{"id":"https://openalex.org/W2005451950","doi":"https://doi.org/10.3109/00365521.2012.640836","title":"Predictive biomarkers in colorectal cancer: usage, validation, and design in clinical trials","display_name":"Predictive biomarkers in colorectal cancer: usage, validation, and design in clinical trials","publication_year":2011,"publication_date":"2011-12-19","ids":{"openalex":"https://openalex.org/W2005451950","doi":"https://doi.org/10.3109/00365521.2012.640836","mag":"2005451950","pmid":"https://pubmed.ncbi.nlm.nih.gov/22181041"},"language":"en","primary_location":{"id":"doi:10.3109/00365521.2012.640836","doi":"https://doi.org/10.3109/00365521.2012.640836","is_oa":false,"landing_page_url":"https://doi.org/10.3109/00365521.2012.640836","pdf_url":null,"source":{"id":"https://openalex.org/S55592950","display_name":"Scandinavian Journal of Gastroenterology","issn_l":"0036-5521","issn":["0036-5521","1502-7708"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-1","ki-jl-1","medline","norway-1"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Scandinavian Journal of Gastroenterology","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5049291606","display_name":"Qian Shi","orcid":"https://orcid.org/0000-0002-4640-8832","observed_orcids":["https://orcid.org/0000-0002-4640-8832"]},"institutions":[{"id":"https://openalex.org/I1330342723","display_name":"Mayo Clinic","ror":"https://ror.org/02qp3tb03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1330342723"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Qian Shi","raw_affiliation_strings":["Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA","Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA","institution_ids":["https://openalex.org/I1330342723"]},{"raw_affiliation_string":"Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA,","institution_ids":["https://openalex.org/I1330342723"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5002528975","display_name":"Sumithra J. Mandrekar","orcid":"https://orcid.org/0000-0002-7658-1134","observed_orcids":["https://orcid.org/0000-0002-7658-1134"]},"institutions":[{"id":"https://openalex.org/I1330342723","display_name":"Mayo Clinic","ror":"https://ror.org/02qp3tb03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1330342723"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Sumithra J. Mandrekar","raw_affiliation_strings":["Department of Health Science Research, Mayo Clinic, Rochester, MN, USA","Dept. of Health Sci., Res. Mayo Clinic, Rochester, MN, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Health Science Research, Mayo Clinic, Rochester, MN, USA","institution_ids":["https://openalex.org/I1330342723"]},{"raw_affiliation_string":"Dept. of Health Sci., Res. Mayo Clinic, Rochester, MN, USA","institution_ids":["https://openalex.org/I1330342723"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5023299002","display_name":"Daniel J. Sargent","orcid":"https://orcid.org/0000-0002-2684-4741","observed_orcids":["https://orcid.org/0000-0002-2684-4741"]},"institutions":[{"id":"https://openalex.org/I1330342723","display_name":"Mayo Clinic","ror":"https://ror.org/02qp3tb03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1330342723"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Daniel J. Sargent","raw_affiliation_strings":["Department of Health Science Research, Mayo Clinic, Rochester, MN, USA","Dept. of Health Sci., Res. Mayo Clinic, Rochester, MN, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Health Science Research, Mayo Clinic, Rochester, MN, USA","institution_ids":["https://openalex.org/I1330342723"]},{"raw_affiliation_string":"Dept. of Health Sci., Res. Mayo Clinic, Rochester, MN, USA","institution_ids":["https://openalex.org/I1330342723"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I1330342723"],"apc_list":null,"apc_paid":null,"fwci":1.9336,"has_fulltext":false,"cited_by_count":15,"citation_normalized_percentile":{"value":0.87095301,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"47","issue":"3","first_page":"356","last_page":"362"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.7714999914169312,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.7714999914169312,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11067","display_name":"Colorectal Cancer Treatments and Studies","score":0.20200000703334808,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10335","display_name":"Colorectal Cancer Surgical