ESSAYS ON RESEARCH -- CLINICAL TRIALS HAVE GONE GLOBAL: IS THIS A GOOD THING?

Wednesday, 19th of June 2013

ESSAYS ON RESEARCH -- CLINICAL TRIALS HAVE GONE GLOBAL: IS THIS A GOOD THING?

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

Published: June 12, 2012

Copyright: © 2012 Lang and Siribaddana. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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.

Provenance: Commissioned; externally peer reviewed.

Summary Points below; full text is at http://www.ploscollections.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001228

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.