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The 10 most frequently on\u2010label prescribed drug classes, drugs with known pharmacokinetic differences in the elderly or drugs that are relatively contraindicated in elderly (e.g. anticholinergics or benzodiazepines) were included in the analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total, 1129 unique active pharmaceutical ingredients were found eligible for the analyses, of these, 506 were found in the Food and Drug Administration database (45%). The initial approval documents were available for 182 drugs. For the majority of the drugs, the initial approval documents in the database showed information on pharmacokinetics in elderly (<jats:italic>n<\/jats:italic>\u00a0=\u00a0113; 62%). Furthermore, over time, the availability of information with regard to elderly increased statistically significantly from 0% in the period 1970\u20131979 to 76% for the period 2010\u20132018. Information on safety and efficacy was less frequently present, i.e. 42% and 45%, respectively and, moreover, the availability of information did not improve over time.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The under\u2010representation of elderly in clinical trials thereby challenging the external validity of benefit\/risk assessments of launched drugs was confirmed. Priority should be given to a study population that is representative for the target population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13876","type":"journal-article","created":{"date-parts":[[2019,1,25]],"date-time":"2019-01-25T12:08:52Z","timestamp":1548418132000},"page":"838-844","source":"Crossref","is-referenced-by-count":69,"title":["Under\u2010representation of elderly in clinical trials: An analysis of the initial approval documents in the Food and Drug Administration database"],"prefix":"10.1111","volume":"85","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7563-2019","authenticated-orcid":false,"given":"Rikje","family":"Ruiter","sequence":"first","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"},{"name":"Department of Epidemiology Erasmus MC  Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacobus","family":"Burggraaf","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"},{"name":"Leiden University Medical Centre  Leiden the Netherlands"},{"name":"Leiden Academic Center for Drug Research  Leiden the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5867-9090","authenticated-orcid":false,"given":"Robert","family":"Rissmann","sequence":"additional","affiliation":[{"name":"Centre for Human Drug Research  Leiden the Netherlands"},{"name":"Leiden University Medical Centre  Leiden the Netherlands"},{"name":"Leiden Academic Center for Drug Research  Leiden the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,2,23]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"European Commission Directorate\u2010General for Economic and Financial Affairs.The 2015 Ageing Report Economic and budgetary projections for the 28 EU Member States (2013\u20132060).2015.https:\/\/doi.org\/10.27658\/77631"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d3815"},{"key":"e_1_2_9_4_1","doi-asserted-by":"crossref","unstructured":"UN\u2010DESA \u2010 The World Bank.World Population Prospects The 2017 Revision Key Findings and Advance Tables. 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