International outsourcing of medical research by high-income countries: changes from 1995 to 2005.

BACKGROUND

Medical research outsourcing provides a financial benefit to those conducting research and financial incentives to the developing countries hosting the research. Little is known about how frequently outsourcing occurs or the type of research that is outsourced.

METHODS

To document changes in medical research outsourcing over a 10-year period, we conducted a cross-sectional comparison of 3 medical journals: Lancet, The New England Journal of Medicine, and JAMA: The Journal of the American Medical Association in the last 6 months of 1995 and 2005. The main outcome measure was the 10-year change in proportion of studies including patients from low-income countries.

FINDINGS

We reviewed 598 articles. During the 10-year period, the proportion of first authors from low-income countries increased from 3% to 6% (P = 0.21), whereas studies with participants from low-income countries increased from 8% to 22% (P = < 0.001). In 2005, compared with studies conducted exclusively in high-income countries, those including participants from low-income countries were more likely to be randomized trials (55% vs 35%, P = 0.004), to study medications (65% vs 34%, P < 0.001), to be funded by pharmaceutical companies (33% vs 21%, P = 0.05), and to involve pediatric populations (29% vs 8%, P < 0.001).

INTERPRETATION

Outsourcing of medical research seems to be increasing. Additional studies are required to know if subjects from low-income countries are being adequately protected.