{"id":"https://openalex.org/W2896532728","doi":"https://doi.org/10.1186/s13063-018-2934-7","title":"Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan","display_name":"Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan","publication_year":2018,"publication_date":"2018-10-19","ids":{"openalex":"https://openalex.org/W2896532728","doi":"https://doi.org/10.1186/s13063-018-2934-7","mag":"2896532728","pmid":"https://pubmed.ncbi.nlm.nih.gov/30340624","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/6194696"},"language":"en","primary_location":{"id":"doi:10.1186/s13063-018-2934-7","doi":"https://doi.org/10.1186/s13063-018-2934-7","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s13063-018-2934-7","pdf_url":"https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-018-2934-7","source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},"parent_works":[],"lineage":["https://openalex.org/W2896532728"],"child_works_count":0,"type":"review","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-018-2934-7","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5047531932","display_name":"Lauren E. Kelly","orcid":"https://orcid.org/0000-0001-7567-0816","observed_orcids":["https://orcid.org/0000-0001-7567-0816"]},"institutions":[{"id":"https://openalex.org/I4210098764","display_name":"George & Fay Yee Centre for Healthcare Innovation","ror":"https://ror.org/0117s0n37","country_code":"CA","type":"facility","lineage":["https://openalex.org/I121800195","https://openalex.org/I4210098764","https://openalex.org/I46247651"]},{"id":"https://openalex.org/I46247651","display_name":"University of Manitoba","ror":"https://ror.org/02gfys938","country_code":"CA","type":"education","lineage":["https://openalex.org/I46247651"]}],"countries":["CA"],"is_corresponding":true,"raw_author_name":"Lauren E Kelly","raw_affiliation_strings":["Clinical Trials Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada. lauren.kelly@umanitoba.ca","Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada. lauren.kelly@umanitoba.ca","Department of Pediatrics and Child Health, The University of Manitoba, 405 Chown, 753 McDermot Ave., Winnipeg, MB, R3E0T6, Canada. lauren.kelly@umanitoba.ca","Department of Pediatrics and Child Health, The University of Manitoba, 405 Chown, 753 McDermot Ave., Winnipeg, MB, R3E0T6, Canada"],"raw_orcid":"https://orcid.org/0000-0001-7567-0816","affiliations":[{"raw_affiliation_string":"Clinical Trials Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada. lauren.kelly@umanitoba.ca","institution_ids":["https://openalex.org/I4210098764"]},{"raw_affiliation_string":"Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada. lauren.kelly@umanitoba.ca","institution_ids":["https://openalex.org/I46247651"]},{"raw_affiliation_string":"Department of Pediatrics and Child Health, The University of Manitoba, 405 Chown, 753 McDermot Ave., Winnipeg, MB, R3E0T6, Canada. lauren.kelly@umanitoba.ca","institution_ids":["https://openalex.org/I46247651"]},{"raw_affiliation_string":"Department of Pediatrics and Child Health, The University of Manitoba, 405 Chown, 753 McDermot Ave., Winnipeg, MB, R3E0T6, Canada","institution_ids":["https://openalex.org/I46247651"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5069929460","display_name":"Michele P. Dyson","orcid":"https://orcid.org/0000-0003-4856-2283","observed_orcids":["https://orcid.org/0000-0003-4856-2283"]},"institutions":[{"id":"https://openalex.org/I154425047","display_name":"University of Alberta","ror":"https://ror.org/0160cpw27","country_code":"CA","type":"education","lineage":["https://openalex.org/I154425047"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Michele P Dyson","raw_affiliation_strings":["Department of Pediatrics, University of Alberta, Edmonton, AB, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pediatrics, University of Alberta, Edmonton, AB, Canada","institution_ids":["https://openalex.org/I154425047"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074962363","display_name":"Nancy J. Butcher","orcid":"https://orcid.org/0000-0002-5152-0108","observed_orcids":["https://orcid.org/0000-0002-5152-0108"]},"institutions":[{"id":"https://openalex.org/I2801317318","display_name":"Hospital for Sick Children","ror":"https://ror.org/057q4rt57","country_code":"CA","type":"healthcare","lineage":["https://openalex.org/I2801317318"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Nancy J Butcher","raw_affiliation_strings":["Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada","institution_ids":["https://openalex.org/I2801317318"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5044718702","display_name":"Robert F Balshaw","orcid":"https://orcid.org/0000-0002-2455-8792","observed_orcids":["https://orcid.org/0000-0002-2455-8792"]},"institutions":[{"id":"https://openalex.org/I4210098764","display_name":"George & Fay Yee Centre for Healthcare Innovation","ror":"https://ror.org/0117s0n37","country_code":"CA","type":"facility","lineage":["https://openalex.org/I121800195","https://openalex.org/I4210098764","https://openalex.org/I46247651"]},{"id":"https://openalex.org/I46247651","display_name":"University