Keynote Speech I

Open access has been proposed as a solution for scientific journals to address growing demands of the public for access to information. Today, different modalities of open access are available even in most prestigious journals. In my speech I will show how the members of the International Committee of Medical Journal Editors (ICMJE, or Vancouver group) addressed another aspect of public access to information – clinical research trials. Over the years, the problem of selective reporting of trials has grown, distorting the body of evidence available for clinical decision-making and thus betraying altruism and trust of individuals who risk their lives volunteering for such trials. Starting from the premise that honest reporting begins with revealing the existence of all clinical studies, ICMJE proposed comprehensive trials registration as a solution to the problem of selective awareness. In its statement from the meeting in Cavtat, Croatia, in 2004, ICMJE announced that all ICMJE member journals would adopt a trials-registration policy to promote public access to information about most important data on clinical trials before the onset of patient enrollment. Three years later, the registration of clinical trials has become a standard of clinical research, and has been promoted by the World Health Organization, which defined the minimal dataset for trial registration and structured a single web-portal for researchers and patients to register trials or find information about ongoing trials. We hope that public registration of clinical trials is an important step in ensuring full transparency of performance and reporting of clinical trials.