Phase I–II trial design for biologic agents using conditional auto‐regressive models for toxicity and efficacy

Daniel G. Muenz; Jeremy M. G. Taylor; Thomas M. Braun

doi:10.1111/rssc.12314

Phase I–II trial design for biologic agents using conditional auto‐regressive models for toxicity and efficacy

Journal of the Royal Statistical Society Series C (Applied Statistics) ◽

10.1111/rssc.12314 ◽

2018 ◽

Vol 68 (2) ◽

pp. 331-345 ◽

Cited By ~ 2

Author(s):

Daniel G. Muenz ◽

Jeremy M. G. Taylor ◽

Thomas M. Braun

Keyword(s):

Phase I ◽

Trial Design ◽

Biologic Agents ◽

Auto Regressive

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Phase I/II clinical trial design for a novel therapy for mucopolysaccharidosis type I with an intravenously administered blood-brain barrier-crossing enzyme (JR-171)

Molecular Genetics and Metabolism ◽

10.1016/j.ymgme.2020.12.105 ◽

2021 ◽

Vol 132 (2) ◽

pp. S49

Author(s):

Ryo Higurashi ◽

Mika Okazaki ◽

Satoshi Kawashima ◽

Toshiaki Ikeda ◽

Sairei So ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Blood Brain Barrier ◽

Trial Design ◽

Clinical Trial Design ◽

Brain Barrier ◽

Type I ◽

Mucopolysaccharidosis Type ◽

Mucopolysaccharidosis Type I ◽

Novel Therapy

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Incorporating Historical Data in Bayesian Phase I Trial Design: The Caucasian-to-Asian Toxicity Tolerability Problem

Therapeutic Innovation & Regulatory Science ◽

10.1177/2168479014546333 ◽

2015 ◽

Vol 49 (1) ◽

pp. 93-99 ◽

Cited By ~ 4

Author(s):

Kentaro Takeda ◽

Satoshi Morita

Keyword(s):

Phase I ◽

Trial Design ◽

Phase I Trial ◽

Historical Data

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Is the “3+3” Dose-Escalation Phase I Clinical Trial Design Suitable for Therapeutic Cancer Vaccine Development? A Recommendation for Alternative Design

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-13-2671 ◽

2014 ◽

Vol 20 (18) ◽

pp. 4758-4767 ◽

Cited By ~ 25

Author(s):

Osama E. Rahma ◽

Emily Gammoh ◽

Richard M. Simon ◽

Samir N. Khleif

Keyword(s):

Clinical Trial ◽

Phase I ◽

Cancer Vaccine ◽

Dose Escalation ◽

Trial Design ◽

Vaccine Development ◽

Clinical Trial Design ◽

Phase I Clinical Trial ◽

Therapeutic Cancer Vaccine ◽

Alternative Design

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A Bayesian seamless phase I–II trial design with two stages for cancer clinical trials with drug combinations

Biometrical Journal ◽

10.1002/bimj.201900095 ◽

2020 ◽

Vol 62 (5) ◽

pp. 1300-1314 ◽

Cited By ~ 1

Author(s):

José L. Jiménez ◽

Sungjin Kim ◽

Mourad Tighiouart

Keyword(s):

Clinical Trials ◽

Phase I ◽

Trial Design ◽

Drug Combinations ◽

Cancer Clinical Trials ◽

Two Stages

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Early 3+3 Trial Dose-Escalation Phase I Clinical Trial Design and Suitability for Immune Checkpoint Inhibitors

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-20-2669 ◽

2020 ◽

Author(s):

Osama E. Rahma ◽

Joshua E. Reuss ◽

Anita Giobbie-Hurder ◽

Ghazaleh Shoja E Razavi ◽

Osama Abu-Shawer ◽

...

Keyword(s):

Clinical Trial ◽

Phase I ◽

Dose Escalation ◽

Immune Checkpoint ◽

Trial Design ◽

Immune Checkpoint Inhibitors ◽

Checkpoint Inhibitors ◽

Clinical Trial Design ◽

Phase I Clinical Trial

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A Bayesian adaptive phase I-II trial design for optimizing the schedule of therapeutic cancer vaccines

Statistics in Medicine ◽

10.1002/sim.7087 ◽

2016 ◽

Vol 36 (1) ◽

pp. 43-53 ◽

Cited By ~ 15

Author(s):

Kristen M. Cunanan ◽

Joseph S. Koopmeiners

Keyword(s):

Phase I ◽

Cancer Vaccines ◽

Trial Design ◽

Therapeutic Cancer Vaccines

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Adaptive Phase I clinical trial design using Markov models for conditional probability of toxicity

Journal of Biopharmaceutical Statistics ◽

10.1080/10543406.2015.1052492 ◽

2015 ◽

Vol 26 (3) ◽

pp. 475-498 ◽

Cited By ~ 4

Author(s):

Laura L. Fernandes ◽

Jeremy M. G. Taylor ◽

Susan Murray

Keyword(s):

Clinical Trial ◽

Phase I ◽

Conditional Probability ◽

Trial Design ◽

Markov Models ◽

Clinical Trial Design ◽

Phase I Clinical Trial

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Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design)

Success in Academic Surgery: Clinical Trials - Success in Academic Surgery ◽

10.1007/978-1-4471-4679-7_14 ◽

2013 ◽

pp. 169-177

Author(s):

Brigid K. Killelea ◽

Anees B. Chagpar

Keyword(s):

Phase I ◽

Factorial Design ◽

Trial Design ◽

Study Designs

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Bayesian dose-finding phase I trial design incorporating historical data from a preceding trial

Pharmaceutical Statistics ◽

10.1002/pst.1850 ◽

2018 ◽

Vol 17 (4) ◽

pp. 372-382 ◽

Cited By ~ 4

Author(s):

Kentaro Takeda ◽

Satoshi Morita

Keyword(s):

Phase I ◽

Trial Design ◽

Phase I Trial ◽

Historical Data ◽

Preceding Trial ◽

Dose Finding

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The Best Guess Approach to Phase I Trial Design

Journal of Clinical Oncology ◽

10.1200/jco.2006.02.4299 ◽

2006 ◽

Vol 24 (1) ◽

pp. 206-208 ◽

Cited By ~ 13

Author(s):

Daniela D. Rosa ◽

John Harris ◽

Gordon C. Jayson

Keyword(s):

Phase I ◽

Trial Design ◽

Phase I Trial

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