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http://dx.doi.org/10.1186/s12874-025-02502-8 | DOI Listing |
Biom J
October 2025
Novella Clinical Full Service, IQVIA, Melbourne, Australia.
Phase I dose escalation trials in oncology generally aim to find the maximum tolerated dose. However, with the advent of molecular-targeted therapies and antibody drug conjugates, dose-limiting toxicities are less frequently observed, giving rise to the concept of optimal biological dose (OBD), which considers both efficacy and toxicity. The estimand framework presented in the addendum of the ICH E9(R1) guidelines strengthens the dialogue between different stakeholders by bringing in greater clarity in the clinical trial objectives and by providing alignment between the targeted estimand under consideration and the statistical analysis methods.
View Article and Find Full Text PDFBMC Cancer
September 2025
Department of Gastrointestinal Surgery, Affiliated Hospital of Chengde Medical University, No. 36 Nanyingzi Street, Chengde, Hebei, 067000, China.
Parasit Vectors
September 2025
School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
BMC Psychiatry
September 2025
Department of Cardiovascular, The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Jiangxi, Nanchang, 330006, China.
J Behav Health Serv Res
September 2025
Adolescent Behavioral Health Research Program, Indiana University School of Medicine, Indianapolis, IN, USA.
Evidence-based practices (EBPs) are most effective when they are delivered with a high degree of fidelity, or as they are intended to be delivered. Because clinicians often deviate from fidelity, it is important to monitor EBP fidelity over time to guide corrective actions. However, little is known about current fidelity monitoring practices in community behavioral health care.
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