PLoS Medicine
(Accessed 16 June 2012)
http://www.plosmedicine.org/article/browse.action?field=date

Clinical Trials Have Gone Global: Is This a Good Thing?
Trudie Lang, Sisira Siribaddana
Essay, published 12 Jun 2012
doi:10.1371/journal.pmed.1001228

Summary Points
– Clinical trials are conducted across the globe for perfectly good reasons. This is positive because populations in developing countries are under-represented in research.

– Research sites in developing countries benefit from working with externally sponsored clinical trials because they benefit from increased capacity development and investment.

– Locally led research is becoming harder to undertake in developing countries because of complex trial regulations and administrative burdens. There should be a balance between local and externally led trials.

– There is a need for more trials that compare different approaches to managing disease and health issues. This is especially true in low-income settings where simple interventions could make significant improvements to health outcomes if there was evidence to support implementation.

– Clinical trials operations should be specific to the risk and complexity of each trial and not governed by one-size-fits-all requirements of sponsors and their contracted organisations. Overly burdening trials with too-rigorous requirements is pushing up costs and putting off investigators to undertake research.

– Trials in low-income settings need to contribute to clinical trial methodology research efforts.