Professional Medical Writer Assistance in Oncology Clinical Trials

Abstract

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 http://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.

Prevalence, trends, and characteristics of trials investigating local therapy in contemporary phase 3 clinical cancer research

“…It is important to note that this study does not suggest that there are inherent differences between the research of for‐profit and nonprofit funding sources, and for‐profit sources are important vehicles for innovation. The above findings do, however, raise questions about the influence of funding sources in oncology research and how anticipated revenue streams may impact the types of trials conducted as well as their design, accrual, reporting, and outcomes 14–20 ,. 33‐40 In recent years, the majority of phase 3 trials have been funded by industry 14,41,42 .…”

“…The above findings do, however, raise questions about the influence of funding sources in oncology research and how anticipated revenue streams may impact the types of trials conducted as well as their design, accrual, reporting, and outcomes. [14][15][16][17][18][19][20][33][34][35][36][37][38][39][40] In recent years, the majority of phase 3 trials have been funded by industry. 14,41,42 It is worth noting that the process for approving new pharmaceuticals in the United States is different from the process of approving new surgical equipment or adopting new radiotherapy techniques.…”

“…Numerous studies have examined trends of late‐phase research such as funding, leadership, impact factor, and outcomes reporting, among other topics 7 ,. 12–21 However, although the majority of patients with cancer are treated with LT at some point during the cancer care continuum, the proportion of late‐phase clinical trials investigating LT remains unknown 22,23 …”

“…Numerous studies have examined trends of late-phase research such as funding, leadership, impact factor, and outcomes reporting, among other topics. 7,[12][13][14][15][16][17][18][19][20][21] However, although the majority of patients with cancer are treated with LT at some point during the cancer care continuum, the proportion of late-phase clinical trials investigating LT remains unknown. 22,23 Understanding the representation of LT in late-phase clinical trials and factors associated with LT trials may inform future resource allocation, research priorities, and strategic initiatives in the cancer research community.…”

Evolution of the Randomized Clinical Trial in the Era of Precision Oncology

“…Finally, more than one-third of RCTs in the present study cohort involved a medical writer, a trend that has skyrocketed in recent years, with 67% of RCTs published in 2020 from the cohort using medical writers (Figure 3). This is consistent with recent work by Kouzy et al, who reported that 43% of oncology RCTs used professional medical writers. There is reason to be concerned that medical writers may unduly influence the interpretation of trials.…”