DOI: 10.6084/m9.figshare.29072643
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

description: 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. 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. 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> &lt; 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). 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. Timely publication of results from clinical studies supports healthcare professionals and patients and informs clinical practice. The World Health Organization recommends submission of the main findings of a clinical study to a journal within 12 months of trial completion. We searched for phase III cancer clinical trials published from 2019 to 2023 in two general medicine journals, The <i>Lancet</i> and the <i>New England Journal of Medicine</i>. We compared the duration of time from when data was available (this served as the start date) to the publication date between papers with and without medical writing support. Medical writing support, defined as support from a professional medical writer, was identified from the acknowledgements section of a paper. We identified a total of 164 papers reporting results from cancer studies. Most papers had medical writing support, 74%. Papers with medical writing support were published in an average of 10 months and papers without medical writing support were published in an average of 15 months. For papers with medical writing support, the time to publication was similar across calendar years. Similarly, the year of publication did not appear to affect time to publication for papers without medical writing support, although there were few papers identified in our analysis in 2020 and 2021. In conclusion, medical writing support is associated with timely publication of clinical trials, even during events such as the coronavirus disease 2019 pandemic.