of Manitoba","ror":"https://ror.org/02gfys938","country_code":"CA","type":"education","lineage":["https://openalex.org/I46247651"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Robert Balshaw","raw_affiliation_strings":["Data Science Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada","Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Data Science Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I4210098764"]},{"raw_affiliation_string":"Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I46247651"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5042431726","display_name":"Alex John London","orcid":"https://orcid.org/0000-0002-6450-0309","observed_orcids":["https://orcid.org/0000-0002-6450-0309"]},"institutions":[{"id":"https://openalex.org/I74973139","display_name":"Carnegie Mellon University","ror":"https://ror.org/05x2bcf33","country_code":"US","type":"education","lineage":["https://openalex.org/I74973139"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Alex John London","raw_affiliation_strings":["Center for Ethics and Policy, Carnegie Mellon University, Pittsburgh, PA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Center for Ethics and Policy, Carnegie Mellon University, Pittsburgh, PA, USA","institution_ids":["https://openalex.org/I74973139"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075661907","display_name":"Christine Joann Neilson","orcid":"https://orcid.org/0000-0002-0525-737X","observed_orcids":["https://orcid.org/0000-0002-0525-737X"]},"institutions":[{"id":"https://openalex.org/I46247651","display_name":"University of Manitoba","ror":"https://ror.org/02gfys938","country_code":"CA","type":"education","lineage":["https://openalex.org/I46247651"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Christine J Neilson","raw_affiliation_strings":["Neil John Maclean Health Sciences Library, University of Manitoba, Winnipeg, MB, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Neil John Maclean Health Sciences Library, University of Manitoba, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I46247651"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5067935354","display_name":"Anne Junker","orcid":"https://orcid.org/0000-0002-5286-7672","observed_orcids":["https://orcid.org/0000-0002-5286-7672"]},"institutions":[{"id":"https://openalex.org/I4210153200","display_name":"BC Children's Hospital","ror":"https://ror.org/04n901w50","country_code":"CA","type":"healthcare","lineage":["https://openalex.org/I4210153200"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Anne Junker","raw_affiliation_strings":["Department of Allergy and Immunology, British Columbia Children's Hospital, Vancouver, BC, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Allergy and Immunology, British Columbia Children's Hospital, Vancouver, BC, Canada","institution_ids":["https://openalex.org/I4210153200"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074655032","display_name":"Salaheddin M. Mahmud","orcid":"https://orcid.org/0000-0002-6574-0574","observed_orcids":["https://orcid.org/0000-0002-6574-0574"]},"institutions":[{"id":"https://openalex.org/I4210098764","display_name":"George & Fay Yee Centre for Healthcare Innovation","ror":"https://ror.org/0117s0n37","country_code":"CA","type":"facility","lineage":["https://openalex.org/I121800195","https://openalex.org/I4210098764","https://openalex.org/I46247651"]},{"id":"https://openalex.org/I46247651","display_name":"University of Manitoba","ror":"https://ror.org/02gfys938","country_code":"CA","type":"education","lineage":["https://openalex.org/I46247651"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Salaheddin M Mahmud","raw_affiliation_strings":["Clinical Trials Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada","Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada","Vaccine and Drug Evaluation Centre, University of Manitoba, Winnipeg, MB, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Trials Platform, George & Fay Yee Centre for Healthcare Innovation, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I4210098764"]},{"raw_affiliation_string":"Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I46247651"]},{"raw_affiliation_string":"Vaccine and Drug Evaluation Centre, University of Manitoba, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I46247651"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5007993534","display_name":"S. Michelle Driedger","orcid":"https://orcid.org/0000-0003-3769-5785","observed_orcids":["https://orcid.org/0000-0003-3769-5785"]},"institutions":[{"id":"https://openalex.org/I46247651","display_name":"University of Manitoba","ror":"https://ror.org/02gfys938","country_code":"CA","type":"education","lineage":["https://openalex.org/I46247651"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"S Michelle Driedger","raw_affiliation_strings":["Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Community Health Sciences, University of Manitoba, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I46247651"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5008086724","display_name":"Xikui