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Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.
Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results. [22] Trials can be quite costly, depending on a number of factors.
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For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
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A descriptor which is applied to any substance or process which is being investigated for clinical use but either has not commenced, or has not completed, clinical trials. Examples: candidate vaccine, candidate formulation. Case report A detailed report of the diagnosis, treatment, and follow-up of an individual patient.
Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials; Epidemiology – the study of factors affecting the health and illness of populations
Whereas randomized clinical trials usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation, the case report can detail many different aspects of the patient's medical situation (e.g. patient history, physical examination, diagnosis, psychosocial aspects, follow up). [8]