With outsourcing of clinical trial projects on the increase to developing countries mainly there are many advantages seen to this. Many pharmaceutical companies look to India mainly for clinical trials because the country has a diverse population and more importantly a varied gene pool.6 Primarily India’s cheap labour force and highly-skilled English speakers have attracted many pharmaceutical companies from the USA as has therefore resulted in the emergence of numerous Indian outsourcing companies.6 According to a confederation of Indian Industry study, clinical trials in India were found to produce 70 million dollars in revenue. It is predicted that this figure will rise to 200 million dollars by 2007 and even greater to a range of 500 million to 1 billion dollars by 2010.6
Many global pharmaceuticals such as GlaxoSmithKline, Astra Zeneca, Pfizer and Eli Lily have begun to carry out clinical trial projects in India. In the case of Pfizer it has situated itself in six different cities in the northeast states of India in order to conduct clinical trials. Approximately 300 patients were trialled in on a new drug for malaria that functions by combining chloroquine and azithromycin which is an antibiotic.6 Not only is Pfizer working on this they are carrying out trials in order to find cures for osteoporosis, breast cancer as well as schizophrenia.6 Pfizer are thought to invest up to about 13 million dollars on trials up till today in India. The diagram below outlines a skeletal structure to the advantages seen when outsourcing clinical trial projects to India.7 This diagram can be associated principally with outsourcing to any country.
Diagram: Showing the advantages of outsourcing clinical research projects in India (taken from on 04/04/2007)7
The speed for drug trials in India is exceeding expectations that the Clinical Data Interchange Standards Consortium (CDISC) in the USA has enquired into setting up its own department in India.3 The CDISC is an establishment that is involved in overseeing the development of clinical research organisation standards worldwide. Even though the outsourcing of clinical research projects in developing in India is roaring, the government officials in charge of health would like to permit pharmaceuticals companies such as Pfizer to perform trials simultaneous not only in India but other countries all over the world.3 Outsourcing of clinical research projects is undoubtedly found to provide clear benefits as firstly there in “no necessity to attract as well as retain any competencies that are not core to the company.”8 Both time and money is saved on training to maintain competencies. There is also a reduction in fixed personnel as well as system costs. It is much easier to manage the workload. More importantly there is the removal of the hassle and worry associated with rigorous, documented system validation and tests as seen in the USA.8
The main danger poised with outsourcing clinical research projects is that are mainly ventured out to developing countries such as India and China. Consequently there are inherent dangers associated with this.9 The main disadvantage seen in developing countries is that the review boards that are involved in overseeing the clinical trial don’t necessarily take into consideration the ethics involved in the trial and are surprisingly found to support the welfare of both doctors and the hospitals rather than the patients.9 Ethics is a major concern and one of debate in that there is a huge spotlight on the possible mistreatment and intimidation of volunteers in the trial. In a survey that was recently published consisting of “200 health researchers globally that were commissioned by the former US national Bioethics Advisory Commission and published in the Journal of Medical Ethics” exposed that of those clinical trials that are carried out in the developed world approximately a quarter of them do not sufficiently endure a review of the ethics associated with the them.10
Other disadvantages associated with outsourcing, is that the growth in clinical trials to the developing countries could possibly be overwhelming to the regulators of the trial. With an under-funded medical system, deprived practice, poor enforcement of regulations and poverty being widespread are all indicative disadvantages.9 Most foreign trial participants in developing countries have cultural, nutritional and economic differences to an average participant from the USA.9 Therefore precautions must be taken in order to avoid skewing the data obtained from the trial. A possible solution to this could be that there is a set requirement that at least one-third of the participants in any clinical trial must be of origin from either Europe and or the USA.9
Another disadvantage with outsourcing clinical trial projects to developing countries such as China is that many individuals are not aware with clinical studies and are quite possibly mistrustful about participating; hence this slows down the recruitment process.11 One vital factor to note with the Chinese patients is the issue of racial dissimilarity in comparison to the Western world. This has a significant impact on the performance of the drug in each individual’s body. Also the genetic variation observed across the Chinese population has up till today been understood and characterised. This in retrospect to India poses a disadvantage as the Indian share similar racial characteristics to the western world both in Europe and USA.11
Outsourcing clinical research projects primarily to the third world with out a doubt does pose risks and has disadvantages but it is more advantageous. As even if seen at one level whereby Indian patients are being used as guinea pigs they are from a land of poverty.11 The participants are free to leave the trial at any stage and ultimately they are not only helping aid research they are obtaining free treatment. The companies that invest on outsourcing also provide improved facilities at the research centres along with beds for the patients.10 This consequently is enhancing the healthcare system in the country. The majority of the population approximately over 1 billion who is living in poverty will never have enough healthcare facilities whatever the means.12 The drug development process is a lengthy process and great efforts are made by companies to get drugs on the market but it is estimated only 15 % which enter this process actually make it.13 For that reason outsourcing is ideal not only in providing resources for that country but more importantly the treatments that are discovered and developed are vital because they have aided to save lives, and improve the quality of life for millions worldwide.
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- Unit PHSB3076 – Clinical Research (Liverpool John Moores University), Dr V. Anderson, Lecture notes on Outsourcing Clinical Research Projects (2007).
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Ignazio Di Giovanna, Gareth Hayes, Principles of clinical research (2001), 1st Edition, and Institute of clinical research, Chapter 22 on: Outsourcing clinical research projects, Pg 485.
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