Publication Information

{'id': 'https://openalex.org/W2411964580', 'doi': 'https://doi.org/10.1158/1078-0432.ccr-15-2644', 'title': 'Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy', 'display_name': 'Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy', 'publication_year': 2016, 'publication_date': '2016-05-31', 'ids': {'openalex': 'https://openalex.org/W2411964580', 'doi': 'https://doi.org/10.1158/1078-0432.ccr-15-2644', 'mag': '2411964580', 'pmid': 'https://pubmed.ncbi.nlm.nih.gov/27250933'}, 'language': 'en', 'primary_location': {'is_oa': False, 'landing_page_url': 'https://doi.org/10.1158/1078-0432.ccr-15-2644', 'pdf_url': None, 'source': {'id': 'https://openalex.org/S183149254', 'display_name': 'Clinical Cancer Research', 'issn_l': '1078-0432', 'issn': ['1078-0432', '1557-3265'], 'is_oa': False, 'is_in_doaj': False, 'is_core': True, 'host_organization': 'https://openalex.org/P4310320273', 'host_organization_name': 'American Association for Cancer Research', 'host_organization_lineage': ['https://openalex.org/P4310320273'], 'host_organization_lineage_names': ['American Association for Cancer Research'], 'type': 'journal'}, 'license': None, 'license_id': None, 'version': None, 'is_accepted': False, 'is_published': False}, 'type': 'editorial', 'type_crossref': 'journal-article', 'indexed_in': ['crossref', 'pubmed'], 'open_access': {'is_oa': False, 'oa_status': 'closed', 'oa_url': None, 'any_repository_has_fulltext': False}, 'authorships': [{'author_position': 'first', 'author': {'id': 'https://openalex.org/A5100642162', 'display_name': 'Lei Nie', 'orcid': 'https://orcid.org/0000-0002-7791-9395'}, 'institutions': [], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Lei Nie', 'raw_affiliation_strings': ['1Division of Biometrics V, OB/OTS/CDER/FDA, Silver Spring, Maryland.'], 'affiliations': [{'raw_affiliation_string': '1Division of Biometrics V, OB/OTS/CDER/FDA, Silver Spring, Maryland.', 'institution_ids': []}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5074861706', 'display_name': 'Eric H. Rubin', 'orcid': 'https://orcid.org/0000-0002-8032-7913'}, 'institutions': [], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Eric H. Rubin', 'raw_affiliation_strings': ['2Merck Research Laboratories, North Wales, Pennsylvania.'], 'affiliations': [{'raw_affiliation_string': '2Merck Research Laboratories, North Wales, Pennsylvania.', 'institution_ids': []}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5028489187', 'display_name': 'Nitin Mehrotra', 'orcid': 'https://orcid.org/0000-0002-9415-2720'}, 'institutions': [], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Nitin Mehrotra', 'raw_affiliation_strings': ['3Division of Pharmacometrics, OCP/OTS/CDER/FDA, Silver Spring, Maryland.'], 'affiliations': [{'raw_affiliation_string': '3Division of Pharmacometrics, OCP/OTS/CDER/FDA, Silver Spring, Maryland.', 'institution_ids': []}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5101957284', 'display_name': 'José Cirı́aco Pinheiro', 'orcid': 'https://orcid.org/0000-0001-8376-3086'}, 'institutions': [{'id': 'https://openalex.org/I1330063522', 'display_name': 'Johnson & Johnson (United States)', 'ror': 'https://ror.org/03qd7mz70', 'country_code': 'US', 'type': 'company', 'lineage': ['https://openalex.org/I1330063522']}], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'José Pinheiro', 