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Relevant bibliographies by topics / Bayesian statistics, meta-analysis, phase I dose-escalation trials

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Academic literature on the topic 'Bayesian statistics, meta-analysis, phase I dose-escalation trials'

Author: Grafiati

Published: 4 June 2021

Last updated: 6 February 2022

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Journal articles on the topic "Bayesian statistics, meta-analysis, phase I dose-escalation trials"

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Brard, Caroline, Gwénaël Le Teuff, Marie-Cécile Le Deley, and Lisa V. Hampson. "Bayesian survival analysis in clinical trials: What methods are used in practice?" Clinical Trials 14, no. 1 (2016): 78–87. http://dx.doi.org/10.1177/1740774516673362.

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Background Bayesian statistics are an appealing alternative to the traditional frequentist approach to designing, analysing, and reporting of clinical trials, especially in rare diseases. Time-to-event endpoints are widely used in many medical fields. There are additional complexities to designing Bayesian survival trials which arise from the need to specify a model for the survival distribution. The objective of this article was to critically review the use and reporting of Bayesian methods in survival trials. Methods A systematic review of clinical trials using Bayesian survival analyses was

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Zheng, Haiyan, Lisa V. Hampson, and Simon Wandel. "A robust Bayesian meta-analytic approach to incorporate animal data into phase I oncology trials." Statistical Methods in Medical Research 29, no. 1 (2019): 94–110. http://dx.doi.org/10.1177/0962280218820040.

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Before a first-in-man trial is conducted, preclinical studies are performed in animals to help characterise the safety profile of the new medicine. We propose a robust Bayesian hierarchical model to synthesise animal and human toxicity data, using scaling factors to translate doses administered to different animal species onto an equivalent human scale. After scaling doses, the parameters of dose-toxicity models intrinsic to different animal species can be interpreted on a common scale. A prior distribution is specified for each translation factor to capture uncertainty about differences betwe

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O'Kane, Grainne M., Jennifer L. Spratlin, Petr Kavan, et al. "BOLD-100-001 (TRIO039): A phase Ib dose-escalation study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastrointestinal solid tumors." Journal of Clinical Oncology 39, no. 3_suppl (2021): TPS145. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.tps145.

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TPS145 Background: Although most cancers are initially susceptible to existing anticancer therapies, over time cancer cells develop resistance. BOLD-100 is a first-in-class therapy that targets the GRP78 pathway, a major regulator of cellular stress and resistance. This therapy suppresses drug resistance, survival and proliferation by restraining stress-induced upregulation of GRP78 in tumor cells, leading to inhibition of the cell survival response. BOLD-100 successfully completed a Phase 1 monotherapy trial, with a manageable safety profile; it has demonstrated synergy in established preclin

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Maurer, W. "Creative and Innovative Statistics in Clinical Research and Development." Methods of Information in Medicine 44, no. 04 (2005): 551–60. http://dx.doi.org/10.1055/s-0038-1634007.

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Summary Objectives: The aim of this paper is to show that even in a highly regulated area such as clinical research and development in pharmaceutical industry, there are needs and ample opportunities for statisticians and other medical informatics professionals to further creatively develop and implement methods in order to support the collection, analysis and interpretation of clinical data. Methods: The recently published “Critical Path” initiative of the US Food and Drug Administration discusses the decline in new drug submissions in the last decade and illustrates potential causes in the p

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Sarangarajan, Rangaprasad, Vivek Subbiah, David S. Hong, et al. "Bayesian AI to delineate molecular signatures of patient susceptibility to potential hematologic events in a phase I study of BPM31510 (ubidecarenone) in solid tumors." Journal of Clinical Oncology 35, no. 15_suppl (2017): e14042-e14042. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e14042.

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e14042 Background: BPM 31510 is a ubidecarenone containing nanodispersion elicits anticancer effect by switching cancer cells energy generation from glycolysis to mitochondrial OXPHOS; i.e. reverses Warburg effect. This Phase 1 study is evaluating safety of 144-hour infusion of BPM 31510 as a single agent and in combination with 3 standard chemotherapy regimens. The molecular adaptive study design enabled longitudinal multi-omic molecular profiling to delineate personalized cause-and-effect networks relating patient biology to clinical outcomes using unbiased Bayesian statistics based bAIcis A

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Copland, Mhairi, Daniel Slade, Jenny Byrne, et al. "FLAG-IDA and Ponatinib in Patients with Blast Phase Chronic Myeloid Leukaemia: Results from the Phase I/II UK Trials Acceleration Programme Matchpoint Trial." Blood 134, Supplement_1 (2019): 497. http://dx.doi.org/10.1182/blood-2019-125591.

