Published: 21.05.2018 02:09

Clinical studies in medical biochemistry 3rd edition pdf

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Clinical trials on treatment using a combination of Traditional

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It is important for the performance of a clinical trial that it should be carefully planned and that the exact clinical details and methods should be specified in the study protocol ( 68 ). It is, however, also important that the implementation of the study according to the protocol, as well as data collection, must be monitored. For a first class study, data quality must be ensured by double data entry, programming plausibility tests, and evaluation by a biometrician. International recommendations for the reporting of randomized clinical studies can be found in the CONSORT statement (Consolidated Standards of Reporting Trials, - ) ( 69 ). Many journals make this an essential condition for publication.

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Important and justified ethical considerations may restrict studies with optimal scientific and statistical features. A randomized intervention study under strictly controlled conditions of the effect of exposure to harmful factors (such as smoking, radiation, or a fatty diet) is not possible and not permissible for ethical reasons. Observational studies are a possible alternative to interventional studies, even though observational studies are less reliable and less easy to control ( 67 ).

The authors declare that there is no conflict of interest in the sense of the International Committee of Medical Journal Editors.

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The quality, reliability and possibility of publishing a study are decisively influenced by the selection of a proper study design. The study type is a component of the study design (see the article Study Design in Medical Research ) and must be specified before the study starts. The study type is determined by the question to be answered and decides how useful a scientific study is and how well it can be interpreted. If the wrong study type has been selected, this cannot be rectified once the study has started.