Article
Laleh Amiri-Kordestani & Richard Pazdur
Professional Medical Writer Assistance in Oncology Clinical Trials
Summary
- The use of professional medical writers (PMWs) in oncologic phase III randomized controlled trials (RCTs) has been historically low, but recent data on their usage is limited.
- This study aimed to quantify the usage of PMWs in cancer-specific phase III RCTs by analyzing trial manuscripts on ClinicalTrials.gov.
- Out of 600 trials, 260 (43.3%) involved PMWs in writing the trial manuscript.
- Industry-funded trials were significantly more likely to use PMWs compared to nonindustry trials (54.9% vs. 3.0%, p < .001).
- PMW usage was higher in trials that met their primary endpoint (53.4% vs. 32.9%, p < .001) and those resulting in FDA approval (63.1% vs. 36.3%, p < .001).
- Among treatment interventions, PMW use was most prevalent in systemic therapy trials (50.2%).
- The study observed a significant increase in the use of PMWs over time (odds ratio: 1.11/year, p = .001).
- The study calls for increased transparency in reporting the funding and use of PMWs.
Academic publishing remains the cornerstone of cancer research and scientific communication of clinical trials. Over the years, there has been increasing interest in the use of professional medical writers (PMWs) to help investigators improve quality of writing and/or reduce the time to publication. Use rates of such PMW services have historically been low, but contemporary data regarding PMW usage remain scarce. With an increasing role of industry sponsorship in cancer clinical trials, we sought to characterize the rate of PMW use among reports of phase III cancer clinical trial results, focusing on factors associated with PMW usage.
PMW usage, phase III oncology trials, professional medical writer assistance
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