{"id":"https://openalex.org/W4409502575","doi":"https://doi.org/10.1002/cpt.3684","title":"Supplementing Single\u2010Arm Trials with External Control Arms\u2014Evaluation of German Real\u2010World Data","display_name":"Supplementing Single\u2010Arm Trials with External Control Arms\u2014Evaluation of German Real\u2010World Data","publication_year":2025,"publication_date":"2025-04-16","ids":{"openalex":"https://openalex.org/W4409502575","doi":"https://doi.org/10.1002/cpt.3684","pmid":"https://pubmed.ncbi.nlm.nih.gov/40237254"},"language":"en","primary_location":{"id":"doi:10.1002/cpt.3684","doi":"https://doi.org/10.1002/cpt.3684","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpt.3684","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpt.3684","source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology & Therapeutics","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpt.3684","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5037690184","display_name":"Martin Russek","orcid":"https://orcid.org/0009-0007-9509-0342","observed_orcids":["https://orcid.org/0009-0007-9509-0342"]},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"funder","lineage":["https://openalex.org/I123859907"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Martin Russek","raw_affiliation_strings":["Research Division, Pharmacoepidemiology Federal Institute for Drugs and Medical Devices (BfArM)  Bonn Germany"],"raw_orcid":"https://orcid.org/0009-0007-9509-0342","affiliations":[{"raw_affiliation_string":"Research Division, Pharmacoepidemiology Federal Institute for Drugs and Medical Devices (BfArM)  Bonn Germany","institution_ids":["https://openalex.org/I123859907"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5115825590","display_name":"Jonas Peltner","orcid":"https://orcid.org/0000-0002-1682-7913","observed_orcids":["https://orcid.org/0000-0002-1682-7913"]},"institutions":[{"id":"https://openalex.org/I2801533059","display_name":"German Center for Neurodegenerative Diseases","ror":"https://ror.org/043j0f473","country_code":"DE","type":"facility","lineage":["https://openalex.org/I1305996414","https://openalex.org/I2801533059","https://openalex.org/I4405256427"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Jonas Peltner","raw_affiliation_strings":["Pharmacoepidemiology in Neurodegenerative Disorders German Center for Neurodegenerative Diseases (DZNE)  Bonn Germany"],"raw_orcid":"https://orcid.org/0000-0002-1682-7913","affiliations":[{"raw_affiliation_string":"Pharmacoepidemiology in Neurodegenerative Disorders German Center for Neurodegenerative Diseases (DZNE)  Bonn Germany","institution_ids":["https://openalex.org/I2801533059"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5019907310","display_name":"Britta Haenisch","orcid":"https://orcid.org/0000-0002-4828-6058","observed_orcids":["https://orcid.org/0000-0002-4828-6058"]},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"funder","lineage":["https://openalex.org/I123859907"]},{"id":"https://openalex.org/I135140700","display_name":"University of Bonn","ror":"https://ror.org/041nas322","country_code":"DE","type":"education","lineage":["https://openalex.org/I135140700"]},{"id":"https://openalex.org/I2801533059","display_name":"German Center for Neurodegenerative Diseases","ror":"https://ror.org/043j0f473","country_code":"DE","type":"facility","lineage":["https://openalex.org/I1305996414","https://openalex.org/I2801533059","https://openalex.org/I4405256427"]}],"countries":["DE"],"is_corresponding":true,"raw_author_name":"Britta Haenisch","raw_affiliation_strings":["Pharmacoepidemiology in Neurodegenerative Disorders German Center for Neurodegenerative Diseases (DZNE)  Bonn Germany","Research Division, Pharmacoepidemiology Federal Institute for Drugs and Medical Devices (BfArM)  Bonn Germany","University of Bonn Center for Translational Medicine  Bonn Germany"],"raw_orcid":"https://orcid.org/0000-0002-4828-6058","affiliations":[{"raw_affiliation_string":"Pharmacoepidemiology in Neurodegenerative Disorders German Center for Neurodegenerative Diseases (DZNE)  Bonn Germany","institution_ids":["https://openalex.org/I2801533059"]},{"raw_affiliation_string":"Research Division, Pharmacoepidemiology Federal Institute for Drugs and Medical Devices (BfArM)  Bonn Germany","institution_ids":["https://openalex.org/I123859907"]},{"raw_affiliation_string":"University of Bonn Center for Translational Medicine  Bonn