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The Future Glioblastoma Clinical Trials Landscape: Early Phase 0, Window of Opportunity, and Adaptive Phase I–III Studies
Purpose of ReviewInnovative clinical trial designs for glioblastoma (GBM) are needed to expedite drug discovery. Phase 0, window of opportunity, and...
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Do Early Phase Oncology Trials Predict Clinical Efficacy in Subsequent Biomarker-Enriched Phase III Randomized Trials?
BackgroundPromising early phase trial results of biomarker-targeted therapies have occasionally led to regulatory approval.
Objective ...
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Antiangiogenic–immune-checkpoint inhibitor combinations: lessons from phase III clinical trials
Antiangiogenic agents, generally antibodies or tyrosine-kinase inhibitors that target the VEGF–VEGFR pathway, are currently among the few combination...
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Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase 3 Trials
Tapinarof cream 1% (VTAMA ® ; Dermavant Sciences, Inc.) is a non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the US Food and Drug...
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Tralokinumab Efficacy Over 1 Year in Adults with Moderate-to-Severe Atopic Dermatitis: Pooled Data from Two Phase III Trials
BackgroundTwo phase III trials, ECZTRA 1 and 2, confirmed the efficacy and safety of tralokinumab versus placebo in adults with moderate-to-severe...
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Use of Varied Screening Risk Criteria and HIV Incidence in Phase 1 and 2 HIV Vaccine Trials in South Africa
Many early phase HIV prevention studies define HIV risk-related eligibility criteria. We conducted a retrospective review of HIV Vaccine Trials...
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Establishing Optimal Control Cohorts for Phase 1 Trials: Retrospective Analysis of Clinical and Biological Outcomes in Neonates and Infants Undergoing Two-Ventricle Repair
Phase 1 trials are primarily conducted to evaluate the safety and feasibility of new interventions, usually without recruiting control patients. This...
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Rapid Improvements in Itch with Tapinarof Cream 1% Once Daily in Two Phase 3 Trials in Adults with Mild to Severe Plaque Psoriasis
IntroductionPatients with psoriasis report pruritus as their most bothersome symptom. Tapinarof cream 1% once daily demonstrated significant efficacy...
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Evolving or immutable - phase I solid tumor trials in the era of precision oncology
In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted...
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Seamless phase 2/3 design for trials with multiple co-primary endpoints using Bayesian predictive power
Seamless phase 2/3 design has become increasingly popular in clinical trials with a single endpoint. Trials that define success based on the...
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Adaptive designs were primarily used but inadequately reported in early phase drug trials
BackgroundFaced with the high cost and limited efficiency of classical randomized controlled trials, researchers are increasingly applying adaptive...
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Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase 3 Clinical Trials (Measure Up 1 and 2)
IntroductionAtopic dermatitis (AD) is characterized by intense itch and other symptoms that negatively impact quality of life (QoL). This study...
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Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units
BackgroundLate-phase platform protocols (including basket, umbrella, multi-arm multi-stage (MAMS), and master protocols) are generally agreed to be...
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Evaluation of supportive care needs, sexuality and quality of life in phase 1 trials: a prospective monocentric study
PurposePatients enrolled in oncology phase 1 trials (ph1) usually have advanced heavily pre-treated cancers with few therapeutic options. Quality of...
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Overall survival in the SIMPLIFY-1 and SIMPLIFY-2 phase 3 trials of momelotinib in patients with myelofibrosis
Janus kinase inhibitors (JAKi) approved for myelofibrosis provide spleen and symptom improvements but do not address anemia, a negative prognostic...
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Immunity in digestive diseases: new drugs for inflammatory bowel disease treatment—insights from Phase II and III trials
BackgroundInflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), continues to challenge treatment...
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Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences
BackgroundPhase 1 drug trials are popular treatment options for patients with advanced disease, despite the greater levels of uncertainty associated...
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Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention
BackgroundPatients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical...
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A flexible dose-response modeling framework based on continuous toxicity outcomes in phase I cancer clinical trials
BackgroundThe past few decades have seen remarkable developments in dose-finding designs for phase I cancer clinical trials. While many of these...
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Reporting of PPI and the MCID in phase III/IV randomised controlled trials—a systematic review
BackgroundPatient and public involvement (PPI) in clinical trial design contributes to ensuring the research objectives and outcome measures are...
