Search Results - "Beckman, Robert A"

A roadmap to using historical controls in clinical trials - by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG) by Ghadessi, Mercedeh, Tang, Rui, Zhou, Joey, Liu, Rong, Wang, Chenkun, Toyoizumi, Kiichiro, Mei, Chaoqun, Zhang, Lixia, Deng, C Q, Beckman, Robert A

“…Historical controls (HCs) can be used for model parameter estimation at the study design phase, adaptation within a study, or supplementation or replacement of…”
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Neutral evolution of rare cancer mutations in the computer and the clinic by Beckman, Robert A.

“…A distinct model of neutral evolution of rare cancer mutations is described and contrasted with models relying on the infinite sites approximation (that a…”
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Design and Execution of Sustainable Decentralized Clinical Trials by Singh, Pritibha, Burden, Andrea M., Natanegara, Fanni, Beckman, Robert A.

“…The decentralized clinical trial (DCT) approach is increasingly recognized as a means to accelerate the development of potential therapeutic interventions…”
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Impact of genetic dynamics and single-cell heterogeneity on development of nonstandard personalized medicine strategies for cancer by Beckman, Robert A, Schemmann, Gunter S, Yeang, Chen-Hsiang

“…Cancers are heterogeneous and genetically unstable. Current practice of personalized medicine tailors therapy to heterogeneity between cancers of the same…”
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How Should Cancer Models Be Constructed? by Beckman, Robert A., Kareva, Irina, Adler, Frederick R.

“…Choosing and optimizing treatment strategies for cancer requires capturing its complex dynamics sufficiently well for understanding but without being…”
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Extensive subclonal mutational diversity in human colorectal cancer and its significance by Loeb, Lawrence A., Kohrn, Brendan F., Loubet-Senear, Kaitlyn J., Dunn, Yasmin J., Ahn, Eun Hyun, O’Sullivan, Jacintha N., Salk, Jesse J., Bronner, Mary P., Beckman, Robert A.

“…Human colorectal cancers (CRCs) contain both clonal and subclonal mutations. Clonal driver mutations are positively selected, present in most cells, and drive…”
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Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective by Ghadessi, Mercedeh, Di, Junrui, Wang, Chenkun, Toyoizumi, Kiichiro, Shao, Nan, Mei, Chaoqun, Demanuele, Charmaine, Tang, Rui Sammi, McMillan, Gianna, Beckman, Robert A

“…Traditional clinical trials require tests and procedures that are administered in centralized clinical research sites, which are beyond the standard of care…”
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Cancers exhibit a mutator phenotype: clinical implications by Loeb, Lawrence A, Bielas, Jason H, Beckman, Robert A

“…Malignancies are characterized by mutations. We have hypothesized that the thousands of mutations in most human cancers do not result from the low mutation…”
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Exploring approaches for predictive cancer patient digital twins: Opportunities for collaboration and innovation by Stahlberg, Eric A, Abdel-Rahman, Mohamed, Aguilar, Boris, Asadpoure, Alireza, Beckman, Robert A, Borkon, Lynn L, Bryan, Jeffrey N, Cebulla, Colleen M, Chang, Young Hwan, Chatterjee, Ansu, Deng, Jun, Dolatshahi, Sepideh, Gevaert, Olivier, Greenspan, Emily J, Hao, Wenrui, Hernandez-Boussard, Tina, Jackson, Pamela R, Kuijjer, Marieke, Lee, Adrian, Macklin, Paul, Madhavan, Subha, McCoy, Matthew D, Mohammad Mirzaei, Navid, Razzaghi, Talayeh, Rocha, Heber L, Shahriyari, Leili, Shmulevich, Ilya, Stover, Daniel G, Sun, Yi, Syeda-Mahmood, Tanveer, Wang, Jinhua, Wang, Qi, Zervantonakis, Ioannis

“…We are rapidly approaching a future in which cancer patient digital twins will reach their potential to predict cancer prevention, diagnosis, and treatment in…”
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Optimized adaptive enrichment designs by Ondra, Thomas, Jobjörnsson, Sebastian, Beckman, Robert A, Burman, Carl-Fredrik, König, Franz, Stallard, Nigel, Posch, Martin

