Ther Innov Regul Sci
December 2024
Since 2019, the Association of Clinical Research Organizations has conducted a landscape survey of risk based quality management (RBQM) adoption in clinical trials. Here, we present data from four years of surveys, with an emphasis on the most recent: the 2022 survey included data from 4958 trials across seven contract research organizations, of which 1004 were new studies started in 2022. Results indicate that while overall risk assessment adoption is strong, it is lagging in other risk-based components which suggests companies are not deriving the full expected benefits of performing a risk assessment and mitigation process to their trials.
View Article and Find Full Text PDFArticle processing charges are increasingly being levied on authors via publication fees to provide open access to readers. These charges may impose challenges to early career physicians seeking to publish research but pathology journal article processing charges have not been investigated to date. We aimed to quantify pathology journal article processing charges and investigate the potential associated factors.
View Article and Find Full Text PDFBreast lymphedema is a common sequela of breast conservation that delays healing and reduces quality of life. No rigorous classification system exists for this condition. We explored approaches for classifying breast lymph-edema based on breast ultrasound, physical exam, and patient-reported outcomes.
View Article and Find Full Text PDFBackground: There is limited data examining potential disparities in the receipt of immunotherapy among patients with stage III melanoma.
Methods: We performed a retrospective cohort review using the National Cancer Database (NCDB) including adult patients with stage III melanoma between 2004 and 2017. We compared receipt of immunotherapy based on demographic and socioeconomic factors for patients diagnosed 2004-2014 and 2016-2017, before and after FDA approval of immune checkpoint blockade.