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Mobile technologies offer the potential to reduce the costs of conducting clinical trials by collecting high-quality information on health outcomes in real-world settings that are relevant to patients and clinicians. However, widespread use of mobile technologies in clinical trials has been impeded by their perceived challenges. To advance solutions to these challenges, the Clinical Trials Transformation Initiative (CTTI) has issued best practices and realistic approaches that clinical trial sponsors can now use. These include CTTI recommendations on technology selection; data collection, analysis, and interpretation; data management; protocol design and execution; and US Food and Drug Administration submission and inspection. The scientific principles underpinning the clinical trials enterprise continue to apply to studies using mobile technologies. These recommendations provide a framework for including mobile technologies in clinical trials that can lead to more efficient assessment of new therapies for patients.
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http://dx.doi.org/10.1159/000503957 | DOI Listing |
Infect Dis Ther
September 2025
School of Biomedical Sciences, The Chinese University of Hong Kong (CUHK), Hong Kong SAR, China.
Introduction: The high mortality of Coronavirus Disease 2019 (COVID-19) highlights the need for safe and effective antiviral treatment. Small molecular antivirals (remdesivir, molnupiravir, nirmatrelvir/ritonavir) and immunomodulators (baricitinib, tocilizumab) have been developed or repurposed to suppress viral replication and ameliorate cytokine storms, respectively. Despite U.
View Article and Find Full Text PDFJ Neurooncol
September 2025
Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.
Purpose: Patients diagnosed with high-grade gliomas (HGG) often experience substantial psychosocial dis-tress. However, due to neurological and neurocognitive deficits its assessment remains challenging, and needs remain unmet. We compared a novel face-to-face assessment during doctor-patient conversations with questionnaire-based screening.
View Article and Find Full Text PDFCancer Immunol Immunother
September 2025
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Whole blood (WB) transcriptomics offers a minimal-invasive method to assess patients' immune system. This study aimed to identify transcriptional patterns in WB associated with clinical outcomes in patients treated with immune checkpoint inhibitors (ICIs). We performed RNA-sequencing on pre-treatment WB samples from 145 patients with advanced cancer.
View Article and Find Full Text PDFNat Genet
September 2025
Cancer Research UK Lung Cancer Centre of Excellence, University College London Cancer Institute, London, UK.
Aberrant DNA methylation has been described in nearly all human cancers, yet its interplay with genomic alterations during tumor evolution is poorly understood. To explore this, we performed reduced representation bisulfite sequencing on 217 tumor and matched normal regions from 59 patients with non-small cell lung cancer from the TRACERx study to deconvolve tumor methylation. We developed two metrics for integrative evolutionary analysis with DNA and RNA sequencing data.
View Article and Find Full Text PDFNat Rev Neurol
September 2025
Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.
Health disparities are preventable differences in health between different populations, and they are endemic throughout medicine owing to social, economic and environmental disadvantages. Neurology is no exception, and health disparities for systematically marginalized groups are present in the prevention, diagnosis, treatment and outcomes of all neurological disorders. The aetiology of these disparities is complex and multifactorial, reflecting the interplay of structural, institutional and individual-level factors.
View Article and Find Full Text PDF