Literature DB >> 21709273

More randomization in phase II trials: necessary but not sufficient.

Lawrence Rubinstein, Michael Leblanc, Malcolm A Smith.   

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Year:  2011        PMID： 21709273      PMCID： PMC3139589          DOI： 10.1093/jnci/djr238

Source DB:  PubMed          Journal:  J Natl Cancer Inst        ISSN： 0027-8874            Impact factor:   13.506


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  39 in total

1.  Randomized phase II trials: inevitable or inadvisable?

Authors:  Hui K Gan; Axel Grothey; Gregory R Pond; Malcolm J Moore; Lillian L Siu; Daniel Sargent
Journal:  J Clin Oncol       Date:  2010-04-20       Impact factor: 44.544

2.  Comparison of error rates in single-arm versus randomized phase II cancer clinical trials.

Authors:  Hui Tang; Nathan R Foster; Axel Grothey; Stephen M Ansell; Richard M Goldberg; Daniel J Sargent
Journal:  J Clin Oncol       Date:  2010-03-08       Impact factor: 44.544

3.  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

Review 4.  The evolving field of tyrosine kinase inhibitors in the treatment of endocrine tumors.

Authors:  Lei Ye; Libero Santarpia; Robert F Gagel
Journal:  Endocr Rev       Date:  2010-07-06       Impact factor: 19.871

5.  Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303).

Authors:  Hedy Lee Kindler; Donna Niedzwiecki; Donna Hollis; Susan Sutherland; Deborah Schrag; Herbert Hurwitz; Federico Innocenti; Mary Frances Mulcahy; Eileen O'Reilly; Timothy F Wozniak; Joel Picus; Pankaj Bhargava; Robert J Mayer; Richard L Schilsky; Richard M Goldberg
Journal:  J Clin Oncol       Date:  2010-07-06       Impact factor: 44.544

6.  Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer.

Authors:  David W Miles; Arlene Chan; Luc Y Dirix; Javier Cortés; Xavier Pivot; Piotr Tomczak; Thierry Delozier; Joo Hyuk Sohn; Louise Provencher; Fabio Puglisi; Nadia Harbeck; Guenther G Steger; Andreas Schneeweiss; Andrew M Wardley; Andreas Chlistalla; Gilles Romieu
Journal:  J Clin Oncol       Date:  2010-05-24       Impact factor: 44.544

7.  Validation of novel imaging methodologies for use as cancer clinical trial end-points.

Authors:  D J Sargent; L Rubinstein; L Schwartz; J E Dancey; C Gatsonis; L E Dodd; L K Shankar
Journal:  Eur J Cancer       Date:  2008-12-16       Impact factor: 9.162

8.  FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma.

Authors:  Jeff Summers; Martin H Cohen; Patricia Keegan; Richard Pazdur
Journal:  Oncologist       Date:  2010-01-08

9.  Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a children's oncology group study.

Authors:  Kirk R Schultz; W Paul Bowman; Alexander Aledo; William B Slayton; Harland Sather; Meenakshi Devidas; Chenguang Wang; Stella M Davies; Paul S Gaynon; Michael Trigg; Robert Rutledge; Laura Burden; Dean Jorstad; Andrew Carroll; Nyla A Heerema; Naomi Winick; Michael J Borowitz; Stephen P Hunger; William L Carroll; Bruce Camitta
Journal:  J Clin Oncol       Date:  2009-10-05       Impact factor: 44.544

10.  Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial.

Authors:  Cora N Sternberg; Ian D Davis; Jozef Mardiak; Cezary Szczylik; Eunsik Lee; John Wagstaff; Carlos H Barrios; Pamela Salman; Oleg A Gladkov; Alexander Kavina; Juan J Zarbá; Mei Chen; Lauren McCann; Lini Pandite; Debasish F Roychowdhury; Robert E Hawkins
Journal:  J Clin Oncol       Date:  2010-01-25       Impact factor: 44.544
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  9 in total

1.  Choosing phase II endpoints and designs: evaluating the possibilities.

Authors:  Michael LeBlanc; Catherine Tangen
Journal:  Clin Cancer Res       Date:  2012-03-08       Impact factor: 12.531

2.  Design and Evaluation of an External Control Arm Using Prior Clinical Trials and Real-World Data.

Authors:  Steffen Ventz; Albert Lai; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Clin Cancer Res       Date:  2019-06-07       Impact factor: 12.531

3.  To randomize, or not to randomize, that is the question: using data from prior clinical trials to guide future designs.

Authors:  Alyssa M Vanderbeek; Steffen Ventz; Rifaquat Rahman; Geoffrey Fell; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Neuro Oncol       Date:  2019-10-09       Impact factor: 12.300

4.  Pancreatic cancer: why is it so hard to treat?

Authors:  Paul E Oberstein; Kenneth P Olive
Journal:  Therap Adv Gastroenterol       Date:  2013-07       Impact factor: 4.409

5.  Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.

Authors:  Ming-Wen An; Yu Han; Jeffrey P Meyers; Jan Bogaerts; Daniel J Sargent; Sumithra J Mandrekar
Journal:  J Clin Oncol       Date:  2015-10-26       Impact factor: 44.544

Review 6.  A Review of Perspectives on the Use of Randomization in Phase II Oncology Trials.

Authors:  Michael J Grayling; Munyaradzi Dimairo; Adrian P Mander; Thomas F Jaki
Journal:  J Natl Cancer Inst       Date:  2019-12-01       Impact factor: 13.506

7.  Inclusion of non-inferiority analysis in superiority-based clinical trials with single-arm, two-stage Simon's design.

Authors:  Miguel Sampayo-Cordero; Bernat Miguel-Huguet; José Pérez-García; David Páez; Ángel L Guerrero-Zotano; Javier Garde-Noguera; Elena Aguirre; Esther Holgado; Elena López-Miranda; Xin Huang; Andrea Malfettone; Antonio Llombart-Cussac; Javier Cortés
Journal:  Contemp Clin Trials Commun       Date:  2020-11-28

8.  Estimation of renal cell carcinoma treatment effects from disease progression modeling.

Authors:  M L Maitland; K Wu; M R Sharma; Y Jin; S P Kang; W M Stadler; T G Karrison; M J Ratain; R R Bies
Journal:  Clin Pharmacol Ther       Date:  2012-12-27       Impact factor: 6.875

9.  Do single-arm trials have a role in drug development plans incorporating randomised trials?

Authors:  Michael J Grayling; Adrian P Mander
Journal:  Pharm Stat       Date:  2015-11-26       Impact factor: 1.894
  9 in total

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