'raw_affiliation_strings': ['4Johnson and Johnson, Raritan, New Jersey.'], 'affiliations': [{'raw_affiliation_string': '4Johnson and Johnson, Raritan, New Jersey.', 'institution_ids': ['https://openalex.org/I1330063522']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5083318636', 'display_name': 'Laura L. Fernandes', 'orcid': 'https://orcid.org/0000-0002-5986-3885'}, 'institutions': [], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Laura L. Fernandes', 'raw_affiliation_strings': ['1Division of Biometrics V, OB/OTS/CDER/FDA, Silver Spring, Maryland.'], 'affiliations': [{'raw_affiliation_string': '1Division of Biometrics V, OB/OTS/CDER/FDA, Silver Spring, Maryland.', 'institution_ids': []}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5103164539', 'display_name': 'Amit Roy', 'orcid': 'https://orcid.org/0000-0003-2140-1455'}, 'institutions': [{'id': 'https://openalex.org/I4210091812', 'display_name': 'Bristol-Myers Squibb (United States)', 'ror': 'https://ror.org/00gtmwv55', 'country_code': 'US', 'type': 'company', 'lineage': ['https://openalex.org/I4210091812']}], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Amit Roy', 'raw_affiliation_strings': ['5Bristol-Myers Squibb, Princeton, New Jersey.'], 'affiliations': [{'raw_affiliation_string': '5Bristol-Myers Squibb, Princeton, New Jersey.', 'institution_ids': ['https://openalex.org/I4210091812']}]}, {'author_position': 'middle', 'author': {'id': 'https://openalex.org/A5036435751', 'display_name': 'Stuart Bailey', 'orcid': 'https://orcid.org/0000-0003-1675-2808'}, 'institutions': [], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Stuart Bailey', 'raw_affiliation_strings': ['6Novartis Institutes for Biomedical Research, Cambridge, Massachusetts.'], 'affiliations': [{'raw_affiliation_string': '6Novartis Institutes for Biomedical Research, Cambridge, Massachusetts.', 'institution_ids': []}]}, {'author_position': 'last', 'author': {'id': 'https://openalex.org/A5076595940', 'display_name': 'Dinesh P. de Alwis', 'orcid': None}, 'institutions': [{'id': 'https://openalex.org/I1285764155', 'display_name': 'Merck & Co., Inc., Rahway, NJ, USA (United States)', 'ror': 'https://ror.org/02891sr49', 'country_code': 'US', 'type': 'company', 'lineage': ['https://openalex.org/I1285764155']}], 'countries': ['US'], 'is_corresponding': False, 'raw_author_name': 'Dinesh P. de Alwis', 'raw_affiliation_strings': ['7Merck Research Laboratories, Rahway, New Jersey.'], 'affiliations': [{'raw_affiliation_string': '7Merck Research Laboratories, Rahway, New Jersey.', 'institution_ids': ['https://openalex.org/I1285764155']}]}], 'institution_assertions': [], 'countries_distinct_count': 1, 'institutions_distinct_count': 3, 'corresponding_author_ids': [], 'corresponding_institution_ids': [], 'apc_list': None, 'apc_paid': None, 'fwci': None, 'has_fulltext': True, 'fulltext_origin': 'ngrams', 'cited_by_count': 57, 'citation_normalized_percentile': {'value': 0.947368, 'is_in_top_1_percent': False, 'is_in_top_10_percent': True}, 'cited_by_percentile_year': {'min': 96, 'max': 97}, 'biblio': {'volume': '22', 'issue': '11', 'first_page': '2623', 'last_page': '2629'}, 'is_retracted': False, 'is_paratext': False, 'primary_topic': {'id': 'https://openalex.org/T11235', 'display_name': 'Statistical Methods in Clinical Trials', 'score': 0.9999, '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': 