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Literature DB >> 25888066

The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research.

Abstract

Clinical trials are the final links in the chains of knowledge and for determining the roles of therapeutic advances. Unfortunately, in an important sense they are the weakest links. This article describes two designs that are being explored today: platform trials and basket trials. Both are attempting to merge clinical research and clinical practice.

Entities: Chemical Disease Gene Species

Keywords: Basket trials; Bayesian adaptive clinical trials; Biomarker-driven clinical trials; Platform trials

Mesh：

Substances：
Biomarkers, Tumor

Year: 2015 PMID： 25888066 PMCID： PMC4516171 DOI： 10.1016/j.molonc.2015.02.011

Source DB: PubMed Journal: Mol Oncol ISSN： 1574-7891 Impact factor: 6.603

18 in total

1. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy.

Authors: A D Barker; C C Sigman; G J Kelloff; N M Hylton; D A Berry; L J Esserman
Journal: Clin Pharmacol Ther Date: 2009-05-13 Impact factor: 6.875

2. The BATTLE trial: a bold step toward improving the efficiency of biomarker-based drug development.

Authors: Eric H Rubin; Keaven M Anderson; Christine K Gause
Journal: Cancer Discov Date: 2011-06-01 Impact factor: 39.397

Review 3. National Cancer Institute's Precision Medicine Initiatives for the new National Clinical Trials Network.

Authors: Jeffrey Abrams; Barbara Conley; Margaret Mooney; James Zwiebel; Alice Chen; John J Welch; Naoko Takebe; Shakun Malik; Lisa McShane; Edward Korn; Mickey Williams; Louis Staudt; James Doroshow
Journal: Am Soc Clin Oncol Educ Book Date: 2014

4. Detecting an overall survival benefit that is derived from progression-free survival.

Authors: Kristine R Broglio; Donald A Berry
Journal: J Natl Cancer Inst Date: 2009-11-09 Impact factor: 13.506

5. Neratinib Graduates to I-SPY 3.

Authors:
Journal: Cancer Discov Date: 2014-04-07 Impact factor: 39.397

6. Trial watch: Lung cancer trial aims to bolster personalized medicine.

Authors: Charlotte Harrison
Journal: Nat Rev Drug Discov Date: 2014-06 Impact factor: 84.694

7. Large personalised medicine trial in lung cancer heralds new research partnership.

Authors: Ingrid Torjesen
Journal: BMJ Date: 2014-04-16

8. Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials.

Authors: Donald A Berry; Roy S Herbst; Eric H Rubin
Journal: Clin Cancer Res Date: 2012-02-01 Impact factor: 12.531

9. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative.

Authors: Apostolia-Maria Tsimberidou; Nancy G Iskander; David S Hong; Jennifer J Wheler; Gerald S Falchook; Siqing Fu; Sarina Piha-Paul; Aung Naing; Filip Janku; Rajyalakshmi Luthra; Yang Ye; Sijin Wen; Donald Berry; Razelle Kurzrock
Journal: Clin Cancer Res Date: 2012-09-10 Impact factor: 12.531

10. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.

Authors:
Journal: J Am Coll Dent Date: 2014

43 in total

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Authors: Victor A Levin; Peter J Tonge; James M Gallo; Marc R Birtwistle; Arvin C Dar; Antonio Iavarone; Patrick J Paddison; Timothy P Heffron; William F Elmquist; Jean E Lachowicz; Ted W Johnson; Forest M White; Joohee Sul; Quentin R Smith; Wang Shen; Jann N Sarkaria; Ramakrishna Samala; Patrick Y Wen; Donald A Berry; Russell C Petter
Journal: Neuro Oncol Date: 2015-11 Impact factor: 12.300

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. Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer.

Authors: Hope S Rugo; Olufunmilayo I Olopade; Angela DeMichele; Christina Yau; Laura J van 't Veer; Meredith B Buxton; Michael Hogarth; Nola M Hylton; Melissa Paoloni; Jane Perlmutter; W Fraser Symmans; Douglas Yee; A Jo Chien; Anne M Wallace; Henry G Kaplan; Judy C Boughey; Tufia C Haddad; Kathy S Albain; Minetta C Liu; Claudine Isaacs; Qamar J Khan; Julie E Lang; Rebecca K Viscusi; Lajos Pusztai; Stacy L Moulder; Stephen Y Chui; Kathleen A Kemmer; Anthony D Elias; Kirsten K Edmiston; David M Euhus; Barbara B Haley; Rita Nanda; Donald W Northfelt; Debasish Tripathy; William C Wood; Cheryl Ewing; Richard Schwab; Julia Lyandres; Sarah E Davis; Gillian L Hirst; Ashish Sanil; Donald A Berry; Laura J Esserman
Journal: N Engl J Med Date: 2016-07-07 Impact factor: 91.245

