The main objective of a confirmatory multiregional clinical trial (MRCT) is to demonstrate the overall efficacy of test drugs in all participating regions as well as to evaluate the possibility of extrapolating the overall results to each region. With the emergence of the demands of biosimilar drugs development, some guidelines recommended using equivalence design to demonstrate the comparability of efficacy between biosimilar and reference drugs. Previous discussions about assessing regional consistency in MRCT are mainly focused on superiority or non-inferiority designs, while the extensions to equivalence designs were limited. In this work, we proposed a flexible regional consistency criterion for the MRCT with equivalence design. Based on this criterion, sample size determination and sample allocation were also discussed.
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http://dx.doi.org/10.1002/pst.2044 | DOI Listing |
J Int AIDS Soc
January 2025
Melbourne Sexual Health Centre, Alfred Health, Melbourne, Victoria, Australia.
Introduction: The World Health Organization (WHO) recommends the use of antiretroviral drugs as post-exposure prophylaxis (PEP) for preventing HIV acquisition for occupational and non-occupational exposures. To inform the development of global WHO recommendations on PEP, we reviewed national guidelines of PEP for their recommendations.
Methods: Policies addressing PEP from 38 WHO HIV priority countries were obtained by searching governmental and non-governmental websites and consulting country and regional experts; these countries were selected based on HIV burden, new HIV acquisitions and the number of HIV-associated deaths.
Front Immunol
January 2025
Department of Pathology, Microbiology & Immunology, New York Medical College, Valhalla, NY, United States.
Rationale: Approximately 32 million people in the United States suffer from food allergies. Some food groups, such as legumes - peanuts, tree nuts, fish, and shellfish, have a high risk of cross-reactivity. However, the murine model of multiple food group cross-reactivity is limited.
View Article and Find Full Text PDFFront Med (Lausanne)
January 2025
Department of Law, Institute of Legal Medicine, University of Macerata, Macerata, Italy.
Introduction: Adverse events in hospitals significantly compromise patient safety and trust in healthcare systems, with medical errors being a leading cause of death globally. Despite efforts to reduce these errors, reporting remains low, and effective system changes are rare. This systematic review explores the potential of artificial intelligence (AI) in clinical risk management.
View Article and Find Full Text PDFFront Pharmacol
January 2025
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
Introduction: radix et rhizoma (Danshen) is a crucial medicinal material for treating cardiovascular and cerebrovascular diseases. However, the presence of adulterants and intraspecific variability poses challenges to its clinical safety.
Methods: This study collected samples of from various regions and commonly encountered adulterants.
Open Life Sci
December 2024
Department of Pathology, Hangzhou Women's Hospital, 369 Kunpeng Road, Shangcheng District, Hangzhou, 310008, Zhejiang, China.
Breast cancer is a common malignant tumor of women. Ki67 is an important biomarker of cell proliferation. With the quantitative analysis, it is an important indicator of malignancy for breast cancer diagnosis.
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