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ictrp

"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

trials-per-year28LAC
Search: June 23, 2014. LAC: Latin America and the Caribbean

 

2-trials-per-year
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. 

Trial Registration initiative over time

2015

2014

2013

2012

2011

2010

 2009

2008

2007

2006

2005

2004