Outsourcing Of Clinical Trials Research Articles

Unethical Human Experimentation in Developing Countries and International Criminal Law: Old Wine in New Bottles?

Since Nuremberg, the ethics of scientific research involving human beings has been for decades the source of concern and controversy. Profit-driven experimentation sponsored by the pharmaceutical industry has progressively migrated to the South, turning into a widespread phenomenon imbued with ethical challenges and dilemmas. The protection of vulnerable communities from the risks of unethical behaviour and exploitation, often associated with the outsourcing of clinical trials in developing countries, calls for respect of internationally agreed standards. This Article argues that massive experiments conducted in disregard of universal bioethical principles and human rights may amount to crimes against humanity under international criminal law. It also suggests that, in such cases, the International Criminal Court would have jurisdiction over a broad range of liable individuals, including public officials of host and sponsoring States, physicians and researchers acting in their private capacity, as well as officers and directors of pharmaceutical corporations.

Fast, cheap, and out of control? Speculations and ethical concerns in the conduct of outsourced clinical trials in India

The globalization of biopharmaceutical clinical trials and their offshore outsourcing, from the West to low and middle-income countries, has come under increasing scrutiny from academic scholars, practitioners, regulatory agencies and the media. This article reports the results of a study conducted in Bangalore and Hyderabad between 2007 and 2009, to elicit the perspectives of stakeholders, concerning media representations of their work and the ethical issues that emanate from their engagement in the clinical trials enterprise. In acknowledging the inherently problematic nature of the outsourcing of clinical trials to low income countries, I argue that the practice of not prioritizing research on diseases that are most prevalent among communities, from which subjects are recruited, demands a coordinated and sustained critique. I propose that the critical discourse on the outsourcing of clinical trials should not only emphasize the perils of this practice, but also address some broader issues of equity and distributive justice that determine people's access to basic health care in low income countries. Close attention to the specific context of clinical trials in an increasingly neoliberal medical and health environment in emerging economies such as India can provide critical insights into the on-the-ground complexities and challenges of outsourced global clinical trials.

Putting Contract Research Organisations on the Radar: An Exploratory Study on Outsourcing of Clinical Trials by Pharmaceutical Companies To Contract Research Organisations in Non-Traditional Trial Regions

It is a trend for pharmaceutical companies to contract third parties to conduct their clinical trials in order to test their drugs. This trend is referred to as ‘outsourcing’, and the companies that carry out the work are called ‘contract research organisations’ (CROs). In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low- and middle-income countries. This trend is called ‘offshoring’. It is widely agreed that the offshoring of clinical trials to these regions should be scrutinised from an ethical perspective because of the vulnerability of the trial population. What happens when offshoring is combined with outsourcing? Do additional ethical risks arise when clinical trials are contracted out? Virtually all pharmaceutical companies publicly declare that they test their drugs in accordance with the highest ethical guidelines, such as the Declaration of Helsinki. But how do pharmaceutical companies safeguard their commitments when they outsource clinical trial activities to CROs in poor regions? These are the central questions that are addressed in this report. The report is based on research conducted in India, Argentina, Brazil and Peru, and combined with interviews with pharmaceutical companies and clinical trial experts. The research experiences demonstrate that the pharmaceutical sector is generally not transparent, which hinders the definitive answering of the research questions. Nevertheless, the secondary and interview data collected in India, Argentina, Brazil and Peru provides some valuable insights into the way the CRO sector is developing in these countries. Furthermore, the report demonstrates that pharmaceutical companies have elaborate systems in place to manage their supply chain responsibility, although their functioning can not be independently verified. In addition, experts, authorities and clinical trial practitioners in the selected non-traditional trial regions still expressed grave concerns about the implementation of clinical trials in these countries.

Addressing issues affecting clinical trials in Brazil

There are several factors that play a key role in the growth of clinical research specific to Brazil. These include a large, diverse, rapidly growing population much of which is treatment-naive, shortened approval times, improved GCP compliance, and an emergence of diseases predominant in developed countries. Successful patient enrolment and retention rates, and proximity to Western biopharmaceutical companies are additional factors. Due to the fact that the Brazilian population exhibits great racial and ethnic diversity, as well as differences in economic and educational backgrounds, there are significant hurdles that foreign sponsors must consider. These include linguistic and cultural barriers, as well as other socio-economic factors such as poverty and illiteracy. Successful outsourcing of clinical trials to Brazil therefore involves an understanding of these factors, and how they affect clinical research.

Experimental Labour—Offshoring Clinical Trials to China

The State Food and Drug Administration of China has reported a dramatic increase in multicentre, multinational clinical trials over the past several years. This is in keeping with a growing trend towards the off-shore outsourcing of clinical trials from North America and Western Europe to ‘nontraditional locations’ such as Eastern Europe, China, and India. Within China, the post-socialist reform of health care, internal divisions of labour and the politicization of the healthcare system have all created the conditions under which contract clinical trial work is becoming an imperative both for hospitals and the growing number of working uninsured. The paper brings together a critical insight into current theories of bioeconomic innovation with new political economies of informal labour and offshoring. It argues that the clinical trial phase in the production of bioeconomic value is routinely overlooked in scholarly accounts but is key to understanding the speculative overinvestment and translational difficulties of the pharmaceutical industries today. As a way of reformulating the problem, the paper suggests that human subject experimentation would be more fruitfully reconfigured as a form of labour—experimental or clinical labour. The research hospital clinic therefore emerges as an export labour zone in ‘experimental body work.’

DRUG FIRM OUTSOURCING: HOT FIELD FOR CHEMISTS

Pharmaceutical companies are under increasing pressure to shorten the time required to get a drug to market. One tactic is the formation of partnerships with other companies, or outsourcing. Outsourcing has progressively moved to earlier stages of the development timeline. With the outsourcing of clinical trials, it became established that drug companies were willing to outsource certain tasks, if and when there were appropriate outsourcing options, says Robert J. Olan, an analyst at Chase H&Q in New York City. He describes such activities as chemistry and biological screening as crown jewels that the pharmaceutical industry was originally reluctant to outsource. However, that has changed. Olan asserts that pharmaceutical companies are willing to let outside companies perform discovery tasks if those companies can work better, faster, and cheaper and if the client's data can remain proprietary. Drug discovery has evolved such that pharmaceutical companies are trying to ensure that only viable comp...