{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T21:07:13Z","timestamp":1740172033111,"version":"3.37.3"},"reference-count":13,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.tandfonline.com"],"crossmark-restriction":true},"short-container-title":["Journal of Market Access &amp; Health Policy"],"published-print":{"date-parts":[[2018,1]]},"DOI":"10.1080\/20016689.2018.1542920","type":"journal-article","created":{"date-parts":[[2018,11,7]],"date-time":"2018-11-07T23:41:17Z","timestamp":1541634077000},"page":"1542920","update-policy":"https:\/\/doi.org\/10.1080\/tandf_crossmark_01","source":"Crossref","is-referenced-by-count":11,"title":["Patient-reported outcome claims in European and United States orphan drug approvals"],"prefix":"10.3390","volume":"6","author":[{"given":"Szymon","family":"Jaros\u0142awski","sequence":"first","affiliation":[{"name":"Public Health Department \u2013 Research Unit EA 3279, Aix \u2013 Marseille University, Marseille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pascal","family":"Auquier","sequence":"additional","affiliation":[{"name":"Public Health Department \u2013 Research Unit EA 3279, Aix \u2013 Marseille University, Marseille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Borislav","family":"Borissov","sequence":"additional","affiliation":[{"name":"Prescriptia Ltd., Sofia, Bulgaria"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claude","family":"Dussart","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine Laennec, Claude Bernard University, Laboratoire Parcours Sant\u00e9 Syst\u00e9mique EA 4129, Universit\u00e9 de Lyon, Lyon, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7939-7204","authenticated-orcid":false,"given":"Mondher","family":"Toumi","sequence":"additional","affiliation":[{"name":"Public Health Department \u2013 Research Unit EA 3279, Aix \u2013 Marseille University, Marseille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2018,11,7]]},"reference":[{"volume-title":"Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products","year":"2005","author":"European Medicines Agency(EMA)","key":"CIT0001"},{"volume-title":"US food and drug administration guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims","year":"2009","key":"CIT0002"},{"key":"CIT0003","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.jval.2010.11.004","volume":"14","author":"Patrick DL","year":"2011","journal-title":"Value Health"},{"volume-title":"Orphan designation","key":"CIT0004"},{"key":"CIT0005","unstructured":"European Medicines Agency.Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. London: European Medicines Agency; 2005."},{"volume-title":"Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (PRO) measures in oncology studies","year":"2016","author":"European Medicines Agency","key":"CIT0006"},{"key":"CIT0007","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.11.032"},{"key":"CIT0008","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-010-9793-3"},{"key":"CIT0009","volume":"6","author":"Jaros\u0142awski S","year":"2018","journal-title":"J Market Access Health Policy"},{"key":"CIT0010","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2016.03.1950"},{"key":"CIT0011","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2013.08.2293"},{"key":"CIT0012","doi-asserted-by":"publisher","DOI":"10.1016\/j.jegh.2015.04.006"},{"key":"CIT0013","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-014-2892-z"}],"container-title":["Journal of Market Access &amp; Health Policy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.1080\/20016689.2018.1542920","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.1080\/20016689.2018.1542920","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,18]],"date-time":"2024-01-18T09:02:38Z","timestamp":1705568558000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/search?q=10.1080\/20016689.2018.1542920"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1]]},"references-count":13,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2018,1,18]]},"published-print":{"date-parts":[[2018,1]]}},"alternative-id":["10.1080\/20016689.2018.1542920"],"URL":"https:\/\/doi.org\/10.1080\/20016689.2018.1542920","relation":{},"ISSN":["2001-6689"],"issn-type":[{"type":"electronic","value":"2001-6689"}],"subject":[],"published":{"date-parts":[[2018,1]]},"assertion":[{"value":"The publishing and review policy for this title is described in its Aims & Scope.","order":1,"name":"peerreview_statement","label":"Peer Review Statement"},{"value":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=zjma20","URL":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=zjma20","order":2,"name":"aims_and_scope_url","label":"Aim & Scope"},{"value":"2018-05-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-23","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-10-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-11-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}