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Literature DB >> 26368744

Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

Anastasia Ivanova¹, Barry Paul², Olga Marchenko³, Guochen Song³, Neerali Patel⁴, Stergios J Moschos².

Abstract

We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.

Entities: Chemical Disease Gene Species

Keywords: Fleming’s design; Phase II trials; Simon’s design; oncology; two-stage design

Mesh：

Substances：
Antineoplastic Agents

Year: 2016 PMID： 26368744 PMCID： PMC5995106 DOI： 10.1080/10543406.2015.1092030

Source DB: PubMed Journal: J Biopharm Stat ISSN： 1054-3406 Impact factor: 1.051

29 in total

1. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.

Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther
Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506

2. Application of the triangular test to phase II cancer clinical trials.

Authors: E Bellissant; J Benichou; C Chastang
Journal: Stat Med Date: 1990-08 Impact factor: 2.373

3. Weekly paclitaxel and gemcitabine in advanced transitional-cell carcinoma of the urothelium: a phase II Hoosier Oncology Group study.

Authors: Jinxing Li; Beth Juliar; Constantin Yiannoutsos; Rafat Ansari; Edward Fox; Michael J Fisch; Lawrence H Einhorn; Christopher J Sweeney
Journal: J Clin Oncol Date: 2005-02-20 Impact factor: 44.544

4. Optimal two-stage designs for phase II clinical trials.

Authors: R Simon
Journal: Control Clin Trials Date: 1989-03

5. Methodologic guidelines for reports of clinical trials.

Authors: R Simon; R E Wittes
Journal: Cancer Treat Rep Date: 1985-01

6. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee.

Authors: Lesley Seymour; S Percy Ivy; Daniel Sargent; David Spriggs; Laurence Baker; Larry Rubinstein; Mark J Ratain; Michael Le Blanc; David Stewart; John Crowley; Susan Groshen; Jeffrey S Humphrey; Pamela West; Donald Berry
Journal: Clin Cancer Res Date: 2010-03-09 Impact factor: 12.531

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

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

8. Bevacizumab and everolimus in the treatment of patients with metastatic melanoma: a phase 2 trial of the Sarah Cannon Oncology Research Consortium.

Authors: John D Hainsworth; Jeffrey R Infante; David R Spigel; James D Peyton; Dana S Thompson; Cassie M Lane; Bobby L Clark; Mark S Rubin; David F Trent; Howard A Burris
Journal: Cancer Date: 2010-09-01 Impact factor: 6.860

9. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy.

Authors: José Baselga; Karen A Gelmon; Shailendra Verma; Andrew Wardley; Pierfranco Conte; David Miles; Giulia Bianchi; Javier Cortes; Virginia A McNally; Graham A Ross; Pierre Fumoleau; Luca Gianni
Journal: J Clin Oncol Date: 2010-02-01 Impact factor: 44.544

10. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial.

Authors: Bertram Glass; Justin Hasenkamp; Gerald Wulf; Peter Dreger; Michael Pfreundschuh; Martin Gramatzki; Gerda Silling; Christian Wilhelm; Matthias Zeis; Anke Görlitz; Sebastian Pfeiffer; Reinhard Hilgers; Lorenz Truemper; Norbert Schmitz
Journal: Lancet Oncol Date: 2014-05-11 Impact factor: 41.316

6 in total

Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

1. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.

2. Application of the triangular test to phase II cancer clinical trials.

3. Weekly paclitaxel and gemcitabine in advanced transitional-cell carcinoma of the urothelium: a phase II Hoosier Oncology Group study.

4. Optimal two-stage designs for phase II clinical trials.

5. Methodologic guidelines for reports of clinical trials.

6. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee.

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

8. Bevacizumab and everolimus in the treatment of patients with metastatic melanoma: a phase 2 trial of the Sarah Cannon Oncology Research Consortium.

9. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy.

10. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial.

1. Comment.

2. Futility stopping in clinical trials, optimality and practical considerations.

3. Re-formulating Gehan's design as a flexible two-stage single-arm trial.

Review 4. A Review of Perspectives on the Use of Randomization in Phase II Oncology Trials.

5. A two-stage design for phase II trials with time-to-event endpoint using restricted follow-up.

6. Two-Stage Single-Arm Trials Are Rarely Analyzed Effectively or Reported Adequately.