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"Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject" Declaration of Helsinki, World Medical Association.
An important proportion of clinical trials that have been completed are never published or their results are partially reported.
The World Health Organization regards trial registration as the publication of an internationally-agreed set of information about the design, conduct and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards.
"Clinical trial registration is now an essential part of the scientific process and is assumed to reduce bias in health literature, promote higher levels of research accountability, address selective reporting, and make trial data accessible for completed and ongoing trials.'' ¹ It enhances transparency and public trust in the conduct of clinical research, and gives visibility to new research so that it can be considered in reviews of the scientific literature.
Within the Knowledge Management, Bioethics and Research Department, the Knowledge Translation program provides technical cooperation to facilitate the implementation of the trial registration initiative in the Americas as well as regional support to the WHO International Clinical Trials Registry Platform (ICTRP).
Main features of the program:
Trial Registration in the Americas
There are also numerous initiatives related to the creation of national trial registries in the Americas Three registries from the Americas are part of the WHO Registry Network or provide data to the ICTRP and there are other research registries available in the region:
Click the red buttons to go to each country national trial registries.
A growing number of clinical trials have been registered over time in the Americas
Search: June 23, 2014. LAC: Latin America and the Caribbean
Search: June 23, 2014.
Reporting Research Findings
Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. Declaration of Helsinki, World Medical Association.
Having access to knowledge resulting from the findings of research is essential to take well-informed decisions about healthcare. However, a significant proportion of clinical trials remain unpublished or even when published, their results are partially reported. Greater accessibility to the findings of all clinical trials will lead to improvements in health and health care.
The U.S. National Institutes of Health launched in 2008 the ClinicalTrials.gov results database (basic search) that includes registered and completed studies in a standard and tabular format. The results information that is submitted by the study sponsor or principal investigator includes the following:
- Participant Flow.
- Baseline Characteristics.
- Outcome Measures and Statistical Analyses.
- Adverse Events.
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- Freitas CG, Pesavento TF, Pedrosa MR, Riera R, Torloni MR. Practical and conceptual issues of clinical trial registration for Brazilian researchers. Sao Paulo Med J. 2015 Aug 21:0. [Epub ahead of print]
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- Viergever RF et al. The quality of registration of clinical trials: still a problem. PLoS One. 2014;9(1):e84727.
- Hartung DM et al. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014 Apr
- IMPACT Observatory started
- Krleža-Jeri? K. Sharing of clinical trial data and research integrity. Periodicum Biologorum. 116(4):337-339, 2014
- Reveiz L et al. Compliance with clinical trial registration and reporting guidelines by Latin American and Caribbean journals. Cad Saude Publica. 2013;29(6):1095-100.
- Viergever RF et al. Use of data from registered clinical trials to identify gaps in health research and development. Bull World Health Organ. 2013;91(6):416-425C.
- Riveros C et al. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals. PLoS Med. 2013 Dec;10(12):e1001566;
- Reveiz L et al. Characteristics of randomized trials published in Latin America and the Caribbean according to funding source. PLoS One. 2013;8(2):e56410.
- Cepeda MS. From ClinicalTrials.gov trial registry to an analysis-ready database of clinical trial results. Clin Trials. 2013;10(2):347-8.
- IMPACT initiative
- Califf RM et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012;307(17):1838-47.
- Reveiz L et al. Trial registration in Latin America and the Caribbean's: study of randomized trials published in 2010. J Clin Epidemiol. 2012;65(5):482-7.
- Prayle AP et al. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012 Jan 3;344:d7373. doi: 10.1136/bmj.d7373.
- Ross JS et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292. doi: 10.1136/bmj.d7292.
- White L et al. Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers. Rev Panam Salud Publica. 2011;30(5):445-52.
- Reveiz L et al . Progress and challenges of clinical trials registration in Latin America and the Caribbean's. Rev Peru Med Exp Salud Publica. 2011 Dec;28(4):676-81.
- Krleža-Jeriç K et al. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency. Rev Panam Salud Publica. 2011;30(1):87-96.
- Reveiz L et al. Reporting of methodologic information on trial registries for quality assessment: a study of trial records retrieved from the WHO search portal. PLoS One. 2010 Aug 31;5(8):e12484.
- Reveiz L et al. Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals. J Clin Epidemiol. 2010;63(11):1216-22.
- Ross JS et al Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis.
- Krleza-Jeric K et al. Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials. Croat Med J. 2009; 50: 105-10.
- Ghersi D et al. From Mexico to Mali: four years in the history of clinical trial registration. Journal of Evidence-Based Medicine.
