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THE PHARMA REVIEW (JULY - AUGUST 2012)

Clinical Trial of Drugs: The Much Hyped Ethical Concerns

Dr. Papiya Bigoniya

Introduction:
 
Clinical trials are conducted to collect safety and efficacy data of a new drug or device. The trials are performed following collection of satisfactory information regarding quality of the product, non-clinical safety, pre-clinical safety and efficacy and approval of study protocol by the concerned country health authority and ethical committee where the trial is going to take place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that compare the new product with the currently prescribed treatment. Clinical trials vary in size from a single center in one country to multicenter trials in multiple countries. The sizable cost of a full series of clinical trials is usually borne by the sponsor like pharmaceutical or biotechnology companies that develop the agents under study. Since the diversity of roles may exceed resources of the sponsor, often a clinical trial is managed by an outsourced partner such as a contract research organization (CRO).

 

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