Clinical Trial Outsourcing:
Global Drug and Medical Device makers based in developed countries are now focusing on developing countries to carry out their clinical trials. These players (pharmaceutical and device makers) have embraced outsourcing as a core component of their business models especially in realm of clinical trials. “Outsourcing may be defined as shifting or delegating a company’s day to day operations or business process to an external service provider.”
For instance, 20 largest United States (“U.S.”) based companies are now conducting one third of their clinical trials outside the U.S. According to a report from the inspector general of Department of Health and Human Services (“DHHS”) the number of clinical trials conducted at foreign sites has increased to 6,485 in 2008 from 271 trials in 1990. This trend suggests that the outsourcing of clinical trials has become one of important aspects of business fostering development of safe and effective drugs and devices that are interest of through out the world but at same time raising many ethical and scientific concerns.
According to U.S. government publications, clinical trials that are registered with U.S health authorities are being conducted in middle and low income co...
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...s must be taken into consideration for ethical and scientific integrity of research. Increased harmonization among developed and developing countries is needed to address these concerns. There should be strict compliance with rules and regulations. Further to minimize concerns independent ethical review of all the protocols is necessary. Clinical trials in developing countries must meet all ethical and scientific standards of research trials conducted in developed countries.
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