Conducting more clinical trials in developing countries is of benefit because these populations are underrepresented in research, but doing trials in resource poor settings has many challenges. Research sites in developing countries benefit from working with externally sponsored clinical trials including increased capacity development and investment, but locally led research is also challenged by complex trial regulations and administrative burdens. These are some of the conclusions of an Essay by Trudie Lang and Sisira Siribaddana published in this week's PLoS Medicine.
The authors argue that there is a need for more trials that compare different approaches to health and disease, because in low-income settings simple interventions can bring significant improvements to health outcomes if there is evidence to support implementation. They also say that 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 organizations, which pushes up costs and puts investigators off undertaking trials in low-income settings.
The authors conclude: "the globalisation of clinical trials should not be about running inexpensive trial sites to benefit distant people, but should focus on bringing research to populations who have previously been under-represented in clinical trials, and enabling these same communities the benefits resulting from new drugs, vaccines, and improvements in managing health."
Funding: No specific funding was received for writing this article.
Competing Interests: SS has been funded by the Wellcome Trust UK and had several travel grants from Servier (before 1999), Novo Nordisk (before 1999), and Elly Lilly (before 1999). SS is also ethics review committee chairman of the Faculty of Medicine and Allied Sciences Rajarata University of Sri Lanka. TAL has declared that no competing interests exist.
Citation: Lang T, Siribaddana S (2012) Clinical Trials Have Gone Global: Is This a Good Thing? PLoS Med 9(6): e1001228. doi:10.1371/journal.pmed.1001228
CONTACT:
Trudie Lang
Centre for Tropical Medicine
University of Oxford
Oxford
United Kingdom
trudie.lang@ndm.ox.ac.uk
Journal
PLoS Medicine