Germany","institution_ids":["https://openalex.org/I135140700"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5019907310"],"corresponding_institution_ids":["https://openalex.org/I123859907","https://openalex.org/I135140700","https://openalex.org/I2801533059"],"apc_list":{"value":4410,"currency":"USD","value_usd":4410},"apc_paid":{"value":4410,"currency":"USD","value_usd":4410},"fwci":3.342,"has_fulltext":true,"cited_by_count":4,"citation_normalized_percentile":{"value":0.92514587,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":90,"max":98},"biblio":{"volume":"118","issue":"6","first_page":"1443","last_page":"1450"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9937000274658203,"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":0.9937000274658203,"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":0.0010000000474974513,"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/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.0006000000284984708,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/external-control-arm","display_name":"external control arm","score":0.8769999742507935},{"id":"https://openalex.org/keywords/real-world-data","display_name":"real-world data","score":0.9980000257492065},{"id":"https://openalex.org/keywords/breast-cancer","display_name":"breast cancer","score":0.9139999747276306},{"id":"https://openalex.org/keywords/amyotrophic-lateral-sclerosis","display_name":"amyotrophic lateral sclerosis","score":1.0},{"id":"https://openalex.org/keywords/eligibility-criteria","display_name":"eligibility criteria","score":0.8709999918937683},{"id":"https://openalex.org/keywords/primary-endpoint","display_name":"primary endpoint","score":0.8759999871253967}],"concepts":[{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.6508206129074097},{"id":"https://openalex.org/C174106493","wikidata":"https://www.wikidata.org/wiki/Q1057880","display_name":"External validity","level":2,"score":0.5781188607215881},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5694496035575867},{"id":"https://openalex.org/C530470458","wikidata":"https://www.wikidata.org/wiki/Q128581","display_name":"Breast cancer","level":3,"score":0.5564101934432983},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5540491938591003},{"id":"https://openalex.org/C2910001868","wikidata":"https://www.wikidata.org/wiki/Q458","display_name":"European union","level":2,"score":0.4505015015602112},{"id":"https://openalex.org/C154775046","wikidata":"https://www.wikidata.org/wiki/Q188","display_name":"German","level":2,"score":0.42832285165786743},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.30404049158096313},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.2560684084892273},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.2529887557029724},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.15681993961334229},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.0},{"id":"https://openalex.org/C166957645","wikidata":"https://www.wikidata.org/wiki/Q23498","display_name":"Archaeology","level":1,"score":0.0},{"id":"https://openalex.org/C95457728","wikidata":"https://www.wikidata.org/wiki/Q309","display_name":"History","level":0,"score":0.0},{"id":"https://openalex.org/C105639569","wikidata":"https://www.wikidata.org/wiki/Q582577","display_name":"Economic policy","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000690","descriptor_name":"Amyotrophic Lateral Sclerosis","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D000690","descriptor_name":"Amyotrophic Lateral Sclerosis","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D000690","descriptor_name":"Amyotrophic Lateral Sclerosis","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D000690","descriptor_name":"Amyotrophic Lateral Sclerosis","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D001943","descriptor_name":"Breast Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D001943","descriptor_name":"Breast Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D001943","descriptor_name":"Breast Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D001943","descriptor_name":"Breast Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005858","descriptor_name":"Germany","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005858","descriptor_name":"Germany","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005858","descriptor_name":"Germany","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005858","descriptor_name":"Germany","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":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012042","descriptor_name":"Registries","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":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":4,"locations":[{"id":"doi:10.1002/cpt.3684","doi":"https://doi.org/10.1002/cpt.3684","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpt.3684","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpt.3684","source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology & Therapeutics","raw_type":"journal-article"},{"id":"pmid:40237254","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/40237254","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":"Clinical pharmacology and therapeutics","raw_type":"Journal Article"},{"id":"pmh:oai:pub.dzne.de:282544","doi":null,"is_oa":true,"landing_page_url":"https://pub.dzne.de/record/282544","pdf_url":"https://pub.dzne.de/record/282544/files/DZNE-2025-01307.pdf","source":{"id":"https://openalex.org/S7407051172","display_name":"DZNE