{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T04:16:47Z","timestamp":1790482607566,"version":"4.1.0"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000071","name":"National Institute of Child Health and Human Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000071","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,3,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Cytomegalovirus (CMV) remains an important pathogen in the transplant population. As such, the US Food and Drug Administration has published a guidance to encourage and inform the development of therapeutics for the treatment and prevention of CMV disease in this population. This review summarizes important phase 3 trial design considerations for industry and provides rationale for some of the recommendations included in the guidance.<\/jats:p>","DOI":"10.1093\/infdis\/jiz389","type":"journal-article","created":{"date-parts":[[2019,7,26]],"date-time":"2019-07-26T15:09:09Z","timestamp":1564153749000},"page":"S109-S112","source":"Crossref","is-referenced-by-count":14,"title":["The Development of Therapeutics for the Treatment and Prevention of CMV Disease in the Transplant Population: A Regulatory Perspective"],"prefix":"10.1093","volume":"221","author":[{"given":"Aimee C","family":"Hodowanec","sequence":"first","affiliation":[{"name":"Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Infectious Diseases, Division of Antiviral, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Pikis","sequence":"first","affiliation":[{"name":"Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Infectious Diseases, Division of Antiviral, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary E","family":"Singer","sequence":"first","affiliation":[{"name":"Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Infectious Diseases, Division of Antiviral, Silver Spring, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,3,5]]},"reference":[{"key":"2020030507495817800_CIT0001","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1086\/338624","article-title":"High risk of death due to bacterial and fungal infection among cytomegalovirus (CMV)-seronegative recipients of stem cell transplants from seropositive donors: evidence for indirect effects of primary CMV infection","volume":"185","author":"Nichols","year":"2002","journal-title":"J 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Impact of the first international standard for cytomegalovirus DNA on the harmonization of results reported on plasma samples","volume":"63","author":"Preiksaitis","year":"2016","journal-title":"Clin Infect Dis"},{"key":"2020030507495817800_CIT0022","author":"Food and Drug Administration","year":"2017"}],"container-title":["The Journal of Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/jid\/article-pdf\/221\/Supplement_1\/S109\/32791266\/jiz389.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/jid\/article-pdf\/221\/Supplement_1\/S109\/32791266\/jiz389.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,3,5]],"date-time":"2020-03-05T07:50:07Z","timestamp":1583394607000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jid\/article\/221\/Supplement_1\/S109\/5781890"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,5]]},"references-count":22,"journal-issue":{"issue":"Supplement_1","published-online":{"date-parts":[[2020,3,5]]},"published-print":{"date-parts":[[2020,3,5]]}},"URL":"https:\/\/doi.org\/10.1093\/infdis\/jiz389","relation":{},"ISSN":["0022-1899","1537-6613"],"issn-type":[{"value":"0022-1899","type":"print"},{"value":"1537-6613","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2020,3,15]]},"published":{"date-parts":[[2020,3,5]]}}}