Clinical Trials Have Gone Global: Is This a Good Thing?

Plosmedicine.org: June 12, 2012.
Clinical trials are needed globally to reduce disease burdens by helping developing safe and effective new therapies and vaccines. These solutions may be for non-communicable diseases like cancer and diabetes, or, as is especially needed in the poorest regions of the world, infectious disease. Developing countries are under-represented in research due to lack of commercial viability and trained researchers, yet it is in these poorest regions where research-led solutions could bring the greatest impact to high rates of early mortality.
As a research tool clinical trials are fundamental in the effort to develop new products by gaining the data required by regulators, whether for product license extensions for existing therapies for common ailments or to bring cutting edge new therapies and vaccines into approved use. However, there is also a need for clinical trials to bring evidence to determine how to improve the management of health issues; these studies often do not involve a medicinal product but instead compare different options, such as different types of management of an illness in hospital with community-based care. Or, for example, a clinical trial might be used to assess different mechanisms to improve patient adherence to therapy. These pragmatic disease management trials can bring about significant improvements in public health and often require large yet simple trial designs. Read More