Professional Medical Writer Assistance in Oncology Clinical Trials.
Oncologist
; 25(11): e1812-e1815, 2020 11.
Article
em En
| MEDLINE
| ID: mdl-32885898
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 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.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Escrita Médica
/
Neoplasias
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Oncologist
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos