engleski

Deciding authorship: Survey findings from clinical investigators, journal editors, publication planners and medical writers

Objective Low awareness, variable interpretation, and inconsistent application of guidelines can lead to a lack of transparency when recognizing contributors in industry- sponsored clinical trial publications. We sought to identify how different groups who participate in the publication process determine authorship. Design Interviews with clinical investigators, journal editors, publication planners, and medical writers identified difficult-toresolve authorship scenarios when applying ICMJE guidelines, such as authorship for significant patient recruitment or medical writing contribution. Seven scenarios were converted into a case-based, online survey to identify how these groups determine appropriate recognition and provide rationale and confidence for their decision. Respondents also indicated their awareness and use of authorship guidelines. A sample of at least 96 participants per group enabled estimates with a 10% margin of error for a 100, 000 population. The online survey remained open until all groups surpassed this sample size by at least 10%. Results We analyzed 498 responses from a global audience of 145 clinical investigators, 132 publication planners, 113 medical writers, and 108 journal editors. Overall, types of recognition chosen for each scenario varied both within and across respondent groups (see Table 2 for example case results). Despite acknowledged awareness and use of authorship criteria, respondents often adjudicated cases inconsistently with ICMJE guidelines. Clinical investigators provided the most variable responses and had the lowest level of ICMJE awareness (49% [95% CI=42.9-59.4] vs 92% [95% CI=88.5-94.2] for other groups) and use (28% [95% CI=20.5-34.6] vs 61% [95% CI=55.7- 65.5] for other groups). Respondents were confident in their answers (mean score, 2.0 [95% CI=1.5- 2.5] on a relative scale from 1: extremely confident to 6: not at all confident), regardless of their adjudication. Based on roundtable discussions with 15 editors and qualitative analysis of respondents’ answers, Medical Publications Insights and Practices Initiative (MPIP) developed supplemental guidance aimed at helping authors to set common rules for authorship early in a trial and document all trial contributions to increase transparency.Conclusions Groups that participate in the publishing process had differing opinions on adjudication of challenging real-world authorship scenarios. Our proposed supplemental guidance is designed to provide a framework to improve transparency when recognizing contributors to all clinical trial publications.

authorship; clinical trials

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