Professor Phillipa Hay Centre for Health Research, School of Medicine

Where science is no longer the domain of the chosen few who write for and read peer review journals. Reference: 2

2012 Science as an Open Enterprise Report 3

 “Science is vital to many of the dilemmas that confront us, but needs to be communicated intelligently, by which we mean it must be supported by evidence, which must be accessible, intelligible, and usable. The internet and other digital technologies offer great ways for scientists to feed these wider demands for information and evidence”  “We must treat scientific data as a public rather than a private resource, exploit the collective intelligence of the scientific community through collaboration and invest in the infrastructure required to make most of the data” Reference: enterprise/report/

 Scientists need to be more open among themselves and with the public and media.  Greater recognition needs to be given to the value of data gathering, analysis and communication.  Common standards for sharing information are required to make it widely usable  Publishing data in a reusable form to support findings must be mandatory.  More experts in managing and supporting the use of digital data are required.  New software tools need to be developed to analyse the growing amount of data being gathered. Reference: 5

Trials (2015) 16:151 DOI /s

 “Even for studies following ‘gold standard’ reporting and open data policies, researchers face difficulties in replicating them…  …Controversial data are attractive to investigators and editors, making contradictory results more likely to be published than confirmatory ones…  …Space pressures cause bias in favour of selecting those outcomes and analyses that are statistically significant”  From: Trials (2015) 16:151 DOI /s

 Registering trials and publishing protocols which specifying the research outcomes and methods.  Use of reporting guidelines such as the CONSORT statement  Or  Research as a “living document”  From: Trials (2015) 16:151 DOI /s

 “not a sealed black box”.  It can be updated, amended, extended …  “It is time for the research article to move beyond the now-obsolete print model and truly embrace the freedom that online publication gives us”  From: Trials (2015) 16:151 DOI /s

Workflow for a living document of a randomized controlled trial. Shanahan Trials :151

 No page limits  No limits to numbers of supplementary files

 Using data to underpin secondary research ◦ conducting systematic reviews for The Cochrane Library

 Protocol is published - citation  Search undertaken, data extracted and entered in review  Peer review – review published – citation 2  Comments and responses published  Review updated – citation 3

 “Dead” between citations  Not open access  But data is published – all is secondary data and some is “shared” from authors  “Ideal” of being provided with primary data rarely achieved

Some journals facilitate this – PLoS Med/One

 The elusive prospective analysis plan ◦ One paper did this ◦ Authors often using HREC protocols and similar  Telling the whole story ◦ Especially if there is no pre-specified plan ◦ One study provided a full time line of analyses including reviewer comments  Sharing the data- data availability statement ◦ 4/17 referenced deposited data in e.g. Open Science Framework (

◦ Data auspiced by Ethics Committees & to be destroyed ◦ Need permission from participants/HREC ◦ Data is ‘owned’ by someone else ◦ Fear of misuse of data

 Touyz et al. (2013) Treating Severe and Enduring Anorexia Nervosa: A Randomized Control Trial Psychological Medicine 43(12):  9 publications, one book and counting  How much more with open data??