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

IMPORTANCE: The practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated. OBJECTIVE: To assess characteristics of oncology trials that use medical writers and whether there is an association between the...

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Autores principales: Buck, Eva, Haslam, Alyson, Tuia, Jordan, Prasad, Vinay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9892954/
https://www.ncbi.nlm.nih.gov/pubmed/36723940
http://dx.doi.org/10.1001/jamanetworkopen.2022.54405
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author Buck, Eva
Haslam, Alyson
Tuia, Jordan
Prasad, Vinay
author_facet Buck, Eva
Haslam, Alyson
Tuia, Jordan
Prasad, Vinay
author_sort Buck, Eva
collection PubMed
description IMPORTANCE: The practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated. OBJECTIVE: To 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 PARTICIPANTS: This 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. EXPOSURES: Assistance of medical writers or no assistance. MAIN OUTCOMES AND MEASURES: The 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. RESULTS: Among 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 RELEVANCE: In 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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spelling pubmed-98929542023-02-08 Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals Buck, Eva Haslam, Alyson Tuia, Jordan Prasad, Vinay JAMA Netw Open Original Investigation IMPORTANCE: The practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated. OBJECTIVE: To 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 PARTICIPANTS: This 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. EXPOSURES: Assistance of medical writers or no assistance. MAIN OUTCOMES AND MEASURES: The 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. RESULTS: Among 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 RELEVANCE: In 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. American Medical Association 2023-02-01 /pmc/articles/PMC9892954/ /pubmed/36723940 http://dx.doi.org/10.1001/jamanetworkopen.2022.54405 Text en Copyright 2023 Buck E et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Buck, Eva
Haslam, Alyson
Tuia, Jordan
Prasad, Vinay
Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals
title Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals
title_full Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals
title_fullStr Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals
title_full_unstemmed Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals
title_short Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals
title_sort frequency and characteristics of trials using medical writer support in high-impact oncology journals
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9892954/
https://www.ncbi.nlm.nih.gov/pubmed/36723940
http://dx.doi.org/10.1001/jamanetworkopen.2022.54405
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