We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Frequency and Characteristics of Trials Using Medical Writer Support in High-Impact Oncology Journals.
- Authors
Buck, Eva; Haslam, Alyson; Tuia, Jordan; Prasad, Vinay
- Abstract
This cross-sectional study reviews original oncology trials to assess whether the declared use of medical writers is associated with trial success and the use of a particular type of end point. Key Points: Question: What are the characteristics of cancer studies that use and do not use medical writer support? Findings: In this cross-sectional analysis of 270 clinical trials, compared with studies that did not use medical writers, studies with medical writers were more likely to focus on progression-free survival than overall survival and were more likely to report favorable conclusions, but there was no association with favorable conclusions in the adjusted analysis. Meaning: These findings suggest that the use of medical writers is associated with the end point of progression-free survival. Importance: The practice of using medical writers to communicate scientific information has gained popularity, but it may affect how and what information is communicated. Objective: To 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 Participants: This 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. Exposures: Assistance of medical writers or no assistance. Main Outcomes and Measures: The 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. Results: Among 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 Relevance: In 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.
- Subjects
BLADDER tumors; RENAL cell carcinoma; CLINICAL trials; CONFIDENCE intervals; CROSS-sectional method; MANN Whitney U Test; LUNG tumors; HEAD &; neck cancer; DESCRIPTIVE statistics; QUALITY of life; CHI-squared test; RESEARCH funding; HEMATOLOGIC malignancies; KIDNEY tumors; MEDICAL writing; ODDS ratio; PROGRESSION-free survival; LOGISTIC regression analysis; STATISTICAL models; DATA analysis software; ONCOLOGY; OVERALL survival; BREAST tumors
- Publication
JAMA Network Open, 2023, Vol 6, Issue 1, pe2254405
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2022.54405