Literature DB >> 17981025

Recommended changes to oncology clinical trial design: revolution or evolution?

Mark J Ratain1, Rachel W Humphrey, Gary B Gordon, Gwen Fyfe, Peter C Adamson, Thomas R Fleming, Walter M Stadler, Donald A Berry, Carl C Peck.   

Abstract

Mesh：

Year:  2007        PMID： 17981025      PMCID： PMC2673461          DOI： 10.1016/j.ejca.2007.09.011

Source DB:  PubMed          Journal:  Eur J Cancer        ISSN： 0959-8049            Impact factor:   9.162


× No keyword cloud information.
  22 in total

Review 1.  Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.

Authors: 
Journal:  Clin Pharmacol Ther       Date:  2001-03       Impact factor: 6.875

2.  Non-randomised phase II trials of drug combinations: often meaningless, sometimes misleading. Are there alternative strategies?

Authors:  M Van Glabbeke; W Steward; J P Armand
Journal:  Eur J Cancer       Date:  2002-03       Impact factor: 9.162

Review 3.  Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval.

Authors:  Carl C Peck; Donald B Rubin; Lewis B Sheiner
Journal:  Clin Pharmacol Ther       Date:  2003-06       Impact factor: 6.875

Review 4.  Can the pharmaceutical industry reduce attrition rates?

Authors:  Ismail Kola; John Landis
Journal:  Nat Rev Drug Discov       Date:  2004-08       Impact factor: 84.694

Review 5.  Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approval.

Authors:  John Goffin; Stefan Baral; Dongsheng Tu; Dora Nomikos; Lesley Seymour
Journal:  Clin Cancer Res       Date:  2005-08-15       Impact factor: 12.531

6.  Phase II oncology trials: let's be positive.

Authors:  Mark J Ratain
Journal:  Clin Cancer Res       Date:  2005-08-15       Impact factor: 12.531

Review 7.  Learning versus confirming in clinical drug development.

Authors:  L B Sheiner
Journal:  Clin Pharmacol Ther       Date:  1997-03       Impact factor: 6.875

8.  Randomized phase II clinical trials.

Authors:  R Simon; R E Wittes; S S Ellenberg
Journal:  Cancer Treat Rep       Date:  1985-12

Review 9.  The ultimate model organism: progress in experimental medicine.

Authors:  Bruce H Littman; Stephen A Williams
Journal:  Nat Rev Drug Discov       Date:  2005-08       Impact factor: 84.694

10.  Some design issues in trials of microbicides for the prevention of HIV infection.

Authors:  Thomas R Fleming; Barbra A Richardson
Journal:  J Infect Dis       Date:  2004-07-20       Impact factor: 5.226
View more
  11 in total

Review 1.  Moving molecular targeted drug therapy towards personalized medicine: issues related to clinical trial design.

Authors:  Jaap Verweij; Maja de Jonge; Ferry Eskens; Stefan Sleijfer
Journal:  Mol Oncol       Date:  2012-02-16       Impact factor: 6.603

2.  Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection.

Authors:  Jian-Feng Lu; Erik Rasmussen; Beth Y Karlan; Ignace B Vergote; Lynn Navale; Mita Kuchimanchi; Rebeca Melara; Daniel E Stepan; David M Weinreich; Yu-Nien Sun
Journal:  Cancer Chemother Pharmacol       Date:  2012-01-01       Impact factor: 3.333

3.  An adaptive dose-finding design based on both safety and immunologic responses in cancer clinical trials.

Authors:  Cody Chiuzan; Elizabeth Garrett-Mayer; Michael Nishimura
Journal:  Stat Biopharm Res       Date:  2018-04-30       Impact factor: 1.452

4.  A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal® dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC).

Authors:  Michael R Harrison; Noah M Hahn; Roberto Pili; William K Oh; Hans Hammers; Christopher Sweeney; Kyungmann Kim; Scott Perlman; Jamie Arnott; Carolyn Sidor; George Wilding; Glenn Liu
Journal:  Invest New Drugs       Date:  2010-05-25       Impact factor: 3.850

Review 5.  Randomized phase II designs.

Authors:  Larry Rubinstein; John Crowley; Percy Ivy; Michael Leblanc; Dan Sargent
Journal:  Clin Cancer Res       Date:  2009-03-10       Impact factor: 12.531

6.  Comparison of power between randomized discontinuation design and upfront randomization design on progression-free survival.

Authors:  Pingfu Fu; Afshin Dowlati; Mark Schluchter
Journal:  J Clin Oncol       Date:  2009-07-27       Impact factor: 44.544

7.  Issues in using progression-free survival when evaluating oncology products.

Authors:  Thomas R Fleming; Mark D Rothmann; Hong Laura Lu
Journal:  J Clin Oncol       Date:  2009-05-04       Impact factor: 44.544

8.  Exposure-response analysis of rilotumumab in gastric cancer: the role of tumour MET expression.

Authors:  M Zhu; R Tang; S Doshi; K S Oliner; S Dubey; Y Jiang; R C Donehower; T Iveson; E Y Loh; Y Zhang
Journal:  Br J Cancer       Date:  2015-01-13       Impact factor: 7.640

9.  Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

Authors:  Julien Langrand-Escure; Romain Rivoirard; Mathieu Oriol; Fabien Tinquaut; Chloé Rancoule; Frank Chauvin; Nicolas Magné; Aurélie Bourmaud
Journal:  PLoS One       Date:  2017-12-07       Impact factor: 3.240

10.  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
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.