{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Kaplan R"],"funding":["Cancer Research UK","Medical Research Council","National Institute for Health Research (NIHR)"],"pagination":["4562-8"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4394353"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["31(36)"],"pubmed_abstract":["There is a pressing need for more-efficient trial designs for biomarker-stratified clinical trials. We suggest a new approach to trial design that links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II/III trial setting. We describe a new protocol using this approach in advanced colorectal cancer called FOCUS4. The protocol will ultimately answer three research questions for a number of treatments and biomarkers: (1) After a period of first-line chemotherapy, do targeted novel therapies provide signals of activity in different biomarker-defined populations? (2) If so, do these definitively improve outcomes? (3) Is evidence of activity restricted to the biomarker-defined groups? The protocol randomizes novel agents against placebo concu"],"journal":["Journal of clinical oncology : official journal of the American Society of Clinical Oncology"],"pubmed_title":["Evaluating many treatments and biomarkers in oncology: a new design."],"pmcid":["PMC4394353"],"funding_grant_id":["MC_EX_G0800814","13363","G0701770","11/100/50","EME/11/100/50","MC_U122861325","UD99999939","MC_UU_12023/25","MC_UU_12023/3"],"pubmed_authors":["Kaplan R","Wilson R","Brown L","Crook A","Maughan T","Parmar M","Fisher D"],"additional_accession":[]},"is_claimable":false,"name":"Evaluating many treatments and biomarkers in oncology: a new design.","description":"There is a pressing need for more-efficient trial designs for biomarker-stratified clinical trials. We suggest a new approach to trial design that links novel treatment evaluation with the concurrent evaluation of a biomarker within a confirmatory phase II/III trial setting. We describe a new protocol using this approach in advanced colorectal cancer called FOCUS4. The protocol will ultimately answer three research questions for a number of treatments and biomarkers: (1) After a period of first-line chemotherapy, do targeted novel therapies provide signals of activity in different biomarker-defined populations? (2) If so, do these definitively improve outcomes? (3) Is evidence of activity restricted to the biomarker-defined groups? The protocol randomizes novel agents against placebo concu","dates":{"release":"2013-01-01T00:00:00Z","publication":"2013 Dec","modification":"2025-04-04T00:28:59.659Z","creation":"2019-03-27T01:49:49Z"},"accession":"S-EPMC4394353","cross_references":{"pubmed":["24248692"],"doi":["10.1200/JCO.2013.50.7905","10.1200/jco.2013.50.7905"]}}