Clinical Trials in Latin America Conclusion推荐.pdfVIP

Chapter 13 Conclusion Antonio Ugalde and Nuria Homedes The collection of articles included in this book provide an overview of the evolution of the regulatory framework that guides the implementation of clinical trials in five Latin American countries and, through the description and analysis of several cases studies, highlights the main ethical issues that have arisen during the implementa- tion of the trials. More than 80 % of all clinical trials that take place in the region are conducted in Argentina, Brazil, Costa Rica, Mexico and Peru; therefore, what is described in this book can be considered representative of what occurs in the region. The lack of transparency that surrounds clinical trials precludes us from having an accurate picture of the magnitude of the problems that have been described in this volume. The authors of the different chapters only had access to legislative and court documents, a few thesis and dissertations, information discovered after a human tragedy occurred during the implementation of a trial and reports from investigative reporters that took the time to study complains from physicians and other health care providers who reported abuses. We can only assume that the cases presented are not isolated examples. Of the five countries included in the book, Costa Rica and Argentina have a strong tradition of investigative reports and it is for this reason that there is more information about trials in these countries than elsewhere. We have to keep in mind that it took almost 40 years to uncover by incredible chance the clinical trials abuses/atrocities that USA researchers with the assistance of local physicians committed in Guatemala. Perhaps one day, if files of the industry and the archives of governments are opened, researchers will be able to establish the extent of the problem with greater accuracy. In this closing chapter, we will present the main similariti