O registro público obrigatório de ensaios clínicos

Abstract

Some recent articles, published simultaneously in several important medical journals such as the New England Journal of Medicine and The Lancet, called the attention to those interested in clinical research [1, 2]. Clinical research is the method of scientific investigation using non-pharmacological or pharmacological therapeutic interventions that involve human beings, analyzing the efficacy and safety of new medications, new surgical techniques or diagnostical investigations. In brief, the articles comment that these journals will demand, starting in September 2005, a prior register of clinical trials in a North American site (www.clinicaltrials.gov) before any articles are accepted for publication. According to the articles, the journals will make this demand in the name of respect and to guarantee access to the information by patients and for public opinion. With this attitude, the periodicals will also try to reduce the possibility of publication bias, a kind of favoring researches with positive results. In other words, scientific works in which the results confirm the expectations of the researchers or sponsors will have a greater chance of success to have their results published. The interest of the reader may explain the occurrence of bias in publishing, though there are already some initiatives in which the priority is research with negative or unexpected results. The access to www.clinicaltrials.gov is free and the initial page requires an individual or group to register in the name of an institution or company. The registration must be completed in English but it is relatively easy. It is an American initiative, but there are already some Canadian and European centers registered, as well as several pharmaceutical companies and the World Heath Organization (WHO) [3]. The curious point of the process, in our view, is that the short list of the 20 prerequisites necessary for the registration of a clinical trial are already practically filled in, when, in Brazil, National Commission on Ethics in Research (CONEP) must be consulted about any project. The on-line registration page of CONEP has all or almost all this