Wang","orcid":"https://orcid.org/0000-0002-4157-396X","observed_orcids":["https://orcid.org/0000-0002-4157-396X"]},"institutions":[{"id":"https://openalex.org/I46247651","display_name":"University of Manitoba","ror":"https://ror.org/02gfys938","country_code":"CA","type":"education","lineage":["https://openalex.org/I46247651"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Xikui Wang","raw_affiliation_strings":["Department of Statistics, University of Manitoba, Winnipeg, MB, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Statistics, University of Manitoba, Winnipeg, MB, Canada","institution_ids":["https://openalex.org/I46247651"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":6,"corresponding_author_ids":["https://openalex.org/A5047531932"],"corresponding_institution_ids":["https://openalex.org/I4210098764","https://openalex.org/I46247651"],"apc_list":{"value":2790,"currency":"USD","value_usd":2790},"apc_paid":{"value":2790,"currency":"USD","value_usd":2790},"fwci":0.2162,"has_fulltext":true,"cited_by_count":18,"citation_normalized_percentile":{"value":0.34170854,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":98},"biblio":{"volume":"19","issue":"1","first_page":"572","last_page":"572"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.8726000189781189,"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":0.8726000189781189,"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/T12547","display_name":"Pharmaceutical studies and practices","score":0.12559999525547028,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"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/T10582","display_name":"Ethics in Clinical Research","score":0.000699999975040555,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"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/adaptive-trial-design","display_name":"adaptive trial design","score":0.7850000262260437},{"id":"https://openalex.org/keywords/pediatric-clinical-trials","display_name":"pediatric clinical trials","score":0.9990000128746033},{"id":"https://openalex.org/keywords/regulatory-aspects","display_name":"regulatory considerations","score":0.8130000233650208},{"id":"https://openalex.org/keywords/research-ethics","display_name":"research ethics","score":0.9070000052452087},{"id":"https://openalex.org/keywords/statistical-considerations","display_name":"statistical considerations","score":0.7630000114440918},{"id":"https://openalex.org/keywords/trial-efficiency","display_name":"trial efficiency","score":0.7689999938011169},{"id":"https://openalex.org/keywords/best-practices-recommendations","display_name":"best practices recommendations","score":0.6349999904632568},{"id":"https://openalex.org/keywords/stakeholder-engagement","display_name":"stakeholder engagement","score":0.7770000100135803},{"id":"https://openalex.org/keywords/knowledge-translation","display_name":"knowledge translation","score":0.7049999833106995}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6843068599700928},{"id":"https://openalex.org/C2780385302","wikidata":"https://www.wikidata.org/wiki/Q367158","display_name":"Protocol (science)","level":3,"score":0.679842472076416},{"id":"https://openalex.org/C2777106319","wikidata":"https://www.wikidata.org/wiki/Q362104","display_name":"Institutional review board","level":2,"score":0.5433072447776794},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5387324690818787},{"id":"https://openalex.org/C2777921204","wikidata":"https://www.wikidata.org/wiki/Q66104672","display_name":"Knowledge translation","level":2,"score":0.5179159045219421},{"id":"https://openalex.org/C189708586","wikidata":"https://www.wikidata.org/wiki/Q1504425","display_name":"Systematic review","level":3,"score":0.5015053749084473},{"id":"https://openalex.org/C153997805","wikidata":"https://www.wikidata.org/wiki/Q42240","display_name":"Research ethics","level":2,"score":0.4876329004764557},{"id":"https://openalex.org/C2779318504","wikidata":"https://www.wikidata.org/wiki/Q1438035","display_name":"Research design","level":2,"score":0.48593392968177795},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.4279877841472626},{"id":"https://openalex.org/C128544194","wikidata":"https://www.wikidata.org/wiki/Q474859","display_name":"Translational research","level":2,"score":0.4219732880592346},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.41251906752586365},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.40289056301116943},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.3535439372062683},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.35204601287841797},{"id":"https://openalex.org/C509550671","wikidata":"https://www.wikidata.org/wiki/Q126945","display_name":"Medical education","level":1,"score":0.3376600444316864},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.2503076195716858},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.17851755023002625},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.13528123497962952},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.12161681056022644},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.10978773236274719},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.0},{"id":"https://openalex.org/C144024400","wikidata":"https://www.wikidata.org/wiki/Q21201","display_name":"Sociology","level":0,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C36289849","wikidata":"https://www.wikidata.org/wiki/Q34749","display_name":"Social