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A comparison of clinical development pathways to advance tuberculosis regimen development
BackgroundCurrent tuberculosis (TB) regimen development pathways are slow and in urgent need of innovation. We investigated novel phase IIc and...
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New clinical trial design in precision medicine: discovery, development and direction
In the era of precision medicine, it has been increasingly recognized that individuals with a certain disease are complex and different from each...
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Clinical development of mRNA therapies against solid tumors
The mRNA-based therapeutics have become the hot spot of biopharmaceutical industries in recent years. The landscape of this area is expanding from...
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Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development
BackgroundRitlecitinib is an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor undergoing parallel clinical...
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Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities
Immunotherapy represented by anti-PD-(L)1 and anti-CTLA-4 inhibitors has revolutionized cancer treatment, but challenges related to resistance and...
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Considerations for the design of antibody drug conjugates (ADCs) for clinical development: lessons learned
Antibody–drug conjugates (ADCs) have emerged as a novel therapeutic strategy that has successfully reached patient treatment in different clinical...
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AXL Inhibitors: Status of Clinical Development
Purpose of ReviewThe AXL signaling pathway is associated with tumor growth as well as poor prognosis in cancer. Here, we highlight recent strategies...
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Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians
BackgroundStatisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency,...
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Alzheimer’s Disease: Combination Therapies and Clinical Trials for Combination Therapy Development
Alzheimer’s disease (AD) is a complex multifaceted disease. Recently approved anti-amyloid monoclonal antibodies slow disease progression by...
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Innovative thinking of clinical investigation for rare disease drug development
For the development of a test treatment or drug product, it is necessary to conduct composite hypothesis testing to test for effectiveness and safety...
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The development of a framework for clinical education programme of undergraduate nursing students in Ghana
IntroductionClinical education is an important aspect of the training of nursing students but it is faced with challenges in Ghana. The development...
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Development of an integrated and comprehensive clinical trial process management system
BackgroundThe process of initiating and completing clinical drug trials in hospital settings is highly complex, with numerous institutional,...
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Perinatal compromise affects development, form, and function of the hippocampus part one; clinical studies
AbstractThe hippocampus is a neuron-rich specialised brain structure that plays a central role in the regulation of emotions, learning and memory,...
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Simulation-based development: sha** clinical procedures for extra-uterine life support technology
BackgroundResearch into Artificial Placenta and Artificial Womb (APAW) technology for extremely premature infants (born < 28 weeks of gestation) is...
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Novel neurosteroid therapeutics for post-partum depression: perspectives on clinical trials, program development, active research, and future directions
This article reviews novel neurosteroid therapeutics for post-partum depression, with a focus on their development, clinical trial data, current...
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Study methodology and insights from the palovarotene clinical development program in fibrodysplasia ossificans progressiva
BackgroundThe design of clinical trials in rare diseases is often complicated by a lack of real-world translational knowledge. Fibrodysplasia...
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Recent Advancements in the Therapeutic Development for Marburg Virus: Updates on Clinical Trials
Purpose of ReviewWe aim to provide valuable insights into the current state of therapeutic development for the deadly Marburg virus and guide...
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Development and Validation of a Machine Learning Algorithm Using Clinical Pages to Predict Imminent Clinical Deterioration
BackgroundEarly detection of clinical deterioration among hospitalized patients is a clinical priority for patient safety and quality of care....
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Development of a novel observed structured clinical exam to assess clinical ultrasound proficiency in undergraduate medical education
ObjectivesA pilot study was performed to develop and test an observed structured clinical exam (OSCE) for clinical ultrasound in second-year medical...
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Impact of anti-VEGF treatment on development of proliferative diabetic retinopathy in routine clinical practice
BackgroundThis study evaluated impact of anti–vascular endothelial growth factor (VEGF) treatment on proliferative diabetic retinopathy (PDR)...