- Clinical trials registry advances in Latin America and the Caribbean. Newsletter VHL 086 21/January/2009
- Ghersi D et al Reporting the findings of clinical trials: a discussion paper. Bulletin of the World Health Organisation. Bulletin of the World Health Organisation. 2008; 86(6).
- Lee K et al. Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis. PLoS Med. 2008 Sep 23;5(9):e191.
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- International dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR meeting Krleža-Jeric K. International dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR meeting. Croat Med J. 2008 Apr;49(2):267-8.
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- Krleža-Jeri? K. International Dialogue on the Public Reporting Of Clinical Trial Outcome and Results - PROCTOR Meeting. Croatian Medical Journal. 49:267-268, 2008 (doi: 10.3325/cmj.2008.2.267)
- Title VIII - Clinical Trial Databases United States of America . Food and Drug Administration Amendments Act of 2007. Title VIII - Clinical Trial Databases, p82-140, 27 Sep 2007.
- Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil (only in Portuguese) Jose da Rocha Carvalheiro, Cristiane Quental. Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil . RECIIS, Vol 1, No 1 (2007), DOI: 10.3395/reciis.v1i1.42en>
- New standards for registration of human medical research World Health Organization (2006) World Health Organization International Clinical Trials Registry Platform. New standards for registration of human medical research.
- Issues in the Registration of Clinical Trials Zarin DA, Ide NC, Tse T, Harlan WL, West JC, Lindberg DAB. Issues in the Registration of Clinical Trials. JAMA. 2007; 297:2112-2120.
- Do trialists endorse clinical trial registration? Reveiz L, Krleža-Jeric K, Chan A-W, De Aguiar S. Do trialists endorse clinical trial registration? Survey of a Pubmed sample. Trials. 2007 Oct 23;8:30.
- Clinical Trials Register Platform for Latin America and the Caribbean (238.75 KB) BIREME/PAHO/WHO. Sao Paulo: 2007 This report is still a preliminary vision for a Clinical Trial Register Platform for LAC. However, it collects and presents valuable information to accomplish the task and foster further discussion and more detailed specifications. Future versions of this document will give further information about lacking details such as data preparation and how the search and retrieval engine is supposed to work.
- Clinical Trial Registration: Looking Back and Moving Ahead Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, Haug C, Hébert PC, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van Der Weyden MB, Verheugt FW. Clinical Trial Registration: Looking Back and Moving Ahead. Ann Intern Med. 2007 Aug 21;147(4):275-7.
- WHO clinical trials initiative to protect the public. Bulletin of the WHO 2006;84,1
- Options For Improving Public Access To Information On Clinical Trials Of Health Products In Canada. Health Canada : External Working Group On The Registration And Disclosure Of Clinical Trial Information (EWG-CT).Options For Improving Public Access To Information On Clinical Trials Of Health Products In Canada. Dec 2006.
- Reveiz L et al. El registro internacional de ensayos clínicos (only available in Spanish). Rev Panam Salud Publica. 2006;19(6):417-422.
- PAHO's position paper (including Pan American Journal of Public Health) on trial registration:. El registro internacional de ensayos clínicos [The International Clinical Trial Registry]. Rev Panam Salud Publica. 2006;19(6):365-370.
- Ida Sim et al Clinical trial registration: transparency is the watchword The Lancet 2006; 367:1631-1633.
- Gülmezoglu M et al. WHO Facilitates International Collaboration in Setting Standards for Clinical Trial Registration. The Lancet, 2005. 365:1829-1831.
- DeAngelis CD et al. Is This Clinical Trial Fully Registered?: A Statement From the International Committee of Medical Journal Editors JAMA 2005.
- Fair Access to Clinical Trials United States of America . 109th Congress Bill S. 470: Fair Access to Clinical Trials Act of 2005.
- Clinical trial registration Reveiz L, Cardona AF, Ospina Clinical trial registration. N Engl J Med. 2005;352(2):198-9.
- DeAngelis C, Drazen JM, Frizelle FA, Haud C, Hoey J, et al. (2004) Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 351: 1250-1.
- Krleža-Jeri? K., Chan A.W., Dickersin K., Sim I., Grimshaw J., Gluud C. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ. 330:956-958, 2005 (doi: 10.1136/bmj.330.7497.956)
- Krleža-Jeri? K., Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group. PLoS Med. 2:e378, 2005 (doi: 10.1371/journal.pmed.0020378)
- Evans T et al. Registering Clinical Trials: An Essential Role for WHO. The Lancet, 2004. 363:1413-1414.
- WHO - The Mexico Statement on Health Research
- WHO - 58th Meeting of The World Health Assembly