0.9999, '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/T11287', 'display_name': 'Cancer Genomics and Diagnostics', 'score': 0.9959, 'subfield': {'id': 'https://openalex.org/subfields/1306', 'display_name': 'Cancer Research'}, 'field': {'id': 'https://openalex.org/fields/13', 'display_name': 'Biochemistry, Genetics and Molecular Biology'}, 'domain': {'id': 'https://openalex.org/domains/1', 'display_name': 'Life Sciences'}}, {'id': 'https://openalex.org/T11067', 'display_name': 'Colorectal Cancer Treatments and Studies', 'score': 0.9892, '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/maximum-tolerated-dose', 'display_name': 'Maximum tolerated dose', 'score': 0.63071775}, {'id': 'https://openalex.org/keywords/adaptive-design', 'display_name': 'Adaptive design', 'score': 0.4760701}, {'id': 'https://openalex.org/keywords/pharmacodynamics', 'display_name': 'Pharmacodynamics', 'score': 0.47391614}], 'concepts': [{'id': 'https://openalex.org/C71924100', 'wikidata': 'https://www.wikidata.org/wiki/Q11190', 'display_name': 'Medicine', 'level': 0, 'score': 0.7785163}, {'id': 'https://openalex.org/C535046627', 'wikidata': 'https://www.wikidata.org/wiki/Q30612', 'display_name': 'Clinical trial', 'level': 2, 'score': 0.67682576}, {'id': 'https://openalex.org/C2777334693', 'wikidata': 'https://www.wikidata.org/wiki/Q659446', 'display_name': 'Maximum tolerated dose', 'level': 3, 'score': 0.63071775}, {'id': 'https://openalex.org/C2777288759', 'wikidata': 'https://www.wikidata.org/wiki/Q4164182', 'display_name': 'Dosing', 'level': 2, 'score': 0.540813}, {'id': 'https://openalex.org/C2982777018', 'wikidata': 'https://www.wikidata.org/wiki/Q99268086', 'display_name': 'Adaptive design', 'level': 3, 'score': 0.4760701}, {'id': 'https://openalex.org/C111113717', 'wikidata': 'https://www.wikidata.org/wiki/Q725307', 'display_name': 'Pharmacodynamics', 'level': 3, 'score': 0.47391614}, {'id': 'https://openalex.org/C143998085', 'wikidata': 'https://www.wikidata.org/wiki/Q162555', 'display_name': 'Oncology', 'level': 1, 'score': 0.40572694}, {'id': 'https://openalex.org/C19527891', 'wikidata': 'https://www.wikidata.org/wiki/Q1120908', 'display_name': 'Medical physics', 'level': 1, 'score': 0.39066494}, {'id': 'https://openalex.org/C112705442', 'wikidata': 'https://www.wikidata.org/wiki/Q323936', 'display_name': 'Pharmacokinetics', 'level': 2, 'score': 0.36494553}, {'id': 'https://openalex.org/C98274493', 'wikidata': 'https://www.wikidata.org/wiki/Q128406', 'display_name': 'Pharmacology', 'level': 1, 'score': 0.3116396}, {'id': 'https://openalex.org/C126322002', 'wikidata': 'https://www.wikidata.org/wiki/Q11180', 'display_name': 'Internal medicine', 'level': 1, 'score': 0.24413311}], 'mesh': [{'descriptor_ui': 'D000970', 'descriptor_name': 'Antineoplastic Agents', 'qualifier_ui': 'Q000633', 'qualifier_name': 'toxicity', 'is_major_topic': True}, {'descriptor_ui': 'D009369', 'descriptor_name': 'Neoplasms', 'qualifier_ui': 'Q000188', 'qualifier_name': 'drug therapy', 'is_major_topic': True}, {'descriptor_ui': 'D000818', 'descriptor_name': 'Animals', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D000970', 'descriptor_name': 'Antineoplastic Agents', 'qualifier_ui': 'Q000627', 'qualifier_name': 'therapeutic use', 'is_major_topic': False}, {'descriptor_ui': 'D000970', 'descriptor_name': 'Antineoplastic Agents', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D002986', 