Data Ownership & Publishing – International Surgical Trials Toolkit

Publication Models

General Considerations

Data Ownership

There are two main authorship models:

Collaborative/corporate authorship.
Within the corporate authorship model, publications are attributed to the collaborative group. Recent publications of surgery trials using this model include the FOxTROT Pilot Trial (1) and the DREAMS Trial (2).
1. Feasibility of preoperative chemotherapy for locally advanced, operable colon cancer: the pilot phase of a randomised controlled trial. The FOxTROT Collaborative Group, Lancet Oncol. 2012; 13:1152-60.
2. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). DREAMS Trial Collaborative and the West Midlands Research Collaborative. BMJ 2017; 357:1455.
Named authorship.
A publication using the named authorship model lists the names and affiliations of the writing group in the paper byline.

The publication policy should be detailed in the regulatory approved protocol. This policy should be developed and agreed in advance by the Trial Management Group.

The publication policy should be clear and transparent.

All collaborators should be aware of the policy when agreement is made to participate.

Irrespective of the authorship policy adopted, publication authorship should conform to the International Committee of Medical Journal Editors (ICMJE) recommendations. The ICMJE defines four criteria for named authorship:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
Drafting the work or revising it critically for important intellectual content; AND
Final approval of the version to be published; AND
Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Authorship of Secondary Publications

The publication policy should also define the authorship for any secondary publications and presentations prepared by the trial collaborators.

Usually, any secondary publications and presentations prepared by collaborators should be agreed, reviewed and approved by the Trial Management Group.

The timing of publication of secondary manuscripts should be agreed prior to the start of the trial. It is accepted practice that the primary publication will take priority over any secondary outputs. This should be detailed in the protocol and, for additional clarity, may also be included within the contracts between Sponsor and collaborating sites.

Depending on the collaborative model of working, there are different considerations regarding data ownership which should be considered prior to the start of a trial.

Data ownership should be defined in the contract between collaborators in a clinical trial and between the Sponsor and participating sites.

‘Data’ means information which is either Personal Data or non-Personal Data collected and/or used for the purposes of the research (trial). Data can be processed manually, electronically or by other means.

‘Results’ means any data or information generated by the research (trial).

The two main models are:

Trial coordinated from the UK with non-UK collaborating sites.
A trial using parallel protocols, with a meta-analysis planned at the end.

Trial coordinated from the UK with non-UK collaborating sites.

In general, if the trial is funded by and coordinated from the UK, the data generated and the results which arise from the trial, would be owned by the body contracting with the funder. This tends to be, but isn’t always, the sponsor of the clinical trial.