China as an advantageous location for pharmaceutical clinical trials

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 recruitment of patients, with rates that are ahead of targets.

Challenges

In spite of all the aforementioned advantages, China poses some challenges as well when it comes to performance of clinical trials. Bureaucracy and stringent governmental regulations pose continuous risks for firms. For instance, gaining CFDA approval for conducting a trial may take anywhere between 9 and 12 months. Further, firms need to acquire drug import licenses for all shipments entering the nation, instead of one for every drug type. China's national infrastructure is weak and intellectual property rights in the nation are irregularly enforced. Language and cultural differences add to costs, and may hamper the clinical trial process. For instance, Chinese researchers continue recording data in their native language, which increases translation costs and further delays the process (Puppalwar et al., 2015).

Weak measures for protecting intellectual property, coupled with clinical trial taxes and other forms of Chinese governmental intervention are major barriers to clinical trials. Patient recruitment ethics is a concern, as well. As doctors may earn ten times more through the performance of clinical trials, a primary fear exists that some might neglect to ensure patients know of crucial risk factors. Firms that perform trials in the country must establish well-defined procedures, whilst closely monitoring patient recruitment, for ensuring adherence to international ethics standards (Soni & Singh, 2013).

The tenet of justice included under the Belmont Report, which requires equal respect to be given to all, is sometimes not observed thoroughly in China, particularly when it comes to the urban and rural poor. Despite researchers obtaining participants' informed consent, researcher's interests may overshadow respect for individuals, during implementation. This is also a violation of the Report's beneficence tenet, which demands that participants' interests be considered (Puppalwar et al., 2015).