Ethical complexities of conducting research in developing countries
Varmus, H.; Satcher, D.
New England Journal of Medicine 337(14): 1003-1005
1997
ISSN/ISBN: 0028-4793 PMID: 9309109 DOI: 10.1056/nejm199710023371411Document Number: 274383
The most compelling reason to use a placebo-controlled study is that it provides definitive answers to questions about the safety and value of an intervention in the setting in which the study is performed, and these answers are the point of the research. Without clear and firm answers to whether and, if so, how well an intervention works, it is impossible for a country to make a sound judgment about the appropriateness and financial feasibility of providing the intervention. If the affordable intervention is less effective than the ACTG 076 regimen-not an unlikely outcome-this information will be of little use in a country where the more effective regimen is unavailable. Equally important, it will still be unclear whether the affordable intervention is better than nothing and worth the investment of scarce health care dollars. Such studies would fail to meet the goal of determining whether a treatment that could be implemented is worth implementing. A placebo-controlled trial is not the only way to study a new intervention, but as compared with other approaches, it offers more definitive answers and a clearer view of side effects.