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European Pharmaceutical Contractor
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Clinical trials are both a major financial investment and a risk for pharmaceutical and biotechnology companies. The Boston Consulting Group estimated that when interest and drug failure costs are taken into consideration, the cost of developing a new drug could be as high as US$500 million (1). This cost is primarily driven by the increasingly stringent requirement for companies to satisfy relevant regulatory authorities that the drug being developed is both effective and safe for use in the patient populations for whom it is intended. Clinical trials undertaken to provide this reassurance can vary from single centre studies right up to the multi-centre, global studies with thousands of patients undergoing treatment for several years. This increased tendency for long-term global trials is driven by numerous aspects, including the following:
The need to enrol appropriately 'treatment-naive' patients in a heavily medicalised world
The need to push for subtle improvements over existing therapy
The need to encompass 'outcomes' issues and pharmacoeconomic aspects
The need to check for rare interactions and adverse events
The need to provide data involving populations/countries included in launch plans
The need to provide persuasive evidence to authorities no longer confined to purely medical assessment
The overall increased regulatory hurdles have resulted in a drug development time of 15 years being considered average - from the time of a new chemical entity's discovery in the laboratory to the eventual marketing approval and granting of a product licence (2).
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BioPh India
1-3 December 2010, Mumbai, India
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