Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil

Abstract

The purpose of this text is to present the discussions about the registration of clinical trials which are currently underway worldwide and discuss the possibilities for international insertion available to Brazil. Clinical trials are one of the most valuable sources of evidence about the effectiveness and safety of health interventions. However, this evidence is disseminated mainly through scientific journals and is therefore subject to the so-called publication bias: articles which present statistically significant results, obtained through large-scale, good quality studies and which are favorable for the industry, have a higher chance of being published. Registering clinical trial protocols in public databases, from their outset, has been proposed as an alternative solution to minimize this problem. A register of clinical trials has been defended for many other reasons – ethical, health, scientific and economic. However, there is no consensus on the principles which should govern these registers or how to operationalize them, due to the divergent interests of researchers, the pharmaceutical industry, government and society.