Registro de ensaios clínicos: quando e por que fazer?

Abstract

Clinical trials have been described lately as the gold standard in the evaluation of issues related to treatment and prevention in health 1. The registration of clinical trials has been suggested with the intention of respecting ethical reasons for those who participated in the study and were informed that they would be used to contribute to the advance of science, regardless of the results. It is also a way of guaranteeing that patients and professionals have access to information on studies which are recruiting volunteers for research, as well as trying to avoid the duplication of efforts of performing studies already conducted in the past, stimulating scientific knowledge and cooperation among research groups 2. The registration of clinical trials allows the identification of gaps in the existing knowledge in different areas, the observation of trends in the field of studies and the identification of specialists in the various areas 3. According to the World Health Organization (WHO), randomized control trials and clinical trials must be announced and registered before being commenced. This will allow the identification of all clinical trials underway and their respective results, since not all of them are published in scientific journals. The International Committee of Medical Journal Editors (ICMJE) suggests that scientific journal editors require from authors the registration number at the time of submission of papers 4. Recently the editors of peer-reviewed journals in the Lilacs and Scielo databases, such as the Brazilian Journal of Physical Therapy, received an official report stating that BIREME (Regional Library of Medicine) would begin requiring from journals that publish randomized control trials and clinical trials that they include, in the instruction to the authors, the recommendation for prior registration of clinical trials and that they request the identification number as condition of acceptance of the manuscript. This decision follows the instruction of WHO's and ICMJE's International Clinical Trials Registry Platform (ICTRP). ICMJE defines as a clinical trial every research project that is prospective and assigns patients to clinical or drug intervention, which may interfere in their health, with the purpose of comparing the cause/effect among studied groups. ICMJE stated, in 2004, that its member journals would only accept for publication trials registered in freely accessible public registries, managed by non-profit organizations, having at their disposal mechanisms for validation of registered data and that allow electronic searches 5. WHO proposes a minimal set of information that must be registered on each trail, such as: unique identification number, trial registration date, secondary identities, sources of financing and support material, main sponsor, other sponsors, contact details for public queries, contact details for scientific queries, the study's public title, the scientific title, recruitment countries, health problems studied, interventions, inclusion and exclusion criteria, ...

Practical and conceptual issues of clinical trial registration for Brazilian researchers

“…3,6,8,12,13,15,21 WHO highlights that trial registries can also be sources of evidence on the efficacy and safety of health interventions. 22 The main reasons for clinical trial registration are: a) To avoid publication bias.…”

“…22 The main reasons for clinical trial registration are: a) To avoid publication bias. 3,8,[13][14][15] Registration of a trial protocol, in theory, ensures that the results of that study will be published, regardless of whether the findings were beneficial, harmful, inconclusive or even inefficacious.…”

“…3,8,[13][14][15] Registration of all essential details about outcomes that will be analyzed in the study protocol will preclude authors from selecting which outcome data will later be published.…”

“…3,8,[12][13][14][15] In theory, registration of a trial ensures that both the methods and the results of the study will be published. Through publishing the study, the investigators will fulfill their ethical responsibility to the participants, because the data gathered in the study will be used to advance scientific knowledge.…”

“…Discussions have progressed from theoretical issues, such as the importance of establishing trial registration platforms 1 and the creation of these registries, to regulatory issues involving enforcement of trial registration, such as through publication and legal restraints. [2][3][4][5][6] Many published papers on the history of trial registries are available at the Ottawa Group website, 7 including the 2004 Ottawa Statement, which presents the main principles for development of these registries. 8 Over the last 14 years, the Brazilian government has recognized the strategic importance of scientific research for the country and has created mechanisms and structures to administer and encourage research.…”