{"id":"https://openalex.org/W2090432028","doi":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","title":"Health-Related Quality of Life and Other Patient-Reported Outcomes in the European Centralized Drug Regulatory Process: A Review of Guidance Documents and Performed Authorizations of Medicinal Products 1995 to 2003","display_name":"Health-Related Quality of Life and Other Patient-Reported Outcomes in the European Centralized Drug Regulatory Process: A Review of Guidance Documents and Performed Authorizations of Medicinal Products 1995 to 2003","publication_year":2005,"publication_date":"2005-09-01","ids":{"openalex":"https://openalex.org/W2090432028","doi":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","mag":"2090432028","pmid":"https://pubmed.ncbi.nlm.nih.gov/16176492"},"language":"en","primary_location":{"id":"doi:10.1111/j.1524-4733.2005.00051.x","doi":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","is_oa":true,"landing_page_url":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","pdf_url":null,"source":{"id":"https://openalex.org/S678965","display_name":"Value in Health","issn_l":"1098-3015","issn":["1098-3015","1524-4733"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Value in Health","raw_type":"journal-article"},"volume":null,"type":"review","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5002095623","display_name":"\u00c1gota Szende","orcid":"https://orcid.org/0000-0002-5880-3354","observed_orcids":["https://orcid.org/0000-0002-5880-3354"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"\u00c1gota Szende","raw_affiliation_strings":["Covance Health Economics and Outcomes Services, London, UK. szende@covance.com","Covance Health Economics and Outcomes Services, London, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Covance Health Economics and Outcomes Services, London, UK. szende@covance.com","institution_ids":[]},{"raw_affiliation_string":"Covance Health Economics and Outcomes Services, London, UK","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5110595312","display_name":"Nancy Kline Leidy","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Nancy K. Leidy","raw_affiliation_strings":["MEDTAP International, Bethesda MD, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MEDTAP International, Bethesda MD, USA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5001054264","display_name":"Dennis A. Revicki","orcid":"https://orcid.org/0000-0001-6780-0019","observed_orcids":["https://orcid.org/0000-0001-6780-0019"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Dennis Revicki","raw_affiliation_strings":["MEDTAP International, Bethesda MD, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"MEDTAP International, Bethesda MD, USA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":4000,"currency":"USD","value_usd":4000},"apc_paid":null,"fwci":2.6371,"has_fulltext":false,"cited_by_count":55,"citation_normalized_percentile":{"value":0.87443946,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"8","issue":"5","first_page":"534","last_page":"548"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9940999746322632,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9940999746322632,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.002400000113993883,"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/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.000699999975040555,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/health-related-quality-of-life","display_name":"health-related quality of life","score":0.9990000128746033},{"id":"https://openalex.org/keywords/patient-reported-outcomes","display_name":"patient-reported outcomes","score":0.9990000128746033},{"id":"https://openalex.org/keywords/drug-approval","display_name":"drug approval","score":0.5389999747276306},{"id":"https://openalex.org/keywords/european-medicines-agency","display_name":"European Medicines Agency","score":0.8920000195503235},{"id":"https://openalex.org/keywords/regulatory-guidance-documents","display_name":"regulatory guidance documents","score":0.8489999771118164},{"id":"https://openalex.org/keywords/european-public-assessment-reports","display_name":"European Public Assessment Reports","score":0.9129999876022339},{"id":"https://openalex.org/keywords/primary-endpoint","display_name":"primary endpoint","score":0.5680000185966492},{"id":"https://openalex.org/keywords/cancer-therapy","display_name":"cancer therapy","score":0.5139999985694885},{"id":"https://openalex.org/keywords/regulatory-decision-making","display_name":"regulatory decision-making","score":0.5770000219345093},{"id":"https://openalex.org/keywords/clinical-trial-endpoints","display_name":"clinical trial endpoints","score":0.4449999928474426}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.728486955165863},{"id":"https://openalex.org/C56666940","wikidata":"https://www.wikidata.org/wiki/Q788790","display_name":"Documentation","level":2,"score":0.6175270676612854},{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.5917621850967407},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5645582675933838},{"id":"https://openalex.org/C2778012447","wikidata":"https://www.wikidata.org/wiki/Q1034415","display_name":"Scope (computer science)","level":2,"score":0.5360674262046814},{"id":"https://openalex.org/C2777589142","wikidata":"https://www.wikidata.org/wiki/Q6770899","display_name":"Marketing authorization","level":2,"score":0.5345743298530579},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.49746182560920715},{"id":"https://openalex.org/C108170787","wikidata":"https://www.wikidata.org/wiki/Q3951828","display_name":"Agency (philosophy)","level":2,"score":0.46512293815612793},{"id":"https://openalex.org/C2779951463","wikidata":"https://www.wikidata.org/wiki/Q7268788","display_name":"Quality of life (healthcare)","level":2,"score":0.4392673969268799},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.42662250995635986},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.4152088761329651},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.17354899644851685},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.11156189441680908},{"id":"https://openalex.org/C60644358","wikidata":"https://www.wikidata.org/wiki/Q128570","display_name":"Bioinformatics","level":1,"score":0.1027975082397461},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D002908","descriptor_name":"Chronic Disease","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D002908","descriptor_name":"Chronic Disease","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D002908","descriptor_name":"Chronic Disease","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D004341","descriptor_name":"Drug Evaluation","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D004341","descriptor_name":"Drug Evaluation","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D004341","descriptor_name":"Drug Evaluation","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005062","descriptor_name":"European Union","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005062","descriptor_name":"European Union","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005062","descriptor_name":"European Union","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":"D007407","descriptor_name":"Interviews as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007407","descriptor_name":"Interviews as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007407","descriptor_name":"Interviews as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011307","descriptor_name":"Drug Prescriptions","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D011307","descriptor_name":"Drug Prescriptions","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D011307","descriptor_name":"Drug Prescriptions","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D011788","descriptor_name":"Quality of Life","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011788","descriptor_name":"Quality of Life","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011788","descriptor_name":"Quality of Life","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000191","qualifier_name":"economics","is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D018434","descriptor_name":"Sickness Impact Profile","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018434","descriptor_name":"Sickness Impact Profile","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018434","descriptor_name":"Sickness Impact Profile","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1111/j.1524-4733.2005.00051.x","doi":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","is_oa":true,"landing_page_url":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","pdf_url":null,"source":{"id":"https://openalex.org/S678965","display_name":"Value in Health","issn_l":"1098-3015","issn":["1098-3015","1524-4733"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Value in Health","raw_type":"journal-article"},{"id":"pmid:16176492","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/16176492","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":"Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1111/j.1524-4733.2005.00051.x","doi":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","is_oa":true,"landing_page_url":"https://doi.org/10.1111/j.1524-4733.2005.00051.x","pdf_url":null,"source":{"id":"https://openalex.org/S678965","display_name":"Value in Health","issn_l":"1098-3015","issn":["1098-3015","1524-4733"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Value in Health","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.98580002784729,"display_name":"Good health and well-being"}],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/16","score":0.5,"display_name":"Peace, justice, and strong institutions"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320307758","display_name":"Eli Lilly and Company","ror":"https://ror.org/01qat3289"},{"id":"https://openalex.org/F4320307765","display_name":"Pfizer","ror":"https://ror.org/01xdqrp08"},{"id":"https://openalex.org/F4320307776","display_name":"Merck","ror":"https://ror.org/02891sr49"},{"id":"https://openalex.org/F4320307778","display_name":"Novartis","ror":"https://ror.org/02f9zrr09"},{"id":"https://openalex.org/F4320307779","display_name":"Roche","ror":"https://ror.org/00by1q217"},{"id":"https://openalex.org/F4320307781","display_name":"Sanofi","ror":"https://ror.org/027vj4x92"},{"id":"https://openalex.org/F4320307785","display_name":"3M","ror":"https://ror.org/00mgss748"},{"id":"https://openalex.org/F4320309517","display_name":"Schering-Plough","ror":"https://ror.org/02891sr49"},{"id":"https://openalex.org/F4320322436","display_name":"Novo Nordisk","ror":"https://ror.org/0435rc536"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":9,"referenced_works":["https://openalex.org/W1537544985","https://openalex.org/W1596753163","https://openalex.org/W1958971206","https://openalex.org/W1990411699","https://openalex.org/W1992426411","https://openalex.org/W2029803893","https://openalex.org/W2094101973","https://openalex.org/W2099563036","https://openalex.org/W2111869225"],"related_works":["https://openalex.org/W132947955","https://openalex.org/W2142713918","https://openalex.org/W2072826728","https://openalex.org/W2081491699","https://openalex.org/W2109437062","https://openalex.org/W1990411699","https://openalex.org/W4311334639","https://openalex.org/W2145751505","https://openalex.org/W2099563036","https://openalex.org/W356399836"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2023,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2020,"cited_by_count":8},{"year":2017,"cited_by_count":3},{"year":2016,"cited_by_count":4},{"year":2015,"cited_by_count":2},{"year":2014,"cited_by_count":4},{"year":2013,"cited_by_count":4},{"year":2012,"cited_by_count":1}],"updated_date":"2026-10-27T15:51:10.671819","created_date":"2016-06-24T00:00:00"}
