Abstract

Offshoring of clinical trials is becoming an attractive business, and strategic models to facilitate cost efficient R&D processes and clinical trials. Based on the pharmaceutical industry’s data, the financial cost associated in conducting R&D and clinical trials in most developed countries, and introduce the product in the market is about $1.2 billion (Kaitin, Harper, & Miller, 2013). This cost burden makes outsourcing a very attractive means in reducing clinical research cost. In a country such as India, there is a large naïve and diverse population available for clinical trials (Chatterjee, 2008). However, there is also increasing ethical concern especially when a clinical trial is conducted in a developing country such as India. Therefore, the objective of this application is to evaluate some of the benefits and growing ethical concerns of clinical trial outsourcing in India.

Offshoring of Clinical Trial in India

In the US and most developed countries, the cost associated with bringing a product in the market is about $1.2 billion. During the research and development (R&D) stage of a product development, 5000-10000 new chemical entities (NCEs) are screened in order to identify a potential medicinal product worthy of a clinical trial evaluation (Whitmore, 2005). The cost associated with R&D, clinical trials and regulatory fees is a costly investment which is expected to bring in a huge revenue in return. Pharmaceutical companies can stay in business only if they can recoup the cost associated with clinical research. It is estimated, only 3 out of 10 products in a company’s product pipelines generate enough revenue to keep the company running (Kaitin, Harper, & Miller, 2013). Hence, in order to stay in business, the best business model is to reduce the cost association with product development by outsourcing clinical trials. Offshoring has become one of the best way to achieve cost reduction in product development. However, the level of cost reduction is dependent on the location to which the clinical trial is outsourced. India is a country with lots of clinical trial opportunities and cost saving potentials. The country has more than 500,000 English speaking physician many who were trained in the US and UK (Jankosky, Jiang, & Farwell, 2007). Furthermore, the attractiveness in conducting clinical trials in India is that the region can sustain significant low cost budgeting such as clinical procedures, salaries, sites etc. which accounts between 30-40% of the US cost (Jankosky, Jiang, & Farwell, 2007). In the US alone, the overall clinical trial cost is between $150- $180 million dollars, which is approximately 60% more than in India (Whitmore, 2004). Obtaining a quality research data with such savings puts pharmaceutical companies in a much better position to recoup cost quickly and gain staggering profits faster.

The most important saving in conducting a clinical trial is ensuring that the clinical trial location follows and adheres to the ICH E6 (R1) guidelines. India is known to have a high level FDA approved laboratories and hospitals including large cities with better equipped research institutions (Jankosky, Jiang, & Farwell, 2007). Adhering to these standards is crucial in maintaining the tenet of justice in the Belmont report which advocates for humane respect of subjects, beneficence and justice in any clinical trials involving human subjects. Under these three principles, subjects must be treated fairly and respected under an informed consent criterion. Subjects participating in the clinical trial must also have a direct form of health benefit that outweighs the risks. Moreover, the clinical trial must be justified by representing diverse patient population based on race, gender, ethnic, etc criteria when applicable (HHS, n.d).

India’ population (over one billion) offers tremendous genetic, cultural and ethnic diversity with large naïve patient population (population that have never received drug treatment). Hence, recruitment time in this region compared to the US is quicker, a crucial advantage to sponsors seeking to recruit hundreds or thousands of subjects’ participants. In addition, many patients in India are willing to enroll in order to gain access to medical care/drugs they could not otherwise afford.

India has been emerging as a strong attractive economic region in promoting a strong culture of R&D in the health sector. However, it is very important to evaluate the vulnerability of the ethical consequences in conducting clinical trials in this part of the world to ensure that stringent quality checks and balances are met and that investigators conduct research in a manner that does not induce conflict of interest. Ethic committee independency is also a great concern due to the possibility of undue influence. The lack to maintain such high ethical standards will diminish the credibility of the research sectors, investigators or institutions conducting research, and other companies planning offshore clinical trials to this region.

References
Chatterjee, P. (2008). Clinical trials in India: Ethical concerns. Bulletin of the World Health Organization, 86(8), 581–582. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search.ebscohost. com/login.aspx?direct=true&db=a9h&AN=33717667&site=ehost-live&scope=site

Jankosky, J., Jiang, Y., & Farwell, T. (2007). Grant budgeting and negotiating in India and China. Applied Clinical Trials, 16(11), 56–62. Retrieved from http://ezp.waldenulibrary.org/login?url=http ://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=27459305&site=ehost-live&scope=site.

Health and Human Services. (n.d). The Belmont Report. Retrieved from http://www.hhs.gov/ ohrp/humansubjects/guidance/belmont.html.

Kaitin, K., Harper, B., & Miller, C. (2013). Corporate perception on medical development finance. Retrieved from https://class.waldenu.edu/webapps/portal/frameset.jsp?tabtabgroupid =21&url=%2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id%3D_2651615_1%26url%3D.

Whitemore, E. (2004). Development of FDA-Regulated Medical Products. Quality Press. Milwaukee, WI.