Accomplishment of ethical conditions related to the use of placebos in colombian clinical trials
Abstract
Use of placebos in clinical trials represents an important need in the measurement of the variability of the course of certain diseases and the possibility of spontaneous cure, but despite the existence of regulatory issues regarding use has been many studies use them indiscriminately threatening to those who receive. Use of placebos in clinical trials represents an important need in the measurement of the variability of the course of certain diseases and the possibility of spontaneous cure, but despite the existence of regulatory issues regarding use has been many studies use them indiscriminately and this represent a threatening to those who receive. The objective is review some concepts about placebo and determine compliance of the ethical issues about use of placebo in clinical trials conducted in Colombia by analyzing of the registry in the database of the Food Drug Administration. We found on December 2013 a total of 713 clinical trials registered in Colombia, of which 242 used placebos and 49 of them did not meet the ethical conditions on the use of placebo. This situation leads to think that the information available local and globally for the use of placebo may be insufficient and incomplete and lead to misinterpretation, which could allow the wrong approving of these studies by ethics committees. We don’t have an information system on clinical trials and we cannot determine what the consequences caused this situation in the affected population.
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