5. Adaptive Randomization of Neratinib in Early Breast Cancer.

Authors: John W Park; Minetta C Liu; Douglas Yee; Christina Yau; Laura J van 't Veer; W Fraser Symmans; Melissa Paoloni; Jane Perlmutter; Nola M Hylton; Michael Hogarth; Angela DeMichele; Meredith B Buxton; A Jo Chien; Anne M Wallace; Judy C Boughey; Tufia C Haddad; Stephen Y Chui; Kathleen A Kemmer; Henry G Kaplan; Claudine Isaacs; Rita Nanda; Debasish Tripathy; Kathy S Albain; Kirsten K Edmiston; Anthony D Elias; Donald W Northfelt; Lajos Pusztai; Stacy L Moulder; Julie E Lang; Rebecca K Viscusi; David M Euhus; Barbara B Haley; Qamar J Khan; William C Wood; Michelle Melisko; Richard Schwab; Teresa Helsten; Julia Lyandres; Sarah E Davis; Gillian L Hirst; Ashish Sanil; Laura J Esserman; Donald A Berry
Journal: N Engl J Med Date: 2016-07-07 Impact factor: 91.245

6. Advancing Clinical Trials to Streamline Drug Development.

Authors: Susan E Bates; Donald A Berry; Sanjeeve Balasubramaniam; Stuart Bailey; Patricia M LoRusso; Eric H Rubin
Journal: Clin Cancer Res Date: 2015-10-15 Impact factor: 12.531

Review 7. Early-Phase Platform Trials: A New Paradigm for Dose Finding and Treatment Screening in the Era of Precision Oncology.

Authors: Mei-Yin C Polley; Ying Kuen Cheung
Journal: JCO Precis Oncol Date: 2019-10-24

8. Testing many treatments within a single protocol over 10 years at MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols.

Authors: Mahesh Kb Parmar; Matthew R Sydes; Fay H Cafferty; Babak Choodari-Oskooei; Ruth E Langley; Louise Brown; Patrick Pj Phillips; Melissa R Spears; Sam Rowley; Richard Kaplan; Nicholas D James; Timothy Maughan; Nicholas Paton; Patrick J Royston
Journal: Clin Trials Date: 2017-08-22 Impact factor: 2.486

Review 9. Precision oncology: A new era of cancer clinical trials.

Authors: Lindsay A Renfro; Ming-Wen An; Sumithra J Mandrekar
Journal: Cancer Lett Date: 2016-03-14 Impact factor: 8.679

10. MK-2206 and Standard Neoadjuvant Chemotherapy Improves Response in Patients With Human Epidermal Growth Factor Receptor 2-Positive and/or Hormone Receptor-Negative Breast Cancers in the I-SPY 2 Trial.

Authors: A Jo Chien; Debasish Tripathy; Kathy S Albain; W Fraser Symmans; Hope S Rugo; Michelle E Melisko; Anne M Wallace; Richard Schwab; Teresa Helsten; Andres Forero-Torres; Erica Stringer-Reasor; Erin D Ellis; Henry G Kaplan; Rita Nanda; Nora Jaskowiak; Rashmi Murthy; Constantine Godellas; Judy C Boughey; Anthony D Elias; Barbara B Haley; Kathleen Kemmer; Claudine Isaacs; Amy S Clark; Julie E Lang; Janice Lu; Larissa Korde; Kirsten K Edmiston; Donald W Northfelt; Rebecca K Viscusi; Douglas Yee; Jane Perlmutter; Nola M Hylton; Laura J Van't Veer; Angela DeMichele; Amy Wilson; Garry Peterson; Meredith B Buxton; Melissa Paoloni; Julia Clennell; Scott Berry; Jeffrey B Matthews; Katherine Steeg; Ruby Singhrao; Gillian L Hirst; Ashish Sanil; Christina Yau; Smita M Asare; Donald A Berry; Laura J Esserman
Journal: J Clin Oncol Date: 2019-02-07 Impact factor: 44.544