Associations between safety, tolerability, and toxicity and the reporting of health‐related quality of life in phase III randomized trials in common solid tumors
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DOI: 10.1002/cam4.3390
Abstract: Anti‐cancer drugs are approved typically on the basis of efficacy and safety as evaluated in phase III randomized trials (RCTs). Health‐related quality of life (HRQoL) is a direct measure of patient benefit, but is under‐reported.… read more here.
Keywords: phase; health related; iii randomized; phase iii ... See more keywords
Health‐related quality of life in stage III‐IV melanoma treated with targeted therapy or immunotherapy: A systematic review on the adequacy of reporting and clinical issues in phase III randomized controlled trials
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DOI: 10.1002/cam4.5183
Abstract: Cutaneous melanoma represents around over 90% of all melanoma. With more effective treatments able to extend patients' survival, health‐related quality of life (HRQOL) is increasingly becoming an important endpoint in cancer clinical trials. They are… read more here.
Keywords: iii randomized; randomized controlled; controlled trials; hrqol ... See more keywords
Disease Modeling and Model‐Based Meta‐Analyses to Define a New Direction for a Phase III Program of Gantenerumab in Alzheimer’s Disease
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DOI: 10.1002/cpt.2535
Abstract: Selecting the right dose is a significant challenge in designing clinical development programs, especially for slowly progressing diseases lacking predictive biomarkers of efficacy that may require long‐term treatment to assess clinical benefit. Gantenerumab, a fully… read more here.
Keywords: gantenerumab; alzheimer disease; model; phase ... See more keywords
Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies
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DOI: 10.1002/cpt.2601
Abstract: Tofacitinib is an oral small molecule JAK inhibitor for the treatment of ulcerative colitis. Relationships between plasma tofacitinib concentration and efficacy were characterized using exposure‐response (E‐R) models, with demographic and disease covariates evaluated as potential… read more here.
Keywords: maintenance; tofacitinib; efficacy; phase iii ... See more keywords
Reporting real‐life experience with drugs in lymphoma patients
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DOI: 10.1002/hon.2284
Abstract: Carrying out clinical trials and reporting on these studies are essential requisites for drug development and approval. Phase IV studies are essential for the continuing monitoring of drugs. The differences are fundamental: the efficacy of… read more here.
Keywords: phase; drug; phase iii; real life ... See more keywords
ROBUST: PHASE III RANDOMIZED STUDY OF LENALIDOMIDE/R‐CHOP VS PLACEBO/R‐CHOP IN UNTREATED ABC‐TYPE DIFFUSE LARGE B‐CELL LYMPHOMA AND FEASIBILITY OF CELL OF ORIGIN SUBTYPING
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DOI: 10.1002/hon.2440
Abstract: OT01 ROBUST: PHASE III RANDOMIZED STUDY OF LENALIDOMIDE/R‐CHOP VS PLACEBO/ R‐CHOP IN UNTREATED ABC‐TYPE DIFFUSE LARGE B‐CELL LYMPHOMA AND FEASIBILITY OF CELL OF ORIGIN SUBTYPING A. Chiappella* | T.E. Witzig | U. Vitolo | R.… read more here.
Keywords: cell; hematology; oncology; phase iii ... See more keywords
Basal biomarkers nestin and INPP4B predict gemcitabine benefit in metastatic breast cancer: Samples from the phase III SBG0102 clinical trial
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DOI: 10.1002/ijc.31969
Abstract: In a formal prospective‐retrospective analysis of the phase III SBG0102 clinical trial randomizing metastatic breast cancer patients to gemcitabine‐docetaxel or to single agent docetaxel, patients with basal‐like tumors by PAM50 gene expression had significantly better… read more here.
Keywords: basal; phase iii; nestin inpp4b; breast cancer ... See more keywords
Reply to: Comments on “Effect of HIPEC according to HRD/BRCAwt genomic profile in stage III ovarian cancer: Results from the phase III OVHIPEC trial”
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DOI: 10.1002/ijc.34219
Abstract: “ Effect of HIPEC according to HRD/ BRCA wt genomic profile in stage III ovarian cancer: Results from the phase III OVHIPEC trial. In our study, we performed post hoc exploratory analysis of the effect… read more here.
Keywords: effect; hipec according; profile; hipec ... See more keywords
Phase III randomized clinical trial of BV‐4051, an Ayurvedic polyherbal formulation in moderate SARS‐CoV‐2 infections and its impact on inflammatory biomarkers
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DOI: 10.1002/ptr.7683
Abstract: SARS‐CoV‐2 virus and its variants continue to be a challenge inspite of widespread vaccination and preventive measures. We hypothesized an oral, safe polyherbal formulation with antiinflammatory properties may improve the clinical outcome of this disease.… read more here.
Keywords: iii randomized; formulation; phase iii; polyherbal formulation ... See more keywords
Design of phase III trials with long-term survival outcomes based on short-term binary results.
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DOI: 10.1002/sim.9018
Abstract: Pathologic complete response (pCR) is a common primary endpoint for a phase II trial or even accelerated approval of neoadjuvant cancer therapy. If granted, a two-arm confirmatory trial is often required to demonstrate the efficacy… read more here.
Keywords: iii trials; phase iii; term; survival ... See more keywords
[Alzheimer's disease-Which substances are at present in phase III studies?]
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DOI: 10.1007/s00115-022-01275-5
Abstract: BACKGROUND The recent approval of aduhelm/aducanumab by the US Food and Drug Administration (FDA) in June 2021 raised hopes that further substances against Alzheimer's disease might be approved in the near future. OBJECTIVE The current… read more here.
Keywords: iii studies; phase iii; alzheimer disease; disease ... See more keywords