRACT

The aim of this study is to make an analysis based on the different literature sources about the benefits and risks of conducting clinical trials in human medicine. A clinical trial is defined as a controlled trial in humans of new drugs, devices, therapy or diagnosis, or comparisons of currently approved drugs, devices, therapy or diagnosis, to assess the safety, efficacy, benefits, costs, side effects, and / or results. Such studies can be conducted within the frame of industry to developed protocol (referred to as a "sponsor-initiated clinical trial") or protocol developed by the researcher ("investigator initiated clinical trial"). These studies most often carried out in connection with the new drug of phases I, II, III or IV, although they may be designed for the sole purpose to collect and analyze the data for the approved drugs or devices, in order to contribute to the medical knowledge for the treatment of a disease or medical condition. Clinical trials are usually financed by pharmaceutical companies and are an important part of the safety and efficacy of the drug or device to obtain approval from the institutions, with the final goal of selling the product on the market. Any such process is associated with benefits and risks to this conclusion reach authors working in the field, as the most common benefits are: obtaining access to new treatments that are not yet available to the public, receiving expert medical care and the patient has an active role in their own health care, but also helped others with similar diseasesby contributing to medical research. Last but not least is the economic benefit for society and the individual patient. Risks, according to the authors, there may be unpleasant, serious or even life-threatening side effects of treatment, processing data is not always effective, the study may require a lot of time traveling to the place of the analysis, patients may need and hospital stay or more complex application of the test product, which would harm him via normal lifestyle. Costs not covered by public health insurance, at least not in full also helped others with similar diseasesby contributing to medical research.

Keywords: Clinical trial, benefit, risk, medicine.


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