Putting Contract Research Organisations on the Radar

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. 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? 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.