Treatments","score":0.002899999963119626,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/predictive-biomarkers","display_name":"predictive biomarkers","score":0.9990000128746033},{"id":"https://openalex.org/keywords/colorectal-cancer","display_name":"colorectal cancer","score":1.0},{"id":"https://openalex.org/keywords/biomarker-validation","display_name":"biomarker validation","score":0.9890000224113464},{"id":"https://openalex.org/keywords/clinical-trial-design","display_name":"clinical trial design","score":0.9769999980926514},{"id":"https://openalex.org/keywords/enrichment-design","display_name":"enrichment design","score":0.8420000076293945},{"id":"https://openalex.org/keywords/adaptive-design","display_name":"adaptive design","score":0.8320000171661377},{"id":"https://openalex.org/keywords/targeted-therapy","display_name":"targeted therapy","score":0.5799999833106995},{"id":"https://openalex.org/keywords/personalized-treatment-selection","display_name":"personalized treatment selection","score":0.45100000500679016}],"concepts":[{"id":"https://openalex.org/C526805850","wikidata":"https://www.wikidata.org/wiki/Q188874","display_name":"Colorectal cancer","level":3,"score":0.7545951008796692},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6063989996910095},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.5237481594085693},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5129596590995789},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.482133150100708},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.3707783818244934}],"mesh":[{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003657","descriptor_name":"Decision Making","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003657","descriptor_name":"Decision Making","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003657","descriptor_name":"Decision Making","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011237","descriptor_name":"Predictive Value of Tests","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011237","descriptor_name":"Predictive Value of Tests","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011237","descriptor_name":"Predictive Value of Tests","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D014408","descriptor_name":"Biomarkers, Tumor","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":false},{"descriptor_ui":"D014408","descriptor_name":"Biomarkers, Tumor","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":false},{"descriptor_ui":"D014408","descriptor_name":"Biomarkers, Tumor","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000378","qualifier_name":"metabolism","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000473","qualifier_name":"pathology","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000473","qualifier_name":"pathology","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000473","qualifier_name":"pathology","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000628","qualifier_name":"therapy","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000628","qualifier_name":"therapy","is_major_topic":false},{"descriptor_ui":"D015179","descriptor_name":"Colorectal Neoplasms","qualifier_ui":"Q000628","qualifier_name":"therapy","is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.3109/00365521.2012.640836","doi":"https://doi.org/10.3109/00365521.2012.640836","is_oa":false,"landing_page_url":"https://doi.org/10.3109/00365521.2012.640836","pdf_url":null,"source":{"id":"https://openalex.org/S55592950","display_name":"Scandinavian Journal of Gastroenterology","issn_l":"0036-5521","issn":["0036-5521","1502-7708"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-1","ki-jl-1","medline","norway-1"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Scandinavian Journal of Gastroenterology","raw_type":"journal-article"},{"id":"pmid:22181041","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/22181041","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Scandinavian journal of gastroenterology","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.9476000070571899,"display_name":"Good health and