science","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000078202","descriptor_name":"Systematic Reviews as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002648","descriptor_name":"Child","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002985","descriptor_name":"Clinical Protocols","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000941","qualifier_name":"ethics","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","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":"D017144","descriptor_name":"Focus Groups","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D057170","descriptor_name":"Translational Research, Biomedical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":7,"locations":[{"id":"doi:10.1186/s13063-018-2934-7","doi":"https://doi.org/10.1186/s13063-018-2934-7","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s13063-018-2934-7","pdf_url":"https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-018-2934-7","source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},{"id":"pmh:oai:europepmc.org:5150177","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6194696","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":null,"raw_type":"Text"},{"id":"pmid:30340624","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/30340624","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":"Trials","raw_type":"Journal Article"},{"id":"pmh:oai:pubmedcentral.nih.gov:6194696","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC6194696/","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"Text"},{"id":"pmh:oai:doaj.org/article:500a962e20c4446585018bef356b0165","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/500a962e20c4446585018bef356b0165","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Trials, Vol 19, Iss 1, Pp 1-9 (2018)","raw_type":"article"},{"id":"pmh:oai:mspace.lib.umanitoba.ca:1993/33546","doi":null,"is_oa":false,"landing_page_url":"http://hdl.handle.net/1993/33546","pdf_url":null,"source":{"id":"https://openalex.org/S4306400554","display_name":"Mspace (University of Manitoba)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I46247651","host_organization_name":"University of Manitoba","host_organization_lineage":["https://openalex.org/I46247651"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Journal Article"},{"id":"pmh:oai:mspace.lib.umanitoba.ca:1993/36502","doi":null,"is_oa":false,"landing_page_url":"http://hdl.handle.net/1993/36502","pdf_url":null,"source":{"id":"https://openalex.org/S4306400554","display_name":"Mspace (University of Manitoba)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I46247651","host_organization_name":"University of Manitoba","host_organization_lineage":["https://openalex.org/I46247651"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"other"}],"best_oa_location":{"id":"doi:10.1186/s13063-018-2934-7","doi":"https://doi.org/10.1186/s13063-018-2934-7","is_oa":true,"landing_page_url":"https://doi.org/10.1186/s13063-018-2934-7","pdf_url":"https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-018-2934-7","source":{"id":"https://openalex.org/S109512841","display_name":"Trials","issn_l":"1745-6215","issn":["1745-6215"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","oarl","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Trials","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9476000070571899,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/study-protocol","display_name":"Study Protocol"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320314151","display_name":"Kidscan Children's Cancer Research","ror":"https://ror.org/04kqvks84"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2896532728.pdf","grobid_xml":"https://content.openalex.org/works/W2896532728.grobid-xml"},"referenced_works_count":42,"referenced_works":["https://openalex.org/W126774542","https://openalex.org/W1496830972","https://openalex.org/W1533707383","https://openalex.org/W1556808170","https://openalex.org/W1560713859","https://openalex.org/W1601164041","https://openalex.org/W1658908529","https://openalex.org/W1731081963","https://openalex.org/W1966204708","https://openalex.org/W1985466152","https://openalex.org/W2008929902","https://openalex.org/W2030526274","https://openalex.org/W2032679215","https://openalex.org/W2044439361","https://openalex.org/W2053328440","https://openalex.org/W2056144694","https://openalex.org/W2069224738","https://openalex.org/W2082770695","https://openalex.org/W2086023966","https://openalex.org/W2093274439","https://openalex.org/W2098923148","https://openalex.org/W2122527560","https://openalex.org/W2127023478","https://openalex.org/W2142582365","https://openalex.org/W2144769476","https://openalex.org/W2148148407","https://openalex.org/W2161374186","https://openalex.org/W2161966436","https://openalex.org/W2166890809","https://openalex.org/W2171364060","https://openalex.org/W2184895054","https://openalex.org/W2282520777","https://openalex.org/W2299177375","https://openalex.org/W2301701445","https://openalex.org/W2327303566","https://openalex.org/W2331393505","https://openalex.org/W2390008750","https://openalex.org/W2425415624","https://openalex.org/W2496650185","https://openalex.org/W2588681363","https://openalex.org/W3214833809","https://openalex.org/W6664729310"],"related_works":["https://openalex.org/W4390690845","https://openalex.org/W4403112191","https://openalex.org/W3192943571","https://openalex.org/W2018266072","https://openalex.org/W4376872852","https://openalex.org/W7221507882","https://openalex.org/W7118089875","https://openalex.org/W3036354474","https://openalex.org/W2791409969","https://openalex.org/W2921164479"],"abstract_inverted_index":{"BACKGROUND:":[0],"Although":[1],"children":[2,225],"have":[3,90,339],"historically":[4],"been":[5],"excluded":[6],"from":[7,207],"clinical":[8,330],"trials":[9,223],"(CTs),":[10],"many":[11,84],"require":[12,44],"medicines":[13,352],"tested":[14],"and":[15,39,41,93,118,125,128,171,178,190,201,210,217,226,248,252,266,270,272,277,297,317,348],"approved":[16],"in":[17,109,133,145,161,219,222,244,327,353],"CTs,":[18],"forcing":[19],"health":[20,334],"care":[21,335],"providers":[22,336],"to":[23,58,70,106,139,303,341],"treat":[24],"their":[25],"pediatric":[26,63,110,245],"patients":[27],"based":[28],"on":[29,159,167,229,239],"extrapolated":[30],"data.":[31],"Unfortunately,":[32],"traditional":[33],"randomized":[34],"CTs":[35,54,64,134,162],"can":[36,300],"be":[37,56,137,164,183,301],"slow":[38],"resource-intensive,":[40],"they":[42,274,338],"often":[43],"multi-center":[45],"collaboration.":[46],"However,":[47],"an":[48],"adaptive":[49],"design":[50,180],"(AD)":[51],"framework":[52],"for":[53,320],"could":[55,136],"used":[57,138,302],"increase":[59],"the":[60,75,80,120,141,149,211,215,240,261,291,313,346],"efficiency":[61],"of":[62,79,131,143,151,242,263,284,351],"by":[65,279,333],"incorporating":[66],"prospectively":[67],"planned":[68],"modifications":[69],"CT":[71,111],"methods":[72],"without":[73],"undermining":[74],"integrity":[76],"or":[77],"validity":[78],"study.":[81],"There":[82],"are":[83],"possible":[85],"adaptations,":[86],"but":[87],"each":[88],"will":[89,104,115,163,182,213,235,255,289,325],"ethical,":[91,123,169],"logistical,":[92,124],"statistical":[94,126,172],"implications.":[95],"It":[96],"remains":[97],"unclear":[98],"which":[99],"adaptations":[100],"(or":[101],"combinations":[102],"thereof)":[103],"lead":[105],"real-world":[107],"improvements":[108],"efficiency.":[112],"This":[113,233],"study":[114,187,234],"identify,":[116],"evaluate,":[117],"synthesize":[119],"various":[121],"regulatory,":[122,168],"considerations":[127,173],"emerging":[129],"issues":[130],"AD":[132,160,221,243,299],"that":[135,257,273],"evaluate":[140,214],"use":[142,241,350],"drugs":[144],"children.":[146,354],"METHODS/DESIGN:":[147],"Following":[148],"development":[150],"a":[152,156,281],"peer-reviewed":[153],"search":[154],"strategy,":[155],"systematic":[157],"review":[158],"conducted.":[165],"Data":[166],"logistic,":[170],"as":[174,176,203,205],"well":[175,204],"population":[177],"trial":[179],"characteristics":[181],"synthesized.":[184],"A":[185],"mixed-methods":[186],"including":[188],"surveys":[189],"focus":[191],"groups":[192,209],"with":[193,250,307],"regulators,":[194,265],"research":[195,288,305,331],"ethics":[196],"board":[197],"members,":[198],"biostatisticians,":[199],"clinicians,":[200],"scientists,":[202],"representatives":[206],"patient":[208],"public":[212],"opportunities":[216],"challenges":[218],"applying":[220],"enrolling":[224],"propose":[227],"recommendations":[228,238],"best":[230],"practices.":[231],"DISCUSSION:":[232],"deliver":[236],"practical":[237],"CTs.":[246,321],"Collaboration":[247],"consultation":[249],"national":[251],"global":[253],"partners":[254],"ensure":[256],"our":[258],"results":[259],"meet":[260],"needs":[262],"researchers,":[264],"patients,":[267],"both":[268],"locally":[269],"globally,":[271],"remain":[275],"current":[276],"relevant":[278],"engaging":[280],"wide":[282],"variety":[283],"stakeholders.":[285],"Overall,":[286],"this":[287,324],"enrich":[290],"knowledge":[292],"base":[293],"regarding":[294,345],"if,":[295],"how,":[296],"when":[298],"answer":[304],"questions":[306],"fewer":[308],"resources":[309],"while":[310],"still":[311],"meeting":[312],"highest":[314],"ethical":[315],"standards":[316],"regulatory":[318],"requirements":[319],"In":[322],"turn,":[323],"result":[326],"increased":[328],"high-quality":[329],"needed":[332],"so":[337],"access":[340],"appropriate,":[342],"population-specific":[343],"evidence":[344],"safe":[347],"effective":[349]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":7},{"year":2023,"cited_by_count":3},{"year":2021,"cited_by_count":3},{"year":2020,"cited_by_count":3},{"year":2019,"cited_by_count":1}],"updated_date":"2026-11-10T11:39:43.021295","created_date":"2018-10-26T00:00:00"}