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Thursday, April 16, 2015

Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results

PLOS: open access

.....The Declaration of Helsinki and other statements have outlined the compelling reasons why interventional clinical trials should be reported in a timely fashion [810]. In brief, not reporting clinical trial results is likely to lead to dissemination bias. This bias has the following major adverse consequences:
  • It affects understanding of the scientific state of the art.
  • It leads to inefficiencies in resource allocation for both research and development and financing of health interventions.
  • It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.
  • It potentially distorts regulatory and public health decision making.
Furthermore, it is unethical to conduct human research without publication and dissemination of the results of that research. In particular, withholding results may subject future volunteers to unnecessary risk......

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