“…Based on a Bayesian decision theoretic approach, we optimize frequentist single- and adaptive two-stage trial designs for the development of targeted…”
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A framework for assessing the impact of accelerated approval by Gould, A Lawrence, Campbell, Robert K, Loewy, John W, Beckman, Robert A, Dey, Jyotirmoy, Schiel, Anja, Burman, Carl-Fredrik, Zhou, Joey, Antonijevic, Zoran, Miller, Eva R, Tang, Rui

“…The FDA's Accelerated Approval program (AA) is a regulatory program to expedite availability of products to treat serious or life-threatening illnesses that…”
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Optimizing Trial Designs for Targeted Therapies by Ondra, Thomas, Jobjörnsson, Sebastian, Beckman, Robert A, Burman, Carl-Fredrik, König, Franz, Stallard, Nigel, Posch, Martin

“…An important objective in the development of targeted therapies is to identify the populations where the treatment under consideration has positive benefit…”
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Efficiency of Carcinogenesis with and without a Mutator Mutation by Beckman, Robert A., Loeb, Lawrence A.

“…Carcinogenesis involves the acquisition of multiple genetic changes altering various cellular phenotypes. These changes occur within the fixed time period of a…”
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Mutator mutations enhance tumorigenic efficiency across fitness landscapes by Beckman, Robert A

“…Tumorigenesis requires multiple genetic changes. Mutator mutations are mutations that increase genomic instability, and according to the mutator hypothesis,…”
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Envisioning the future of precision oncology trials by Madhavan, Subha, Beckman, Robert A, McCoy, Matthew D, Pishvaian, Michael J, Brody, Jonathan R, Macklin, Paul

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Phase I Evaluation of a Fully Human Anti–αv Integrin Monoclonal Antibody (CNTO 95) in Patients with Advanced Solid Tumors by MULLAMITHA, Saifee A, TON, Nhuan C, HOPE, Lynn, VALLE, Juan W, RADFORD, John A, LAWRANCE, Jeremy, SAUNDERS, Mark P, MUNTEANU, Mihaela C, NAKADA, Marian T, NEMETH, Jeffrey A, DAVIS, Hugh M, QUN JIAO, PARKER, Geoff J. M, PRABHAKAR, Uma, ZHIHUI LANG, CORRINGHAM, Robert E, BECKMAN, Robert A, JAYSON, Gordon C, JACKSON, Alan, JULYAN, Peter J, ROBERTS, Caleb, BUONACCORSI, Gio A, WATSON, Yvonne, DAVIES, Karen, CHEUNG, Sue

“…Purpose: A fully human monoclonal antibody to anti–α v integrins (CNTO 95) has been shown to inhibit angiogenesis and tumor growth in preclinical studies. We…”
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Pharmacogenetics and pharmacogenomics in oncology therapeutic antibody development by Yan, Li, Beckman, Robert A

“…Pharmacogenetics and pharmacogenomics are keys to the success of personalized medicine, prescribing drugs based on a patient's individual genetic and…”
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Clinical Translation and Validation of a Predictive Biomarker for Patritumab, an Anti-human Epidermal Growth Factor Receptor 3 (HER3) Monoclonal Antibody, in Patients With Advanced Non-small Cell Lung Cancer by Mendell, Jeanne, Freeman, Daniel J., Feng, Wenqin, Hettmann, Thore, Schneider, Matthias, Blum, Sabine, Ruhe, Jens, Bange, Johannes, Nakamaru, Kenji, Chen, Shuquan, Tsuchihashi, Zenta, von Pawel, Joachim, Copigneaux, Catherine, Beckman, Robert A.

“…During early clinical development, prospective identification of a predictive biomarker and validation of an assay method may not always be feasible…”
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Integrating predictive biomarkers and classifiers into oncology clinical development programmes by Beckman, Robert A, Clark, Jason, Chen, Cong

“…Predictive biomarkers allow the identification of the subsets of patients who will benefit from a particular drug. However, the development of biomarker–drug…”
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Optimal Cost-Effective Designs of Phase II Proof of Concept Trials and Associated Go-No Go Decisions by Chen, Cong, Beckman, Robert A.

“…This manuscript discusses optimal cost-effective designs for Phase II proof of concept (PoC) trials. Unlike a confirmatory registration trial, a PoC trial is…”
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