Development of a decision-support tool to quantify authorship contributions in clinical trial publications

Purpose: This study aimed to develop a decision-support tool to quantitatively determine authorship in clinical trial publications.Methods: The tool was developed in three phases: consolidation of authorship recommendations from the Good Publication Practice (GPP) and International Committee of Medical Journal Editors (ICMJE) guidelines, identifying and scoring attributes using a 5-point Likert scale or a dichotomous scale, and soliciting feedback from editors and researchers.Results: The authorship criteria stipulated by the ICMJE and GPP recommendations were categorized into 2 Modules. Criterion 1 and the related GPP recommendations formed Module 1 (sub-criteria: contribution to design, data generation, and interpretation), while Module 2 was based on criteria 2 to 4 and the related GPP recommendations (sub-criteria: contribution to manuscript preparation and approval). The two modules with relevant sub-criteria were then differentiated into attributes (n = 17 in Module 1, n = 12 in Module 2). An individual contributor can be scored for each sub-criterion by summing the related attribute values; the sum of sub-criteria scores constituted the module score (Module 1 score: 70 [contribution to conception or design of the study, 20; data acquisition, 7; data analysis, 27; interpretation of data, 16]; Module 2 score: 50 [content development, 27; content review, 18; accountability, 5]). The concept was integrated into Microsoft Excel with adequate formulae and macros. A threshold of 50% for each sub-criterion and each module, with an overall score of 65%, is predefined as qualifying for authorship.Conclusion: This authorship decision-support tool would be helpful for clinical trial sponsors to assess and provide authorship to deserving contributors.