Rationale

A working group of core contributors should be convened early in the trial process. This group will set authorship criteria that will guide authorship decisions

Description

• This working group should include core trial contributors with broad representation from multiple disciplines, including the trial Steering Committee, clinical investigators with relevant expertise, study co-sponsors, and external experts
• Where possible, working group members should remain unchanged throughout the study to help ensure continuity. Members of the working group need not be authors, nor should they be guaranteed authorship without meeting authorship criteria for the trial
• For smaller trials where an authorship working group is not feasible, this committee may be a subcommittee of a larger Trial Steering Committee where one exists

Rationale

Authorship criteria should be determined early and clearly communicated to ensure all participants are aware of requirements prior to initiation of significant trial activities.

Description

• The authorship working group has responsibility to prospectively determine which contributions will qualify as “substantial” in the context of trial activities
• Trial activities meriting an invitation for authorship should be evaluated by their ability to affect broader trial outcomes compared to those serving a more narrow function
• Definitions for substantial contributions can differ between trials, provided external guidelines such as those of ICMJE are followed, as trial activities vary greatly across therapeutic areas, stages of development, sponsors, and other dimensions
• For large, multinational trials, it is important to clearly define substantial contribution criteria early, given the large number of contributors involved
• Standardized language for those criteria should be included in written publication agreements where possible and agreed to by all trial contributors, including those in the authorship working group

Rationale

Relevant activities from trial contributors should be tracked and annotated to provide the documentation to support objective and unbiased authorship decision making

Description

• The authorship working group should create a process for tracking and documenting all relevant trial contributions that meet the predefined criteria as substantial
• This process should be made transparent in the written publication agreement, and trial contributors should be notified of the requirement to provide this information as part of ongoing trial responsibilities
• To avoid creating new tasks and expense, tracking should be included among normal trial activities where possible

Rationale

Using the documented trial contributions provides an objective, data-driven approach for determining substantial contribution and determining who merits an invitation to authorship

Description

• Once trial activities for a given study are completed, the authorship working group should reconvene to apply the criteria to the documented contributions
• All trial contributors, regardless of function, responsibility or relationship to trial sponsor(s), meeting the predetermined authorship criteria should then be invited to draft/revise the manuscript
• An invitation for authorship may be declined by a contributor
• While up-front participation is preferred, later contributions sometimes rise to the level of a substantial contribution
• The authorship working group should determine which potential authors made a substantial contribution and adjudicate disagreements that arise
• Contributions that do not meet the standard for “substantial” should be agreed to by all authors and noted in the acknowledgements

Rationale

Authors should fulfill the remaining ICMJE authorship criteria beyond substantial contribution outlined in the written publication agreement

Description

• The final responsibility of the authorship working group is to ensure timely dissemination of findings that are consistent with the prespecified aims of the trial
• Those who accept an invitation to draft/revise the manuscript will serve as the initial author list and should agree on their role prior to drafting the manuscript
• All contributions to the manuscript should be fully documented
• Changes to the author list can occur, either adding those who make a later substantial contribution or removing those who do not fulfill all authorship requirements. All authorship changes and the accompanying rationale should be documented and agreed to by the entire author list
• At submission, the authors should consider providing a summary of the author list and their specific contributions to indicate how authorship was determined

• Recruiting alone should not qualify as a substantial contribution unless clear intellectual insight is involved

• Timing of substantial contribution should not play a role
• Must be agreed upon by entire author list prior to submission

• Authorship cannot be compelled, but acknowledgement is encouraged
• All contributions should be included in documentation
• Agreed upon by entire author list prior to submission

• Medical writers should be treated as trial contributors
• All relevant contributions should be documented and those individuals making substantial contribution warrant invitation for authorship

• External contracted work should be cataloged and evaluated for potential substantial contribution equally with other work

• Lead investigator should be empowered to ensure approval
• Any change to the byline or acknowledgements must be agreed upon by entire author list, prior to submission
• Unresponsive authors should be removed and acknowledged

• Data confidentiality does not trump transparency of recognition
• Departing contributors should not be cut off from study
• Contributions must be evaluated through authorship criteria
• Authorship decision needs to be made prior to submission