Topic > Outsourcing of Clinical Trials to Developing Countries

This paper explores the outsourcing of clinical trials to developing countries by focusing on the current trend and providing a brief overview of clinical trials. The paper covers the main reasons for outsourcing trials in developing countries, focusing specifically on India with the ethical and scientific concerns raised in conducting clinical trials in foreign sites, shedding light on the growing career opportunities in the countries developing countries and steps for ethical conduct.Introduction: Clinical Trial Outsourcing: Global drug and medical device manufacturers based in developed countries are now focusing on developing countries to conduct their clinical trials. These players (pharmaceutical and device manufacturers) have embraced outsourcing as a core component of their business models, especially in the clinical trials space. “Outsourcing can be defined as moving or delegating a company's daily operations or business processes to an external service provider.” For example, the 20 largest companies based in the United States ("US") are now conducting a third of their clinical trials outside of the United States According to a report by the Inspector General of the Department of Health and Human Services ("DHHS ”), the number of clinical trials conducted in foreign sites increased to 6,485 in 2008 from 271 trials in 1990. This trend suggests that outsourcing of clinical services clinical trials have become one of the important aspects of business that promotes the development of safe and effective drugs and devices that arouse interest from all over the world but at the same time raise many ethical and scientific concerns. According to U.S. government publications, clinical trials registered in U.S. health authorities are being conducted in low- and middle-income groups......middle of paper......must be considered for integrity ethics and scientific research. To address these concerns, greater harmonization between developed and developing countries is needed. There should be strict compliance with rules and regulations. Furthermore, to minimize concerns, an independent ethical review of all protocols is required. Clinical trials in developing countries must meet all the ethical and scientific standards of research trials conducted in developed countries. Works Cited http://www.nejm.org/doi/full/10.1056/NEJMsb0803929#t=article http://www.offshoringtimes.com /Pages/2006/BPO_news926.htmlhttp://www.medicalprogresstoday.com/spotlight /spotlight_indarchive.php?id=1269http://globalbioethics.blogspot.com/2009/03/ethics-of-outsourcing-clinical-trials.htmlhttp ://www.lewistonvetclinic.com/ethics-concern-over-outsourcing-clinical -trial.html