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Offshoring
Country selection: China
China, undeniably, represents one of the best markets to perform a clinical trial. It is home to the largest global urban population, and provides an extensive patient pool as well as a vast network of hospitals. The country boasts of nearly 1.4 million physicians/doctors and over 1 million technicians and nurses. Low medical staff salaries partly contribute to lowering clinical trial costs in China by around 50% of the cost in America. Pharmaceutical firms find China an attractive option; it is projected by some that, by the year 2020, China might overtake America as the largest global market (CDE and CFDA, 2013). The nation is quickly being recognized as an attractive location for carrying out clinical trials by providing sponsors with multiple benefits, some of which are: 1) China is the most populous Asian country; and 2) It can provide pharmaceutical companies with a large share of subjects diagnosed with major diseases, that are of interest to pharmaceutical firms. Other advantages include: highly skilled investigators, strong infrastructure, low costs, superior patient recruitment as well as adherence rates, and firm ethical support (Puppalwar, Mourya, Kadhe & Mane, 2015). One fact to be noted is that delay in regulatory timelines offers unique advantage to trials carried out in China: investigators normally devote this additional time to improving the process of selection, thereby warranting quick...
While only CFDA (China Food and Drug Administration)-designated health centers are authorized to conduct trials, such institutions' principal investigators typically have broad experience working with Western firms, thus making the process smoother (Soni & Singh, 2013). The regulatory process of China is an effectively -controlled and documented process conducted strictly in accordance with regional regulations, ICH (International Conference on Harmonization), and GCP (good clinical practice). In an effort towards revitalization, the Chinese regulatory body renamed itself, in 2013, as the CFDA. Its operations are similar to that of the American FDA, and it tasks the CDE (Center for Drug Evaluation) with reviewing clinical trial applications (CDE and CFDA, 2013).
Of late, China has grown into a key location for clinical trials, as it is characterized by an exceptional combination of a huge population (more than 1.4 million individuals) and low costs. China's population is both genetically diverse when compared to Western countries, and is afflicted with a vast pool of diverse chronic and acute illnesses. The…
References
Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), (2013). Program to standardize clinical trial data management. translation: Thomson Reuters.
Puppalwar, G., Mourya, M., Kadhe, G. & Mane, A. (2015).Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors. Journal of Clinical Trials, 7, 23-34.
Soni, U. & Singh, M. (2013). Clinical Trials Outsourcing: Good or Bad? Drug Des 2: 104. doi:10.4172/2169-0138.1000104
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