'descriptor_name': 'Clinical Trials as Topic', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D006801', 'descriptor_name': 'Humans', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D020714', 'descriptor_name': 'Maximum Tolerated Dose', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D058990', 'descriptor_name': 'Molecular Targeted Therapy', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D009369', 'descriptor_name': 'Neoplasms', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}, {'descriptor_ui': 'D012107', 'descriptor_name': 'Research Design', 'qualifier_ui': '', 'qualifier_name': None, 'is_major_topic': False}], 'locations_count': 2, 'locations': [{'is_oa': False, 'landing_page_url': 'https://doi.org/10.1158/1078-0432.ccr-15-2644', 'pdf_url': None, 'source': {'id': 'https://openalex.org/S183149254', 'display_name': 'Clinical Cancer Research', 'issn_l': '1078-0432', 'issn': ['1078-0432', '1557-3265'], 'is_oa': False, 'is_in_doaj': False, 'is_core': True, 'host_organization': 'https://openalex.org/P4310320273', 'host_organization_name': 'American Association for Cancer Research', 'host_organization_lineage': ['https://openalex.org/P4310320273'], 'host_organization_lineage_names': ['American Association for Cancer Research'], 'type': 'journal'}, 'license': None, 'license_id': None, 'version': None, 'is_accepted': False, 'is_published': False}, {'is_oa': False, 'landing_page_url': 'https://pubmed.ncbi.nlm.nih.gov/27250933', 'pdf_url': None, 'source': {'id': 'https://openalex.org/S4306525036', 'display_name': 'PubMed', 'issn_l': None, 'issn': None, 'is_oa': False, 'is_in_doaj': False, 'is_core': False, 'host_organization': 'https://openalex.org/I1299303238', 'host_organization_name': 'National Institutes of Health', 'host_organization_lineage': ['https://openalex.org/I1299303238'], 'host_organization_lineage_names': ['National Institutes of Health'], 'type': 'repository'}, 'license': None, 'license_id': None, 'version': None, 'is_accepted': False, 'is_published': False}], 'best_oa_location': None, 'sustainable_development_goals': [{'display_name': 'Good health and well-being', 'score': 0.76, 'id': 'https://metadata.un.org/sdg/3'}], 'grants': [], 'datasets': [], 'versions': [], 'referenced_works_count': 29, 'referenced_works': ['https://openalex.org/W1061111608', 'https://openalex.org/W1963919702', 'https://openalex.org/W1973002971', 'https://openalex.org/W1982189141', 'https://openalex.org/W1994672023', 'https://openalex.org/W2024447346', 'https://openalex.org/W2027114592', 'https://openalex.org/W2045985885', 'https://openalex.org/W2054847594', 'https://openalex.org/W2076108528', 'https://openalex.org/W2078274740', 'https://openalex.org/W2083133947', 'https://openalex.org/W2093520916', 'https://openalex.org/W2100214216', 'https://openalex.org/W2104694028', 'https://openalex.org/W2107120363', 'https://openalex.org/W2109895173', 'https://openalex.org/W2113073012', 'https://openalex.org/W2118052473', 'https://openalex.org/W2124562077', 'https://openalex.org/W2136443647', 'https://openalex.org/W2158740848', 'https://openalex.org/W2160363302', 'https://openalex.org/W2167162853', 'https://openalex.org/W2415339357', 'https://openalex.org/W2415972817', 'https://openalex.org/W2418982839', 'https://openalex.org/W2468350542', 'https://openalex.org/W747827733'], 'related_works': ['https://openalex.org/W4246435665', 'https://openalex.org/W4243879999', 'https://openalex.org/W4232099051', 'https://openalex.org/W291055518', 'https://openalex.org/W2369345461', 'https://openalex.org/W2254638634', 'https://openalex.org/W2150271546', 'https://openalex.org/W2139311073', 'https://openalex.org/W2082798505', 'https://openalex.org/W1704005038'], 'abstract_inverted_index': {'Selection': [0], 'of': [1, 21, 32, 68, 151], 'the': [2, 8, 30, 69, 74, 139], 'maximum': [3], 'tolerated': [4], 'dose': [5, 10, 58, 97], '(MTD)': [6], 'as': [7, 104], 'recommended': [9, 47, 153], 'for': [11, 53, 96, 118], 'registration': [12, 161], 'trials': [13, 143], 'based': [14, 99], 'on': [15, 65, 100], 'a': [16, 88], 'dose-escalation': [17], 'trial': [18], 'using': [19], 'variations': [20], 'an': [22, 63, 77, 84], 'MTD/3': [23, 36, 70], '+': [24, 37, 71], '3': [25, 38, 72], 'design': [26], 'often': [27], 'occurs': [28], 'in': [29, 46, 57, 160], 'development': [31], 'oncology': [33], 'products.': [34], 'The': [35], 'approach': [39, 147], 'is': [40], 'not': [41], 'optimal': [42, 152], 'and': [43, 56, 93, 107, 115, 120, 137, 144], 'may': [44, 148], 'result': [45], 'doses': [48], 'that': [49, 60], 'are': [50], 'unacceptably': [51], 'toxic': [52], 'many': [54], 'patients': [55], 'reduction/interruptions': [59], 'might': [61], 'have': [62], 'impact': [64], 'effectiveness.': [66], 'Instead': [67], 'approach,': [73, 82], 'authors': [75], 'recommend': [76], 'integrated': [78], 'approach.': [79], 'In': [80], 'this': [81], 'typically': [83], 'adaptive/Bayesian': [85], 'model': [86], 'provides': [87], 'general': [89], 'framework': [90], 'to': [91, 135], 'incorporate': [92], 'make': [94], 'decisions': [95], 'escalation': [98], 'nonclinical': [101], 'data,': [102, 111], 'such': [103], 'animal': [105], 'efficacy': [106, 119], 'toxicity': [108], 'data;': [109, 114], 'clinical': [110], 'including': [112], 'pharmacokinetics/pharmacodynamics': [113], 'dose/exposure-response': [116], 'data': [117], 'safety.': [121], 'To': [122], 'improve': [123, 149], 'dose-ranging': [124], 'trials,': [125], 'model-based': [126], 'estimation,': [127], 'rather': [128], 'than': [129], 'hypothesis': [130], 'testing,': [131], 'should': [132], 'be': [133, 158], 'used': [134], 'maximize': [136], 'integrate': [138], 'information': [140], 'gathered': [141], 'across': [142], 'doses.': [145], 'This': [146], 'identification': [150], 'doses,': [154], 'which': [155], 'can': [156], 'then': [157], 'confirmed': [159], 'trials.': [162], 'Clin': [163], 'Cancer': [164], 'Res;': [165], '22(11);': [166], '2623-9.': [167], '©2016': [168], 'AACR': [169], 'SEE': [170], 'ALL': [171], 'ARTICLES': [172], 'IN': [173], 'THIS': [174], 'CCR': [175], 'FOCUS': [176], 'SECTION,': [177], '"NEW': [178], 'APPROACHES': [179], 'FOR': [180], 'OPTIMIZING': [181], 'DOSING': [182], 'OF': [183], 'ANTICANCER': [184], 'AGENTS".': [185]}, 'cited_by_api_url': 'https://api.openalex.org/works?filter=cites:W2411964580', 'counts_by_year': [{'year': 2024, 'cited_by_count': 5}, {'year': 2023, 'cited_by_count': 4}, {'year': 2022, 'cited_by_count': 7}, {'year': 2021, 'cited_by_count': 5}, {'year': 2020, 'cited_by_count': 5}, {'year': 2019, 'cited_by_count': 11}, {'year': 2018, 'cited_by_count': 7}, {'year': 2017, 'cited_by_count': 7}, {'year': 2016, 'cited_by_count': 5}], 'updated_date': '2024-12-09T05:58:58.892771', 'created_date': '2016-06-24'}