Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals

Abstract

ImportanceThe practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated.ObjectiveTo assess characteristics of oncology trials that use medical writers and whether there is an association between the use of medical writers and trial success or the primary outcome evaluated.Design, Setting, and ParticipantsThis cross-sectional study included oncology trials testing a tumor-targeting intervention that were published in The Lancet, The Lancet Oncology, JAMA, JAMA Oncology, Journal of Clinical Oncology, and The New England Journal of Medicine between May 1, 2021, and May 1, 2022.ExposuresAssistance of medical writers or no assistance.Main Outcomes and MeasuresThe main outcomes were the percentage of studies with medical writers, the percentage of trial successes reported with medical writers, the association between trial success and medical writer use, and the association between a primary end point and medical writer use.ResultsAmong 270 studies, 141 (52.2%) included a medical writer and 129 (47.8%) did not include a medical writer. Of the studies that included a medical writer, 83 (58.9%) were successful. Of the studies that did not include a medical writer, 64 (49.6%) were successful (P = .16 for difference). Studies with medical writers were less likely than studies without medical writers to have the end point of overall survival (15 [10.6%] vs 17 [13.2%]) and disease-free or event-free survival (16 [11.3%] vs 29 [22.5%]), whereas studies with a medical writer were more likely to have the end point of progression-free survival (32 [22.7%] vs 17 [13.2%]). Use of medical writer was associated with the conclusions being presented favorably in all studies (113 [80.1%] vs 89 [69.0%]; odds ratio [OR], 1.81 [95% CI, 1.04-3.19]), but when adjusted for other variables, there was no association (OR, 1.84 [95% CI, 0.92-3.72]).Conclusions and RelevanceIn this cross-sectional study, trials using medical writers were more likely to report surrogate end points, such as progression-free survival, and favorable conclusions, but when adjusted for trial phase, randomization, and study funding, there was no association with favorable conclusions. These findings suggest that journals need heightened scrutiny for studies with medical writers and that authorship should be properly acknowledged.

Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma

“…Future trials can help address this problem by consistently reporting PROs, describing toxic effects objectively as they occur, and avoiding overemphasis of AE attribution and use of minimizing terms. Education for medical writers, who are often employed to draft reports of industry-sponsored trials, may help to curb overuse of minimizing terms …”

“…Education for medical writers, who are often employed to draft reports of industry-sponsored trials, may help to curb overuse of minimizing terms. 78 …”

“…10 Compared with investigator assessments, PROs allow patients to decide whether they consider a treatment safe or tolerable. Given that AEs tend to be underreported by clinicians compared with patients, 77 we must ask our patients if we really want to know the true 78 Examples of studies in which toxic effects were described without minimizing terms include trials of daratumumab and elotuzumab. For example, investigators in 1 study transparently reported that daratumumab use was associated with infusion-related reactions and a higher rate of neutropenia than the control therapy, instead of using minimizing terms.…”