Professional medical writing assistance in oncology clinical trials.

Abstract

e14088 Background: Academic publishing remains the cornerstone of biomedical research and scientific communication. Researchers often assign professional medical writers (PMWs) to craft publications, as these individuals may improve the overall writing quality and/or reduce time to publication. We sought to characterize the landscape of PMW utilization in phase III cancer clinical trials. Methods: We searched ClinicalTrials.gov for phase III randomized clinical trials between the years 2003 and 2018. Randomized multi-arm trials assessing a therapeutic intervention in cancer patients were included. After identifying the corresponding publications, we identified whether a PMW was involved in writing the manuscript based on author disclosures, along with any related funding information. Results: Six-hundred oncology RCTs with corresponding manuscripts were identified. In total, 260 (43.3%) trials used a PMW. Financial support to medical writers was largely provided by the industry (247/260, 95.0%). In multivariate analyses, PMW utilization was higher among industry-funded trials compared to non-industry-funded trials (OR: 14.2, p= 0.001). PMWs were used more frequently to report successful trials that met their primary endpoint (OR: 1.8, p= 0.03) but did not differ between English-speaking and non-English-speaking countries ( p= 0.19). Cooperative group trials used PMWs with less frequency compared to non-cooperative groups (OR 0.68, p < 0.001). PMWs were used more often in trials that led to subsequent drug FDA approval (69.6% vs 40.6% in trials that did not lead to subsequent FDA approval), but this association did not reach statistical significance in multivariate analysis ( p = 0.744). The use of PMWs has increased significantly over time (OR: 1.11/year, p =0.001). Conclusions: In this analysis, we show a strikingly high prevalence of PMW utilization in phase III oncology trials, with a vast majority of industry-supported studies using PMWs. We believe that professional writing assistance plays an important role in clear and efficient scientific communication. However, the disproportionate role of PMWs in reporting positive, industry-funded trials may represent a conflict of interest. We urge continued and increased reporting of utilization and funding of professional writing assistance in cancer clinical trials.