Controversial practices in outsourcing of clinical trials

More than half of all clinical trials are outsourced by pharmaceutical companies to subcontractors, the so-called Contract Research Organisations (CROs). As a result quality standards and the independent inspection process are jeopardised, with many negative consequences for participants in developing countries. SOMO, however, feels relatively positive about the attention recently given to the controversial practices surrounding clinical trials and CROs in various international media.

Putting Contract Research Organisations on the Radar

For the magazine Down To Earth Indian journalist Ankur Paliwal wrote the cover article Ethics on trial(opens in new window) on unethical clinical trials. In this article the author makes extensive use of the SOMO report Putting Contract Research Organisations on the Radar.

Clinical trials in India

Paul Jenkins made the documentary Body Hunters, and recently Al Jazeera English also released the documentary Outsourced: Clinical trials overseas(opens in new window) on this subject. In this documentary Zeina Awad travels to India to see what the daily practice looks like of the clinical trials for American pharmaceutical companies. She seeks an answer to the question concerning which regulatory bodies are playing a role in the clinical trials in India. Are participants aware that they are participating in a clinical trial and do these tests meet international ethical standards?

The Times of India placed an article (opens in new window) on its website attacking the CROs in Hyderabad. In July 2011 the Drug Controller General of India (DCGI) announced that violations had been found in the process of the recruitment of participants and of obtaining permissions in nine CROs.

Background of outsourcing clinical trials

Carrying out clinical trials on people in low wage countries poses serious risks. The trial subjects are often vulnerable in terms of poverty, education and illiteracy. This can give rise some serious doubts regarding to what extent participation is voluntary. Additionally the majority of clinical trials are outsourced by pharmaceutical companies to CROs who pride themselves on working faster and cheaper than the pharmaceutical companies.

This outsourcing makes the monitoring of operations difficult. Moreover, independent inspection is very limited. This becomes clear in the report Putting Contract Research Organisations on the Radar published by SOMO, the Latin-American organisation Salud y Fármacos and the Indian Centre for Studies in Ethics and Rights in early 2011.

More on this subject can be found at:

• Putting Contract Research Organisations on the Radar (SOMO and partners, 2011)
• Clinical Trials in Developing Countries: How to Protect People Against Unethical Practices? (SOMO, 2009)
• Ethics for Drug Testing in Low and Middle Income Countries (SOMO, 2008)
• A Bitter Pill (Wemos, 2007) (Dutch only)