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Background: The outcome of patients with blast phase chronic myeloid leukaemia (CML) remains extremely poor despite the advent of tyrosine kinase inhibitors (TKIs), and the majority of blast phase patients have already failed the currently licensed TKIs during the chronic phase. Currently there is no standard therapy for patients with blast phase CML, but most will receive 2 or 3 courses of chemotherapy or a TKI, followed by stem cell transplantation (alloSCT). In the PACE clinical trial of ponatinib, 23% of patients with blast phase CML achieved major cytogenetic response, with overall surviv

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Christian, Sonia, Kelley E. Kozma, Stephanie Barath, et al. "A Safety Study of the Addition of Omacetaxine to the Standard-of-Care Induction Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients." Blood 132, Supplement 1 (2018): 5218. http://dx.doi.org/10.1182/blood-2018-99-111412.

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Abstract Background: Omacetaxine mepesuccinate (OM) is a semi-synthetic form of Homoharringtonine (HH), a cephalotaxine alkaloid. OM induces cell apoptosis by inhibiting peptide bond formation during mRNA translation, with rapid loss of short-lived proteins, such as MCL-1, c-MYC, and Cyclin D1 (Lu, J Hematol Oncol. 2014, 7: 2). Notably, cytarabine synergizes with HH in causing apoptosis of leukemia cells in vitro. A phase III RCT in China of 620 patients with de novo AML demonstrated superior CR and 3-yr survival rates upon addition of HH to a standard 2-drug AML induction therapy ('7 + 3'; Ji

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Jabbour, Elias, Koji Sasaki, Naval Daver, et al. "Initial Results of a Randomized Phase II Study of Low Dose Decitabine (DAC) Versus Low Dose Azacitidine (AZA) in Patients with Low- or Intermediate-1-Risk Myelodysplastic Syndromes (MDS)." Blood 124, no. 21 (2014): 4640. http://dx.doi.org/10.1182/blood.v124.21.4640.4640.

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Abstract Background: The prognosis of patients with lower-risk MDS is heterogeneous; many have poor survival (Leukemia. 2008;22:538-543). Hypomethylating agents (HMA) improve the outcomes of patients with higher-risk MDS. Recent Phase I/II studies suggested that HMA doses below current standards of care retain activity in MDS, potentially with a better toxicity profile (JCO. 2009;27:1850-1856). We hypothesized that lower doses of HMA may be active and well tolerated in patients with lower-risk MDS. Aim: This is a phase II randomized trial to evaluate the efficacy and tolerability of low-dose r

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Cole, M., C. Yap, C. Buckley, et al. "TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis." Trials 22, no. 1 (2021). http://dx.doi.org/10.1186/s13063-021-05384-5.

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Abstract Background Adaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical complexity but uptake has been slow especially outside of cancer trials. TRAFIC is a multi-centre, early phase trial in rheumatoid arthritis incorporating a model-based design. Methods A Bayesian adaptive dose-finding phase I trial rolling into a single-arm, single-stage phase II trial. Model parameters for phase I were chosen via Monte Carlo simulation evaluating objective performance measures under clinically relevant scenarios and inco

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Yada, Shinjo. "Bayesian adaptive design of early-phase clinical trials for precision medicine based on cancer biomarkers." International Journal of Biostatistics, June 10, 2021. http://dx.doi.org/10.1515/ijb-2021-0009.

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Abstract Cancer tissue samples obtained via biopsy or surgery were examined for specific gene mutations by genetic testing to inform treatment. Precision medicine, which considers not only the cancer type and location, but also the genetic information, environment, and lifestyle of each patient, can be applied for disease prevention and treatment in individual patients. The number of patient-specific characteristics, including biomarkers, has been increasing with time; these characteristics are highly correlated with outcomes. The number of patients at the beginning of early-phase clinical tri

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Dissertations / Theses on the topic "Bayesian statistics, meta-analysis, phase I dose-escalation trials"

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Günhan, Burak Kürsad. "Bayesian methods for borrowing information in clinical drug development." Doctoral thesis, 2020. http://hdl.handle.net/21.11130/00-1735-0000-0005-151F-2.

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