Pub","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2801533059","host_organization_name":"German Center for Neurodegenerative Diseases","host_organization_lineage":["https://openalex.org/I2801533059"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Clinical pharmacology & therapeutics 118(6), 1443 - 1450 (2025). doi:10.1002/cpt.3684","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:europepmc.org:11447898","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/12641071","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":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1002/cpt.3684","doi":"https://doi.org/10.1002/cpt.3684","is_oa":true,"landing_page_url":"https://doi.org/10.1002/cpt.3684","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cpt.3684","source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology & Therapeutics","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9763000011444092,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[{"score":0.550000011920929,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4409502575.pdf","grobid_xml":"https://content.openalex.org/works/W4409502575.grobid-xml"},"referenced_works_count":23,"referenced_works":["https://openalex.org/W2009187570","https://openalex.org/W2015018745","https://openalex.org/W2149965232","https://openalex.org/W2582743722","https://openalex.org/W2915688785","https://openalex.org/W2979670403","https://openalex.org/W3049212519","https://openalex.org/W3175407676","https://openalex.org/W3213534936","https://openalex.org/W4205535987","https://openalex.org/W4254687493","https://openalex.org/W4322757732","https://openalex.org/W4366819824","https://openalex.org/W4387391899","https://openalex.org/W4389504862","https://openalex.org/W4393558097","https://openalex.org/W4393950365","https://openalex.org/W4396228487","https://openalex.org/W4398794208","https://openalex.org/W4402580728","https://openalex.org/W4408062070","https://openalex.org/W6878158550","https://openalex.org/W6911129260"],"related_works":["https://openalex.org/W2315527029","https://openalex.org/W2065387230","https://openalex.org/W2323937687","https://openalex.org/W648995381","https://openalex.org/W3033791384","https://openalex.org/W2141885522","https://openalex.org/W2776312268","https://openalex.org/W4246315097","https://openalex.org/W346029495","https://openalex.org/W1201259214"],"abstract_inverted_index":{"As":[0],"single-arm":[1],"trials":[2,71,158,171,184],"(SATs)":[3],"are":[4],"increasingly":[5],"used":[6],"in":[7,87,105,151,165,178,192,203,227,249],"pharmaceutical":[8],"research,":[9],"the":[10,23,37,66,106,152,228,232,244],"validity":[11],"of":[12,25,39,70,89,118,125,225,243,246],"such":[13],"study":[14,208],"designs":[15],"needs":[16],"to":[17,148,221],"be":[18,59,85,131,149,219,239],"critically":[19],"assessed.":[20],"We":[21,94],"characterize":[22],"feasibility":[24],"supplementing":[26],"SATs":[27,40,97,122,128,211,237],"with":[28,133,212,241],"real-world":[29],"data":[30],"(RWD)-derived":[31],"external":[32,52,135,214,247],"control":[33,53,136,215],"arms":[34,216],"by":[35],"determining":[36],"proportion":[38],"on":[41,56],"breast":[42,99,120,156],"cancer":[43,100,121,157],"and":[44,68,78,114,123,143,169,195,235],"amyotrophic":[45],"lateral":[46],"sclerosis":[47],"(ALS)":[48],"for":[49,72,231],"which":[50,73],"an":[51],"arm":[54],"based":[55],"RWD":[57,92,153,167,180,193,205],"can":[58],"constructed.":[60],"The":[61],"main":[62],"outcome":[63,163],"measure":[64],"is":[65],"number":[67],"percentage":[69],"all":[74,96,139,173,198],"important":[75,140,174,199],"eligibility":[76,141,175,200],"criteria":[77,142,176,201],"at":[79,160,186],"least":[80,161,187],"one":[81,88,162,188],"primary":[82,145,189],"endpoint":[83,146,190],"could":[84,129],"identified":[86],"five":[90],"German":[91],"sources.":[93],"surveyed":[95],"concerning":[98],"or":[101],"ALS":[102,127,183],"treatment":[103,223],"registered":[104],"European":[107],"Union's":[108],"clinical":[109],"trial":[110],"registers":[111],"between":[112],"2004":[113],"2023.":[115],"Ten":[116],"out":[117],"379":[119],"2":[124,196],"11":[126],"feasibly":[130],"supplemented":[132],"RWD-derived":[134,213],"arms,":[137],"if":[138],"a":[144,166,179,204],"have":[147],"identifiable":[150],"source.":[154,181,206],"Ninety-three":[155],"had":[159,172,185,197],"ascertainable":[164,191],"source,":[168],"35":[170],"recorded":[177,202],"Nine":[182],"sources,":[194],"Our":[207],"shows":[209],"that":[210,236],"will":[217],"rarely":[218],"suitable":[220],"establish":[222],"effects":[224],"medicines":[226],"current":[229],"setting":[230],"investigated":[233],"phenotypes":[234],"should":[238],"designed":[240],"limitations":[242],"source":[245],"controls":[248],"mind.":[250]},"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2025,"cited_by_count":1}],"updated_date":"2026-10-14T16:39:01.820549","created_date":"2025-10-10T00:00:00"}