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Discuss the sources of variation in clinical tests highlighting the differences between clinical and analytical variations
Discuss the sources of variation in clinical tests highlighting the differences between clinical and analytical variations
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Answer: Clinical trials is a program in research for evaluating the efficiency, efficacy of a new drug, medical device or treatment with the patient. Finding new and improved methods of treatments, prevention of diseases, screening of various products or drugs is the purpose of clinical trials. There are various variations in clinical testing that also can lead to alteration in the results as well. Effect due to both analytical and biological variation is observed, when the variations exceed a level, significant changes in the condition of the patient can be observed.
1. Inability to Follow Proper Laboratory Procedures—Unexpected Delay in Sample ProcessingVariations are like, the people do not follow proper laboratory procedures and there is often delay in the sample processing. The delaying of the test results in variations.
2. Test Interference: There are various parameters that result in test interference like altered conditions.
3. Instrument Malfunction/Operator Error: There are times when instruments do not work properly, malfunction of instruments is there and hence resulting in operation error.
4. Clinical Pathology Staffing Qualifications: The qualifications of the staff dealing with clinical research that could lead to disbalance in the appropriate handling procedures.
The difference between analytical and clinical variations is that analytical variations are chemical variation, variation in handling and tests, results. The clinical variations include variations of overuse, waste of healthcare variations.
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