In this paper, we describe developments in adaptive design methodology and discuss implementation strategies and operational challenges in early phase adaptive clinical trials. The BATTLE trial - the first completed, biomarker-based, Bayesian adaptive randomized study in lung cancer - is presented as a case study to illustrate main ideas and share learnings.
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http://dx.doi.org/10.1177/2168479013513889 | DOI Listing |
J Med Internet Res
January 2025
Knight Foundation of Computing & Information Sciences, Florida International University, Miami, FL, United States.
Background: Digital biomarkers are increasingly used in clinical decision support for various health conditions. Speech features as digital biomarkers can offer insights into underlying physiological processes due to the complexity of speech production. This process involves respiration, phonation, articulation, and resonance, all of which rely on specific motor systems for the preparation and execution of speech.
View Article and Find Full Text PDFPhys Eng Sci Med
January 2025
School of Physics, Mathematics and Computing, The University of Western Australia, Crawley, WA, Australia.
Artificial Intelligence (AI) based auto-segmentation has demonstrated numerous benefits to clinical radiotherapy workflows. However, the rapidly changing regulatory, research, and market environment presents challenges around selecting and evaluating the most suitable solution. To support the clinical adoption of AI auto-segmentation systems, Selection Criteria recommendations were developed to enable a holistic evaluation of vendors, considering not only raw performance but associated risks uniquely related to the clinical deployment of AI.
View Article and Find Full Text PDFRheumatol Int
January 2025
Department of Internal Medicine & Office of Research, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
We aimed to assess the typical experiences, desired outcomes, satisfaction with clinical and anticipated outcomes, and the importance of improvements for individuals with Hypermobile Ehlers-Danlos Syndrome (hEDS) and Generalized Hypermobility Spectrum Disorder (G-HSD). A cross-sectional survey was conducted among adults aged 18 and above with hEDS and G-HSD. The survey included the Patient-Centered Outcome Questionnaire and an adapted version addressing common concerns in these individuals.
View Article and Find Full Text PDFJ Sports Med Phys Fitness
January 2025
Unit of Cardiovascular Sciences, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Endurance sports have witnessed an increase in female participation, demanding a constant and evolving reassessment of the specific physiological and health implications of female athletes. In the present review, we analyze cardiovascular, hematological adaptations and anthropometry and hormonal fluctuations highlighting sex-specific differences in response to exercise, with estrogen playing a fundamental role in modulating body composition and metabolic processes. Nutritional aspects, in particular energy availability, macronutrient distribution and hydration, are fundamental in supporting training demands and menstrual function.
View Article and Find Full Text PDFJ Crohns Colitis
January 2025
Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Background And Aims: Treating ulcerative colitis (UC) in patients with prior advanced therapy (AT) exposure may be challenging. We report the efficacy and safety of risankizumab, a monoclonal interleukin 23p19 antibody, in patients with UC and prior inadequate response or intolerance to AT (AT-IR).
Methods: In the 12-week phase 3 INSPIRE induction study, patients were randomized to intravenous risankizumab 1200 mg or placebo.
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