Professional Medical Writer Assistance in Oncology Clinical Trials

摘要

Background The use of professional medical writers (PMWs) has been historically low, but contemporary data regarding PMW usage are scarce. In this study, we sought to quantify PMW use in oncologic phase III randomized controlled trials (RCTs). Methods We performed a database query through ClinicalTrials.gov to identify cancer-specific phase III RCTs; we then identified whether a PMW was involved in writing the associated trial manuscript reporting primary endpoint results. Results Two-hundred sixty trials of 600 (43.3%) used a PMW. Industry-funded trials used PMWs more often than nonindustry trials (54.9% vs. 3.0%, p .001). Increased PMW usage was further noted among trials meeting their primary endpoint (53.4% vs. 32.9%, p .001) and trials that led to subsequent Food and Drug Administration approval (63.1% vs. 36.3%, p .001). By treatment interventions, PMW use was highest among systemic therapy trials (50.2%). Lastly, the use of PMWs increased significantly over time (odds ratio: 1.11/year, p = .001). Conclusion PMW use rates are high among industry-funded trials. We urge continued and increased transparency in reporting the funding and use of PMWs.