Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications

Stocks, A.; Simcoe, Donna; Toroser, Dikran; DeTora, Lisa

doi:10.1080/03007995.2018.1451832

Cited by 33 publications

(46 citation statements)

References 17 publications

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“…Como el verdadero problema radica en definir qué representa una contribución "sustancial", se han propuesto medios para cuantificar el trabajo real reali-zado por autores individuales. A este respecto, se ha sugerido (17) que la contribución sustancial a una publicación consiste en una contribución intelectual importante sin la cual no podría haberse completado una parte del trabajo o incluso todo el trabajo, o no podría haberse escrito el manuscrito (17) .…”

Section: Consideraciones Sobre Los Criterios Clásicos De Autoríaunclassified

“…Idealmente, el equipo de investigación debe definir colectivamente el orden de los autores desde el inicio del proyecto (30) . Luego, al finalizar el trabajo, se debe revisar el orden definitivo de los autores, teniendo en cuenta el nivel real de los aportes de cada uno (17) . Los editores no están en condiciones de juzgar si los autores han cumplido con los criterios de autoría.…”

Section: Ubicación Y Jerarquía En El Encabezado De Autoresunclassified

“…Esto debería diferenciarse de la escritura fantasma. Los escritores fantasmas son aquellos que colaboran en la redacción de un manuscrito sin cumplir con los criterios de autoría, pero en los agradecimientos no se mencio-nan sus aportes (17,38) . La escritura fantasma también es una práctica poco ética, ya que oculta la participación de gente que participó en el manuscrito.…”

Section: Infracciones De Autoría: De Los Autores Fantasmas a Los Autounclassified

“…La escritura fantasma también es una práctica poco ética, ya que oculta la participación de gente que participó en el manuscrito. Lo que preocupa es que sean escritores contratados por la industria que puedan influir en el contenido de la publicación u ocultar resultados no deseados, lo que introduce un posible sesgo que se encubre al acreditar la autoría a importantes autores académicos invitados (17) . Los escritores médicos profesionales deben respetar las prácticas de publicación ética y deben divulgar abiertamente su participación en la sección de reconocimiento (38) .…”

Section: Infracciones De Autoría: De Los Autores Fantasmas a Los Autounclassified

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Autoría: desde el crédito a la responsabilidad. Reflexiones de la Red de Editores

Alfonso¹,

Zelveian²,

Monsuez³

et al. 2019

Rev. Urug. Cardiol.

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Section: Consideraciones Sobre Los Criterios Clásicos De Autoríaunclassified

Section: Ubicación Y Jerarquía En El Encabezado De Autoresunclassified

Section: Infracciones De Autoría: De Los Autores Fantasmas a Los Autounclassified

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Autoría: desde el crédito a la responsabilidad. Reflexiones de la Red de Editores

Alfonso¹,

Zelveian²,

Monsuez³

et al. 2019

Rev. Urug. Cardiol.

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show abstract

“…Alternatively, authors can provide consolidated comments representing the views of more than one author as part of the revision process.If an author has no comments during the review process, they should clearly communicate that they have thoroughly reviewed the manuscript. Some stakeholders may wish to use technology to electronically track the opening and review of documents, but should advise authors in advance if such technology is used.The scope of 'drafting the work or revising it critically for important intellectual content' has not been clearly defined, but proposed definitions of what constitutes a substantial contribution to the development of a manuscript have been published[22]. In the North American and European context; this has been interpreted as authors providing feedback on numerous drafts of a manuscript.…”

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confidence: 99%

A guide to applying the Good Publication Practice 3 Guidelines in the Asia-Pacific region

Hesp¹,

Arai²,

Chu³

et al. 2019

Preprint

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Numerous recommendations and guidelines aim to improve the quality, timeliness and transparency of medical publications. However, these guidelines use ambiguous language that can be challenging to interpret, particularly for speakers of English as a second language. Cultural expectations within the Asia-Pacific region raise additional challenges. Several studies have suggested that awareness and application of ethical publication practices in the Asia-Pacific region is relatively low compared with other regions. However, guidance on applying ethical publication practice guidelines in the Asia-Pacific region is lacking. This review aims to improve publication practices in the Asia-Pacific region by providing guidance on applying the 10 principles of the Good Publication Practice 3 (GPP3) guidelines and the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Recommendations are provided for encore presentations, applying the ICMJE authorship criteria in the context of regional cultural expectations, and the role of study sponsors and professional medical writers. Ongoing barriers to compliance with guidelines are also highlighted, and additional guidance is provided to support authors submitting manuscripts for publication. The roles of regional journals, regulatory authorities and professional bodies in improving practices are also discussed.

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Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

et al. 2023

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ImportanceThe practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated.ObjectiveTo assess characteristics of oncology trials that use medical writers and whether there is an association between the use of medical writers and trial success or the primary outcome evaluated.Design, Setting, and ParticipantsThis cross-sectional study included oncology trials testing a tumor-targeting intervention that were published in The Lancet, The Lancet Oncology, JAMA, JAMA Oncology, Journal of Clinical Oncology, and The New England Journal of Medicine between May 1, 2021, and May 1, 2022.ExposuresAssistance of medical writers or no assistance.Main Outcomes and MeasuresThe main outcomes were the percentage of studies with medical writers, the percentage of trial successes reported with medical writers, the association between trial success and medical writer use, and the association between a primary end point and medical writer use.ResultsAmong 270 studies, 141 (52.2%) included a medical writer and 129 (47.8%) did not include a medical writer. Of the studies that included a medical writer, 83 (58.9%) were successful. Of the studies that did not include a medical writer, 64 (49.6%) were successful (P = .16 for difference). Studies with medical writers were less likely than studies without medical writers to have the end point of overall survival (15 [10.6%] vs 17 [13.2%]) and disease-free or event-free survival (16 [11.3%] vs 29 [22.5%]), whereas studies with a medical writer were more likely to have the end point of progression-free survival (32 [22.7%] vs 17 [13.2%]). Use of medical writer was associated with the conclusions being presented favorably in all studies (113 [80.1%] vs 89 [69.0%]; odds ratio [OR], 1.81 [95% CI, 1.04-3.19]), but when adjusted for other variables, there was no association (OR, 1.84 [95% CI, 0.92-3.72]).Conclusions and RelevanceIn this cross-sectional study, trials using medical writers were more likely to report surrogate end points, such as progression-free survival, and favorable conclusions, but when adjusted for trial phase, randomization, and study funding, there was no association with favorable conclusions. These findings suggest that journals need heightened scrutiny for studies with medical writers and that authorship should be properly acknowledged.

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Substantial contribution and accountability: best authorship practices for medical writers in biomedical publications

Cited by 33 publications

References 17 publications

Autoría: desde el crédito a la responsabilidad. Reflexiones de la Red de Editores

Autoría: desde el crédito a la responsabilidad. Reflexiones de la Red de Editores

A guide to applying the Good Publication Practice 3 Guidelines in the Asia-Pacific region

Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

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