Literature DB >> 25949927

Advances in Statistical Approaches Oncology Drug Development.

Anastasia Ivanova1, Gary L Rosner2, Olga Marchenko3, Tom Parke4, Inna Perevozskaya5, Yanping Wang6.   

Abstract

We describe some recent developments in statistical methodology and practice in oncology drug development from an academic and an industry perspective. Many adaptive designs were pioneered in oncology, and oncology is still at the forefront of novel methods to enable better and faster Go/No-Go decision making while controlling the cost.

Entities:  

Keywords:  MTD; cancer trial; model-based design; oncology drug development; stopping rule

Year:  2014        PMID： 25949927      PMCID： PMC4418493          DOI： 10.1177/2168479013501309

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN： 2168-4790            Impact factor:   1.778


  59 in total

1.  A phase I dose-escalation study of clofarabine in combination with fractionated gemtuzumab ozogamicin in patients with refractory or relapsed acute myeloid leukemia.

Authors:  Matthew C Foster; Chirag Amin; Peter M Voorhees; Hendrik W van Deventer; Kristy L Richards; Anastasia Ivanova; Jennifer Whitman; Wingkeung Michael Chiu; Nathan D Barr; Thomas Shea
Journal:  Leuk Lymphoma       Date:  2012-01-31

2.  Bayesian two-stage designs for phase II clinical trials.

Authors:  Say-Beng Tan; David Machin
Journal:  Stat Med       Date:  2002-07-30       Impact factor: 2.373

3.  Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts.

Authors:  Frank Bretz; Heinz Schmidli; Franz König; Amy Racine; Willi Maurer
Journal:  Biom J       Date:  2006-08       Impact factor: 2.207

4.  Optimal two-stage randomized multinomial designs for Phase II oncology trials.

Authors:  Linda Z Sun; Cong Chen; Kamlesh Patel
Journal:  J Biopharm Stat       Date:  2009       Impact factor: 1.051

5.  Sequential continual reassessment method for two-dimensional dose finding.

Authors:  Ying Yuan; Guosheng Yin
Journal:  Stat Med       Date:  2008-11-29       Impact factor: 2.373

6.  A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information.

Authors:  Nigel Stallard
Journal:  Stat Med       Date:  2010-02-26       Impact factor: 2.373

7.  A hierarchical Bayesian design for phase I trials of novel combinations of cancer therapeutic agents.

Authors:  Thomas M Braun; Shufang Wang
Journal:  Biometrics       Date:  2010-09       Impact factor: 2.571

8.  One-sample multiple testing procedure for phase II clinical trials.

Authors:  T R Fleming
Journal:  Biometrics       Date:  1982-03       Impact factor: 2.571

9.  A phase I study of bortezomib in combination with standard 5-fluorouracil and external-beam radiation therapy for the treatment of locally advanced or metastatic rectal cancer.

Authors:  Bert H O'Neil; Laura Raftery; Benjamin F Calvo; A Bapsi Chakravarthy; Anastasia Ivanova; Michael O Myers; Hong Jin Kim; Emily Chan; Paul E Wise; Laura S Caskey; Stephen A Bernard; Hanna K Sanoff; Richard M Goldberg; Joel E Tepper
Journal:  Clin Colorectal Cancer       Date:  2010-04       Impact factor: 4.481

10.  Monitoring late-onset toxicities in phase I trials using predicted risks.

Authors:  B Nebiyou Bekele; Yuan Ji; Yu Shen; Peter F Thall
Journal:  Biostatistics       Date:  2007-12-14       Impact factor: 5.899
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