Clinical trial outsourcing is a boon to the western drug companies since developing countries not only ensure cheaper trial costs but also offer crucial savings on time to market. Conduct of clinical trials in developing nations does require some improvement in terms of regulatory aspects but they undeniably offer a lot of advantages, which have attracted the pharmaceutical industry from the west to outsource their clinical trials to developing nations. China and India continue to attract a lot of global attention and deals.
Introduction:
A Global Drift In The Clinical Research Industry:
In the past clinical research was only conducted in developed countries like the US, but now the pharmaceutical industry is focusing on its interests towards developing nations such as India, China, Latin America etc. Cost effectiveness and the availability of a large and diverse patient pool are few advantages that are making developing countries a new global destination for clinical research. Globalization of clinical trials will bring global benefits, enabling pharmaceutical companies to investigate new drugs on a larger patient population quickly and effectively. Also, clinical trials would bring resources and expertise to the developing and poor nations giving trial participants an access to treatment that they would otherwise be denied (Gilland T., 2010). India is a microcosm representative of the whole world in its diversity due to the presence of large and genetically diverse population.
The outsourcing of clinical trials to the developing countries has gained momentum only a decade back. Since the drug patent lasts for only 20 years of which the first seven to eight years are dedicated to the several rounds of human clinical trials, it leaves little time for the pharmaceutical company to market the new drug/device and make a good profit out of it. Thus, to speed up clinical trials, the industry needs to recruit a large number of subjects quickly in short duration, which is sometimes not possible in developed nations. Thus, the pharmaceutical industry expedites this process by outsourcing clinical trials to developing nations where patient population is readily available. It not only saves cost and time but also strengthens the companies drug claims by providing drug safety and efficacy data from a variety of ethnic backgrounds.
Scraping- Need For Regulations:
Extending clinical research to developing countries in order to bypass the strict and prohibitory ethical regulations is analogous to a common job outsourcing strategy, through which companies exploit cheap labor of the populous poor and developing countries to maximize their revenues. The well being of trial subjects should be considered the utmost priority over the interests of science and society. The treatment diffusion rate and penetration rates are typically faster in developed countries, where the pharmaceutical market predominates compared the developing regions. This certainly raises a question of ethical concern: What happens to the patients in developing countries, once the study is completed and trial medications are withdrawn? The regulatory infrastructures and independent ethics committees that can minimize the exploitation risk are less established, less financially supported and less effective in the developing countries. (Emanuel E J et al., 2003)
The clinical trials that are no longer accepted by western or developed nation’s ethics committees are easily approved by the local ethics committees of developing nations like India, China, Latin America, Russia etc. Once the trial is officially approved by the ethics committee, there are no obstacles for including the trial in the technical dossier of a marketing application by the pharmaceutical industry.
Ironically, the ethical principles that are of utmost importance for developing countries to conduct a clinical trial, as stated in Declaration of Helsinki, are continuously ignored and neglected by drug development companies and the regulatory authorities. (Schipper I., 2009)
More than a quarter of clinical trials carried out in developing countries do not undergo any kind of ethical review. This gap highlights the urgent need to conduct ethical review in the developing nations by developing ethical guidelines and code of conduct for all researchers, to ensure that the trial participants are not exploited, especially when the studies/trials are funded by companies or research funding agencies based in the wealthy nations. (Jain R K., 2004)
Current Scenario in Developing Countries:
Clinical trials in developing countries are exploding and now becoming a major business source. Around 20-30% of the global clinical trials are being conducted in the developing countries. (Bhatt A., 2004)
Outsourcing of clinical trials for the development and global studies of new drugs are widely accepted in the pharma industry due to its cost effectiveness and uncertainty. Availability of large treatment naïve population, well- trained medical professionals, technical skills, adoption /amendment/implementation of rules/laws by regulatory authorities, large English speaking population and comparatively low cost have made India an attractive destination for conducting global clinical trials. (Maiti R et al., 2007)
Future Outlook of Conducting Clinical Trials in Developing Nations:
With stringent and strict regulations, elaborate safety and compensation requirements, slow and expensive subject recruitment, conducting a clinical study in Western countries has become very difficult. Consequently, many pharma and research based companies are now outsourcing some of the clinical trials to developing countries like China, India, Thailand etc. The main advantage of conducting clinical trials in developing nations are its less stringent laws and regulations, cheap labor and low infrastructure costs, which reduce the expenditure cost for clinical trials by 60%. (Nundy S et al., 2005 )
Clinical research offers value and value-added infrastructural incentives to the developing countries. The recruitment rate is greatly accelerated which leads to shorter study duration due to the availability of large patient pool in developing nations. Thus attracting a large number of pharma companies to outsource clinical trials.
Collaborative partnerships among the researchers and the sponsors in developed countries and researchers, policy makers, and communities in developing countries helps in minimizing the exploitation risk by ensuring that the regulatory bodies in developing countries determine whether the research/ trial is acceptable and will benefit the community’s health problems. (Emanuel E J et al., 2003)
Exploitation of Trial Participants in Developing Countries:
Human behaviour leads to the global phenomenon of scientific misconduct. Misconduct of clinical trials in developing countries have been dogged by controversy over the ethical procedures involved in approving the trials funded by wide range of pharmaceutical companies and research institutions. The vulnerability caused by poverty and illiteracy in developing countries make it difficult to ensure patient safety as they do not fully understand the risks and consequences of the trial in which they are participating. Lack of resources in poor countries generates obstacles in achieving appropriate levels of regulatory checks and ethical oversights. (Gilland T., 2010). Trial participants in developing countries are sometimes treated as “Guinea Pigs” by the pharmaceutical companies outsourcing clinical trials to developed nations.
Another important condition to protect the clinical trial subjects in the developing countries is the development of transparency on the existence of trials, study protocols and their results. Currently, lack of information about the ongoing clinical trials in developing countries is one of the major obstacles. Transparency urges the sponsor or the investigator to carry out the research ethically, which can be done by developing a database that is easily accessible to the public. (Schipper I., 2009)
India the most preferred destination for Clinical Trials:
India is now becoming one of the most favourable destinations for conducting global clinical trials. The success is entirely dependent on the availability of sufficient, skilled personnel to work on clinical trials for the global sponsors. Also, India provides benefits like large genetically diverse patient pool, highly educated medical professionals, wide spectrum of disease, low cost, favourable economic and intellectual property environment and well established ethical regulatory guidelines. (Julka P K., 2007). India’s generic firms are gearing up to play an important role in the evolving biogenerics market, thus, is well poised to become a hub for processing and managing clinical data.
Conclusion:
Clinical trial market in developing nations is eventually booming with pharmaceutical companies from the Western world offering lucrative offers for the conduct of clinical trial. Though outsourcing clinical trials offers many advantages to the pharmaceutical companies like large patient pool, drug naive population, rapid enrolment, excellent data quality, low cost, highly trained medical professionals etc., certain problems also exist such as poor transport and communication system, lesser monitoring frequency and set-up time, poor ethical supervision of trials, limited access to specialized equipments in some trials etc. Development of better regulations to oversee the conduct of clinical trials will definitely bring the level of these trials to meet the global standards.
Grant funding/support: None declared
Financial disclosures: None declared
References:
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2. Emanuel E J, Wendler D, Kellin J, Grady C. 2003. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. Oxford Journals of Medicine- Journal of Infectious Disease; 189(5): pp 930-937
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Author: Neha Gupta, CRA, Clinexa Life Sciences
