The International Registry of Clinical Trials
Article published in: Cuervo LG, Valdés A, Clark ML. The international registry of clinical trials [editorial]. Rev Panam Salud Publica. 2006; 19 (6): 365-70. Available in http://journal.paho.org/index.php?a_ID=510 Authorized for reproduction in the Uruguayan Medical Journal
Abstract
In recent years, a series of particularly notorious scandals has undermined public confidence in clinical research and its results. Specific cases of data manipulation in clinical trial registers and modification of research protocols without justification or without leaving a record have come to light, as well as other reprehensible practices (1). A recent systematic review of the literature revealed, for example, that the results of trials with certain antipsychotic drugs tended to favor the source of funding for the study (2). The adverse impact of such incidents has harmed the entire investigative community, not just those directly responsible. Partial, sometimes deliberate, access to many publicly funded research results has also been censored. As a result, the scientific community has to take steps to restore general confidence in medical research and avoid biases and misrepresentations in the generation and transmission of its results. The registration of all clinical trials in a database that is available to the public is a measure that has been proposed for several years to counteract these trends.
References
(2) Marshall E. Antidepressants and children. Buried data can be hazardous to a company. Science. 2004; 304(5677):1576-7.
(3) Tonks A. Aclinical trials register for Europe. BMJ 2002; 325(7376): 1314-5.
(4) Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principios del registro internacional de protocolos y resultados de ensayos clínicos a base de intervenciones de salud en seres humanos: Declaración de Ottawa (parte 1). Rev Panam Salud Pública. 2006; 19(6):413-6.
(5) Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C. Principles for international registration of protocol information and results from human trials of health interventions: Ottawa statement (part 1). BMJ 2005; 330(7497): 956-8.
(6) World Health Organization. International Clinical Trials Registry Platform (ICTRP). Welcome to the WHO International Clinical Trials Registry Platform. Disponible en: http://www.who.int/ictrp/en/ (Consulta: 31 may. 2006).
(7) International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Disponible en: http://www.icmje.org/ (Consulta: 2 de jun. 2006).
(8) International Federation of Pharmaceutical Manu-facturers & Associations (IFPMA). Posición conjunta de la IFPMA/EFPIA/JPMA/PhRMA sobre la revelación de información de ensayos clínicos mediante registros de ensayos y bases de datos de ensayos clínicos. Disponible en: http://www.ifpma.org/clinicaltrials.html. (Consulta: 31 de may. 2006).
(9) Organización Mundial de la Salud. Consejo Ejecutivo. Función y responsabilidades de la OMS en las investigaciones sanitarias: informe de la secretaría. (117ª reunión: 16 ene. 2006) Disponible en: http://www.who.int/gb/ebwha/pdf_ files/EB117/B117_14-sp.pdf. (Consulta:1º jun. 2006).
(10) Normas para la publicación de investigaciones clínicas patrocinadas por la industria farmacéutica. Rev Panam Salud Publica 2003;14(1):62-6.
(11) Lolas F. La ética de la publicación médica: entre la academia, el estado y la industria. Rev Panam Salud Puública 2003;14(1): 1-2.
(12) Reveiz L, Delgado MB, Urrutia G, Ortiz Z, García M, Martí-Carvajal A, et al. The Latin American Ongoing Clinical Trial Register (LATINREC). Rev Panam Salud Pública 2006; 19(6): 417-22.
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