well-being"}],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/3","score":0.7300000190734863,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":48,"referenced_works":["https://openalex.org/W91108901","https://openalex.org/W1529479217","https://openalex.org/W1579641819","https://openalex.org/W1591730343","https://openalex.org/W1874410314","https://openalex.org/W1917103373","https://openalex.org/W1966267239","https://openalex.org/W1980705711","https://openalex.org/W1985046983","https://openalex.org/W2004325123","https://openalex.org/W2010163406","https://openalex.org/W2013563746","https://openalex.org/W2024226643","https://openalex.org/W2043571618","https://openalex.org/W2045521109","https://openalex.org/W2048265454","https://openalex.org/W2062758513","https://openalex.org/W2072938384","https://openalex.org/W2086421866","https://openalex.org/W2095692554","https://openalex.org/W2098184866","https://openalex.org/W2104152002","https://openalex.org/W2104830962","https://openalex.org/W2105400786","https://openalex.org/W2106789440","https://openalex.org/W2108710215","https://openalex.org/W2113499049","https://openalex.org/W2114850871","https://openalex.org/W2118782378","https://openalex.org/W2119974083","https://openalex.org/W2123543995","https://openalex.org/W2125071097","https://openalex.org/W2134763966","https://openalex.org/W2141667093","https://openalex.org/W2143143350","https://openalex.org/W2143858250","https://openalex.org/W2146384083","https://openalex.org/W2147026486","https://openalex.org/W2149875674","https://openalex.org/W2155311724","https://openalex.org/W2158734599","https://openalex.org/W2161630562","https://openalex.org/W2233806202","https://openalex.org/W2269165429","https://openalex.org/W2274832923","https://openalex.org/W2418915930","https://openalex.org/W2482707255","https://openalex.org/W2589823065"],"related_works":["https://openalex.org/W1966504330","https://openalex.org/W1979139803","https://openalex.org/W2037631372","https://openalex.org/W2073527559","https://openalex.org/W2030889776","https://openalex.org/W2159000141","https://openalex.org/W2070567609","https://openalex.org/W1974041167","https://openalex.org/W2391409986","https://openalex.org/W1978297557"],"abstract_inverted_index":{"As":[0],"cancer":[1],"treatment":[2,23,74],"development":[3],"has":[4],"shifted":[5],"its":[6],"attention":[7],"to":[8,16,28],"targeted":[9],"therapies,":[10],"it":[11],"is":[12],"becoming":[13],"increasingly":[14,54],"important":[15],"provide":[17,148],"tools":[18],"for":[19,24,79,97,174,182],"selecting":[20],"the":[21,38,42,45,48,86,93,98,151,156,162,175,178],"right":[22],"an":[25],"individual":[26],"patient":[27],"achieve":[29],"optimal":[30],"clinical":[31,88,94,179],"benefit.":[32],"Biomarkers,":[33],"identified":[34],"and":[35,66,90,113,138,147,153,169],"studied":[36],"in":[37,60],"process":[39],"of":[40,44,100,150,164,177,184],"understanding":[41],"nature":[43],"disease":[46],"at":[47],"molecular":[49],"pathogenesis":[50],"level,":[51],"have":[52],"been":[53],"recognized":[55],"as":[56],"a":[57],"critical":[58],"aspect":[59],"more":[61,91],"accurate":[62],"diagnosis,":[63],"prognosis":[64],"assessment,":[65],"therapeutic":[67],"targeting.":[68],"Predictive":[69,103],"biomarkers,":[70],"which":[71],"can":[72,107],"aid":[73],"decisions,":[75],"require":[76],"extensive":[77],"data":[78,119],"validation.":[80],"In":[81],"this":[82],"article,":[83],"we":[84],"discuss":[85,142],"definition,":[87],"usages,":[89],"extensively":[92],"trial":[95,180],"designs":[96,128],"validation":[99,105,117,183],"predictive":[101,187],"biomarkers.":[102],"biomarker":[104],"methods":[106],"be":[108],"broadly":[109],"grouped":[110],"into":[111],"retrospective":[112],"prospective":[114,123],"designs.":[115,140,158],"Retrospective":[116],"utilizes":[118],"from":[120],"previously":[121],"conducted":[122],"randomized":[124],"controlled":[125],"trials.":[126],"Prospective":[127],"include":[129],"enrichment":[130],"designs,":[131,134,137],"treatment-by-marker":[132],"interaction":[133],"marker-based":[135],"strategy":[136],"adaptive":[139],"We":[141,159],"each":[143,185],"design":[144,181],"with":[145],"examples":[146],"comparisons":[149],"advantages":[152],"disadvantages":[154],"among":[155],"different":[157],"conclude":[160],"that":[161],"combination":[163],"scientific,":[165],"clinical,":[166],"statistical,":[167],"ethical,":[168],"practical":[170],"considerations":[171],"provides":[172],"guidance":[173],"choice":[176],"proposed":[186],"biomarker.":[188]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2020,"cited_by_count":1},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":2},{"year":2014,"cited_by_count":2},{"year":2013,"cited_by_count":2},{"year":2012,"cited_by_count":2}],"updated_date":"2026-09-29T14:09:16.559479","created_date":"2025-10-10T00:00:00"}