Changing the paradigm—multistage multiarm randomized trials and stratified cancer medicine

Oncologist

Volumn 20, Issue 8, 2015, Pages 849-851

  Lawler, Mark ^a   Kaplan, Rick ^b   Wilson, Richard H ^a   Maughan, Tim ^c  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER RESEARCH; CLINICAL TRIAL (TOPIC); COLORECTAL CANCER; DECISION MAKING; EDITORIAL; GENE MUTATION; HUMAN; PATIENT SELECTION; PRIORITY JOURNAL; CONTROLLED STUDY; NEOPLASM; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC);

HUMANS; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85018231159     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2015-0014     Document Type: Editorial

References (14)

1. Druker BJ, Talpaz M, Resta DJ et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001;344:1031–1037.
2. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2formetastatic breastcancer that overexpresses HER2. N Engl JMed 2001;344:783–792.
3. Doroshow JH, Sleijfer S, Stupp Retal. Cancer clinical trials—Do we need a new algorithm in the age of stratifiedmedicine? The Oncologist 2013;18:651–652.
4. Kehl KL, Arora NK, Schrag D et al. Discussions about clinical trials among patients with newly diagnosed lung and colorectal cancer. J Natl Cancer Inst 2014;106:106.
5. Sharma MR, Schilsky RL. Role of randomized phase III trials in an era of effective targeted therapies. Nat Rev Clin Oncol 2011;9:208–214.
6. Parmar MKB, Carpenter J, Sydes MR. More multiarm randomised trials of superiority are needed. Lancet 2014;384:283–284.
7. Kaplan R, Maughan T, Crook A et al. Evaluating many treatments and biomarkers in oncology: A new design. J Clin Oncol 2013;31:4562–4568.
8. Burki T. UK and US governments to fund personalised medicine. Lancet Oncol 2015;16: e108.
9. Parmar MKB, Barthel FM-S, Sydes M et al. Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst 2008;100:1204–1214.
10. Prahallad A, Sun C, Huang S et al. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature 2012; 483:100–103.
11. Lacombe D, Tejpar S, Salgado R et al. European perspective for effective cancer drug development. Nat Rev Clin Oncol 2014;11:492–498.
12. Schmoll H, Arnold D, De Gramont A et al. MODUL—A multicentre randomised clinical trial of biomarker-driven therapy for 1st-line maintenance treatment of metastatic colorectal cancer (MCRC):A signal-seeking approach. Ann Oncol 2014;25(suppl 4):4167–4209.
13. Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol 2014; 41:297–299.
14. Sydes MR, Parmar MK, Mason MD et al. Flexible trial design in practice—Stopping arms for lack-of-benefitandadding researcharmsmid-trial in STAMPEDE: A multi-arm multi-stage randomized controlled trial. Trials 2012;13:168.