Optimizing interim analysis timing for Bayesian adaptive commensurate designs.
Sign Up to like & getrecommendations! Published in 2019 at "Statistics in medicine"
DOI: 10.1002/sim.8414
Abstract: In developing products for rare diseases, statistical challenges arise due to the limited number of patients available for participation in drug trials and other clinical research. Bayesian adaptive clinical trial designs offer the possibility of… read more here.
Keywords: interim analysis; bayesian adaptive; optimizing interim; adaptive commensurate ... See more keywords
Group sequential methods for interim monitoring of randomized clinical trials with time‐lagged outcome
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DOI: 10.1002/sim.9580
Abstract: The primary analysis in two‐arm clinical trials usually involves inference on a scalar treatment effect parameter; for example, depending on the outcome, the difference of treatment‐specific means, risk difference, risk ratio, or odds ratio. Most… read more here.
Keywords: time; clinical trials; interim analysis; trials time ... See more keywords
Modified Reduced Intensity Conditioning (RIC) of HLA-Haploidentical Related Hematopoietic Cell Transplantation (HAPLO-HCT) for Patients with Hematological Malignancies: Interim Analysis of an Age- and Risk-Adapted Phase II Trial
Sign Up to like & getrecommendations! Published in 2019 at "Biology of Blood and Marrow Transplantation"
DOI: 10.1016/j.bbmt.2018.12.784
Abstract: Use of full intensity conditioning regimens with haplo-HCT in younger patients lowered the risk of relapse; however, this is often not an option especially for older patients and for those with higher comorbidities due to… read more here.
Keywords: haplo hct; interim analysis; age; risk ... See more keywords
Characteristics of Patients with Hereditary Transthyretin Amyloidosis and an Evaluation of the Safety of Tafamidis Meglumine in Japan: An Interim Analysis of an All-case Postmarketing Surveillance.
Sign Up to like & getrecommendations! Published in 2020 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2020.07.001
Abstract: PURPOSE An all-case, single-arm, observational, postmarketing surveillance is underway to assess the safety of tafamidis in patients with hereditary transthyretin (ATTRv) amyloidosis with peripheral polyneuropathy, also called transthyretin-type familial amyloid polyneuropathy, in Japan. Results from… read more here.
Keywords: safety; interim analysis; case; amyloidosis ... See more keywords
Withania somnifera as a safer option to hydroxychloroquine in the chemoprophylaxis of COVID-19: Results of interim analysis
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DOI: 10.1016/j.ctim.2021.102768
Abstract: Objectives To study the efficacy and safety of Withania somnifera (WS) in the prophylaxis against COVID-19 in high risk health care workers (HCW) in comparison to hydroxychloroquine (HCQ). To evaluate general physical and mental health… read more here.
Keywords: withania somnifera; hcq; safer option; interim analysis ... See more keywords
Effects of adding L-arginine orally to standard therapy in patients with COVID-19: A randomized, double-blind, placebo-controlled, parallel-group trial. Results of the first interim analysis
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DOI: 10.1016/j.eclinm.2021.101125
Abstract: Background We and others have previously demonstrated that the endothelium is a primary target of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and L-arginine has been shown to improve endothelial dysfunction. However, the effects… read more here.
Keywords: trial; parallel group; interim analysis; group ... See more keywords
Effectiveness and tolerability of adjunctive brivaracetam in patients with focal seizures: Second interim analysis of 6-month data from a prospective observational study in Europe
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DOI: 10.1016/j.eplepsyres.2020.106329
Abstract: Brivaracetam (BRV) is indicated for adjunctive treatment of focal (partial-onset) seizures with or without secondary generalisation in patients 4 years of age and older in the European Union (EU). An ongoing 12-month, prospective, non-interventional post-marketing… read more here.
Keywords: treatment; interim analysis; study; focal seizures ... See more keywords
Efficacy and safety of avapritinib in advanced systemic mastocytosis: interim analysis of the phase 2 PATHFINDER trial
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DOI: 10.1038/s41591-021-01539-8
Abstract: Advanced systemic mastocytosis (AdvSM) is a rare, KIT D816V-driven hematologic neoplasm characterized by mast cell infiltration and shortened survival. We report the results of a prespecified interim analysis of an ongoing pivotal single-arm phase 2 trial… read more here.
Keywords: response; systemic mastocytosis; interim analysis; advanced systemic ... See more keywords
Robust time selection for interim analysis in the Bayesian phase 2 exploratory clinical trial.
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DOI: 10.1080/10543406.2023.2208665
Abstract: In phase 2 clinical trials, we expect to make a right Go or No-Go decision during the interim analysis (IA) and make this decision at the right time. The optimal time for IA is usually… read more here.
Keywords: time; exploratory clinical; interim analysis; phase ... See more keywords
MO039THE 24-WEEK INTERIM ANALYSIS RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF ATACICEPT IN PATIENTS WITH IGA NEPHROPATHY AND PERSISTENT PROTEINURIA
Sign Up to like & getrecommendations! Published in 2020 at "Nephrology Dialysis Transplantation"
DOI: 10.1093/ndt/gfaa140.mo039
Abstract: IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world. Despite being described over 50 years ago, there remains no approved therapy for this common global cause of kidney failure. The central pathogenic… read more here.
Keywords: week; week interim; iga1; interim analysis ... See more keywords
P0890EFFICACY AND SAFETY OF CINACALCET IN CHINESE MAINTENANCE HEMODIALYSIS PATIENTS WITH DIFFERENT STAGES OF SECONDARY HYPERPARATHYROIDISM: INTERIM ANALYSIS RESULTS OF ACTIVE STUDY
Sign Up to like & getrecommendations! Published in 2020 at "Nephrology Dialysis Transplantation"
DOI: 10.1093/ndt/gfaa142.p0890
Abstract: Chronic kidney disease (CKD) is a major public health issue worldwide including in China. One of the most common complication in advanced Chronic kidney disease (CKD) is secondary hyperparathyroidism (SHPT). Reports show higher risk of… read more here.
Keywords: analysis; safety; interim analysis; study ... See more keywords