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Clinical Trial Outsourcing
Contract Issues in the Outsourcing of Clinical Trials
The increasingly common practice of outsourcing clinical trials for pharmaceutical research and development is fraught with legal and ethical complications, especially as much of the outsourcing finds these clinical trials taking place in underdeveloped countries that lack infrastructure and appropriate civil and social oversight. In a scenario such as the one described, where an unequal partnership shares certain rights to the intellectual property and the physical substance that will be undergoing the clinical trial, new wrinkles in the responsibilities of parties and the necessities of established contracts arise. Looking to current research in the area can help determine the services and contract constraints that will be required to create an ethical and effective clinical trial that serves the immediate research and development needs of the pharmaceutical partnership hiring a central African...
A variety of medical and medical support services, from the recruitment of participants to initial examination to ongoing testing during the trial and many others, will be required as the fundamental operation of the trial (Rettig, 2000). There are also many accounting and legal services that will need to be procured, ensuring that the clinical trial meets with all relevant governmental criteria for United States/European standards and with the laws in place in the country selected for the trial, such that an entire industry of contract research has emerged (Sen & Shiel, 2006; Petryna, 2007; Rettig, 2000; Shuchman, 2007). These firms can ensure that all necessary services are adequately procured.
Clearly, contracting with a contract research organization to handle further contracting would be…
References
Petryna R. (2007). Clinical Trials Offshored: On Private Sector Science and Public Health. BioSocieties 2:21-40.
Rettig, R. (2000). The industrialization of clinical research. Health Affairs 19(2): 129-46.
Shuchman, M. (2007). Commercializing Clinical Trials -- Risks and Benefits of the CRO Boom. New England Journal of Medicine 357: 1365-8.
Sen, F. & Shiel, M. (2006). From business process outsourcing (BPO) to knowledge process outsourcing (KPO): Some issues. Human Systems Management25(2): 145-55.
Outsourcing Firms outsourcing clinical research for a number of different reasons. The theory of comparative advantage underlies CRO, as firms in other countries might be able to do the research more effectively, or more efficiently. Often, CRO done in order to save money, as is particularly the case with India. In other instances, the outsourcing is done to firms that have developed particular specialties in research (Piachaud, 2002). In India, firms are
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