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Mar 23, 2016

Conditions for making trial data available to other investigators..

Conditions for making trial data available to other investigators

Julian F Bion. Professor of intensive care medicine
University Department of Anaesthesia and Intensive Care Medicine, Queen Elizabeth Hospital Heritage Site, Birmingham B15 2TH, UK

I am confident that the critical care community, including the researchers who undertook the CHEST trial and other landmark studies in this area,1 would support making trial data available to other investigators, provided certain key conditions are met to ensure proper use and interpretation of the data. These conditions could include the following elements:

     • The data should to be placed in a secure repository managed by an independent data trustee such as a research organisation or professional society with secure governance processes

  • The trustees should incorporate ethical, legal, and scientific expertise and patient representation

  • The metadata should be publicly visible through the data trustee’s website

  • Access to the data should be limited to that needed to answer previously defined scientific questions

  • The proposed analysis should be published in a peer reviewed journal before access is permitted

  • The limits of secondary analyses, the risks of misinterpretation, and the statistical approach to minimising bias should be specified in the protocol

  • The full cost of accessing the data should be covered by the applicant not the data trustee

 • The outputs from the analyses should be submitted for publication in peer reviewed journals

 • The outputs from the secondary analyses would be held by the independent data trustee and made publicly available after publication.

The CHEST trial was conducted in a complex environment to the highest possible standard by individuals of impeccable integrity. Had the results supported the use of starches, it is unlikely that the current critics would have raised methodological objections.

For clarity, please note I have previously expressed support for the withdrawal of starch solutions.2 3

Competing interests: I have previously stated my support for the withdrawal of starch based solutions, as described in the references.

 1  Doshi P. Data too important to share: do those who control the data control the message?BMJ 2016;352:i1027

        2.  Bion J, Bellomo R, Myburgh J, Perner A, Reinhart K, Finfer S. Hydroxyethyl starch: putting patient safety first. Intensive Care Med 2014;40:256-9 

        3.  Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K. all co-signatories. Open letter to the Executive Director of the European Medicines Agency concerning the licensing of hydroxyethyl starch solutions for fluid resuscitation. Br J Anaesth 2014;112:595-600. .

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/ permissions 

From: Duygu K. Irmak 

 

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