Moamen Hammad, Thomas Carvell-Miller, Bernard Kerr, Valerie Moss
{"title":"评估使用专业医学作者是否与在两个高影响力的普通医学期刊上发表III期肿瘤临床试验报告的时间有关。","authors":"Moamen Hammad, Thomas Carvell-Miller, Bernard Kerr, Valerie Moss","doi":"10.1080/03007995.2025.2505697","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Professional medical writers assist authors with ethical and accurate publication of scientific research. We hypothesized that the support of a medical writer would enable timely publication of research and explored their association using papers reporting phase III oncology trials from 2019-2023. Given the time frame of this research, we also assessed the impact of the coronavirus disease 2019 (Covid-19) pandemic on publication volume as a secondary objective.</p><p><strong>Methods: </strong>We searched PubMed for phase III clinical trials published in <i>New England Journal of Medicine</i> (<i>NEJM)</i> and the <i>Lancet</i> between 01/01/2019 and 12/31/2023. Publications reporting oncology trials were reviewed in full to document acknowledgement of medical writing support, data cut-off date, publication date and other key characteristics. Time from data cut-off to publication was compared for papers with and without medical writing support.</p><p><strong>Results: </strong>Our search identified 442 papers reporting any phase III clinical trials, of which 164 (37%) reported oncology trials; 122/164 (74%) disclosed medical writing support. Mean time to publication was significantly shorter for papers disclosing medical writing support than those without (307 vs. 466 days; <i>p</i> < 0.0001). Median time to publication for papers with medical writing support appeared stable from 2019 to 2023. The volume (oncology and non-oncology) of phase III trials published in <i>NEJM</i> and the <i>Lancet</i> between 2019 and 2023 was lowest during 2020 to 2022 (<i>n</i> = 70-88) and highest in 2023 followed by 2019 (<i>n</i> = 110 and <i>n</i> = 96, respectively).</p><p><strong>Conclusions: </strong>Medical writing support is associated with timely publication of clinical trial results, even during events that may disrupt publication development such as the Covid-19 pandemic.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-7"},"PeriodicalIF":2.4000,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Assessment of whether use of a professional medical writer is associated with time to publication of papers reporting phase III oncology clinical trials in two high-impact general medicine journals.\",\"authors\":\"Moamen Hammad, Thomas Carvell-Miller, Bernard Kerr, Valerie Moss\",\"doi\":\"10.1080/03007995.2025.2505697\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Professional medical writers assist authors with ethical and accurate publication of scientific research. We hypothesized that the support of a medical writer would enable timely publication of research and explored their association using papers reporting phase III oncology trials from 2019-2023. Given the time frame of this research, we also assessed the impact of the coronavirus disease 2019 (Covid-19) pandemic on publication volume as a secondary objective.</p><p><strong>Methods: </strong>We searched PubMed for phase III clinical trials published in <i>New England Journal of Medicine</i> (<i>NEJM)</i> and the <i>Lancet</i> between 01/01/2019 and 12/31/2023. Publications reporting oncology trials were reviewed in full to document acknowledgement of medical writing support, data cut-off date, publication date and other key characteristics. Time from data cut-off to publication was compared for papers with and without medical writing support.</p><p><strong>Results: </strong>Our search identified 442 papers reporting any phase III clinical trials, of which 164 (37%) reported oncology trials; 122/164 (74%) disclosed medical writing support. Mean time to publication was significantly shorter for papers disclosing medical writing support than those without (307 vs. 466 days; <i>p</i> < 0.0001). Median time to publication for papers with medical writing support appeared stable from 2019 to 2023. The volume (oncology and non-oncology) of phase III trials published in <i>NEJM</i> and the <i>Lancet</i> between 2019 and 2023 was lowest during 2020 to 2022 (<i>n</i> = 70-88) and highest in 2023 followed by 2019 (<i>n</i> = 110 and <i>n</i> = 96, respectively).</p><p><strong>Conclusions: </strong>Medical writing support is associated with timely publication of clinical trial results, even during events that may disrupt publication development such as the Covid-19 pandemic.</p>\",\"PeriodicalId\":10814,\"journal\":{\"name\":\"Current Medical Research and Opinion\",\"volume\":\" \",\"pages\":\"1-7\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-05-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Medical Research and Opinion\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/03007995.2025.2505697\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Medical Research and Opinion","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/03007995.2025.2505697","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Assessment of whether use of a professional medical writer is associated with time to publication of papers reporting phase III oncology clinical trials in two high-impact general medicine journals.
Objective: Professional medical writers assist authors with ethical and accurate publication of scientific research. We hypothesized that the support of a medical writer would enable timely publication of research and explored their association using papers reporting phase III oncology trials from 2019-2023. Given the time frame of this research, we also assessed the impact of the coronavirus disease 2019 (Covid-19) pandemic on publication volume as a secondary objective.
Methods: We searched PubMed for phase III clinical trials published in New England Journal of Medicine (NEJM) and the Lancet between 01/01/2019 and 12/31/2023. Publications reporting oncology trials were reviewed in full to document acknowledgement of medical writing support, data cut-off date, publication date and other key characteristics. Time from data cut-off to publication was compared for papers with and without medical writing support.
Results: Our search identified 442 papers reporting any phase III clinical trials, of which 164 (37%) reported oncology trials; 122/164 (74%) disclosed medical writing support. Mean time to publication was significantly shorter for papers disclosing medical writing support than those without (307 vs. 466 days; p < 0.0001). Median time to publication for papers with medical writing support appeared stable from 2019 to 2023. The volume (oncology and non-oncology) of phase III trials published in NEJM and the Lancet between 2019 and 2023 was lowest during 2020 to 2022 (n = 70-88) and highest in 2023 followed by 2019 (n = 110 and n = 96, respectively).
Conclusions: Medical writing support is associated with timely publication of clinical trial results, even during events that may disrupt publication development such as the Covid-19 pandemic.
期刊介绍:
Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance