Globalization of cardiovascular clinical research: the balance between meeting medical needs and maintaining scientific standards.
A substantial need to conduct research studies and identify effective treatments for cardiovascular diseases in the developing world exists. Careful consideration of several issues is warranted to ensure that clinical trials conducted solely in developing nations are held to accepted scientific standards. Researchers conducting clinical trials in developing countries should critically evaluate the purpose and appropriateness of conducting the trial in the proposed location, the accessibility of the therapy if proven effective, the quality of the informed consent process, the presence of infrastructure to support clinical research, and the translation of data to other populations. This article discusses the importance of these considerations using a recent example of a clinical trial conducted in a developing nation. These and other issues are critical to address as the conduct of cardiovascular clinical trials continues to expand beyond the western world.
Stough
Wendy Gattis
WG
Department of Clinical Research Campbell University School of Pharmacy, Research Triangle Park, NC, USA. stoughw@campbell.edu
Zannad
Faiez
F
Pitt
Bertram
B
Goldstein
Sidney
S
D035843:Biomedical Research / Q000592:standards*; D002318:Cardiovascular Diseases; D002681:China; D002986:Clinical Trials as Topic / Q000592:standards*; D003906:Developing Countries; D006297:Health Services Accessibility; D006801:Humans; D007258:Informed Consent; D038622:Internationality; D016032:Randomized Controlled Trials as Topic