The Ethics of Clinical Trial Clinical trial is a systematic research study of drug, diagnostic tool, or intervention, done on human being, with the objective of determining its safety and efficacy. The main purpose of clinical trial is to provide better and improved treatment in patient care. Clinical trial is conducted to know whether the new treatment is better than the existing treatments or whether the doses have any side effect, if yes, is it less than the existing system. Clinical trial has to be conducted only after the approval of the protocol, that are approved by a registered Institutional ethics committee. Ethics committee strictly monitors, whether patients safety, right, well being and confidentiality is properly maintained and documented and can stop the study if breached, at any time. Clinical trial can only be started after the permission of the regulatory authority. Regulatory authority gives approval of the study that are approved in prior by Institutional ethics committee. The clinical study is designed with the strength of informations got from the pre-clinical studies, usually done in laboratory animals. Clinical trials are usually done in 4 phases namely, Phase I – Clinical pharmacology (usually on healthy volunteers), Phase II – Therapeutic exploratory trials (On limited number of patients), Phase III – Therapeutic confirmatory trials (on large number of patients) and phase IV – post marketing surveillance. All the drug that are coming to the market should pass through all these procedure, and this gives a biggest financial burden to the pharmaceutical company. #Health #MedicalNews #HealthCareArticles #HealthUpdates medibiztv
Posted on: Mon, 19 Jan 2015 06:25:55 +0000
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