blog




  • Essay / 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 to developing countries, with a particular focus on India, with ethical and scientific concerns raised when conducting clinical trials at foreign sites, highlighting growing career opportunities in developing countries and steps to ethical conduct. 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 adopted outsourcing as a core part of their business models, particularly in the area of ​​clinical trials. “Outsourcing can be defined as the transfer or delegation of a company's daily operations or business processes to an external service provider. » For example, 20 largest US-based companies now conduct a third of their clinical trials outside the country. United States According to a report from the Inspector General of the Department of Health and Human Services (“DHHS”), the number of clinical trials conducted at foreign sites increased to 6,485 in 2008, compared to 271 trials in 1990 This trend suggests that outsourcing of clinical activities Clinical trials have become one of the important aspects of business promoting the development of safe and effective drugs and devices that attract interest worldwide, but which raise concerns at the same time. time of many ethical and scientific concerns. According to U.S. government publications, clinical trials registered with U.S. health authorities are conducted in middle- and low-income countries...... middle of paper ...... should be considered for the ethical and scientific integrity of research. Increased harmonization between developed and developing countries is needed to address these concerns. Rules and regulations must be strictly followed. Furthermore, to minimize concerns, independent ethical review of all protocols is necessary. Clinical trials in developing countries must meet all ethical and scientific standards of research trials conducted in developed countries. /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 http://www.lewistonvetclinic.com/ethics-concern-over-outsourcing-clinical-trial.html