Editorial

Towards agreement on best practice for publishing raw clinical trial data

Iain Hrynaszkiewicz¹ and Douglas G Altman²

¹  BioMed Central Ltd, 236 Gray's Inn Road, London, WC1X 8HL, UK

²  Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Linton Road, Oxford, OX2 6UD, UK

author email corresponding author email

Trials 2009, 10:17doi:10.1186/1745-6215-10-17

Published:	18 March 2009

Abstract

Many research-funding agencies now require open access to the results of research they have funded, and some also require that researchers make available the raw data generated from that research. Similarly, the journal Trials aims to address inadequate reporting in randomised controlled trials, and in order to fulfil this objective, the journal is working with the scientific and publishing communities to try to establish best practice for publishing raw data from clinical trials in peer-reviewed biomedical journals. Common issues encountered when considering raw data for publication include patient privacy – unless explicit consent for publication is obtained – and ownership, but agreed-upon policies for tackling these concerns do not appear to be addressed in the guidance or mandates currently established. Potential next steps for journal editors and publishers, ethics committees, research-funding agencies, and researchers are proposed, and alternatives to journal publication, such as restricted access repositories, are outlined.