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We included the European Public Assessment Reports, Summaries of Product Characteristics, and published randomized controlled trials (RCTs) on anti\u2010cancer drugs approved by EMA from 2010 to 2019, and excluded drugs not indicated for targeting solid or hematological tumors and non\u2010innovative treatments. We synthesized frequencies of approvals differentiating between unblinded and blinded RCTs with and without overall survival (OS) as a predefined primary outcome measure. We assessed the frequency of post\u2010approval RCTs for indications without at least one RCT at the time of approval. Of 199 approvals, 159 (80%) were supported by at least one RCT, 63 (32%) by at least one RCT having OS as the primary or co\u2010primary endpoint, 74 (37%) by at least one blinded RCT, and 30 (15%) by at least one blinded RCT having OS as the primary or co\u2010primary endpoint. Whereas 40 approvals (20%) were not supported by any RCT and, of those, 9 (22%) were followed by a post\u2010approval RCT. While the majority of approvals of cancer medicines approved by EMA was supported by at least one RCT, we noted substantial methodological heterogeneity of the studies.<\/jats:p><jats:p><jats:bold>Clinical trial registration<\/jats:bold>: PROSPERO registration number CRD42020206669.<\/jats:p>","DOI":"10.1002\/prp2.816","type":"journal-article","created":{"date-parts":[[2021,7,7]],"date-time":"2021-07-07T18:58:46Z","timestamp":1625684326000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Strength of clinical evidence leading to approval of novel cancer medicines in Europe: A systematic review and data synthesis"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1896-1179","authenticated-orcid":false,"given":"Alberto","family":"Farina","sequence":"first","affiliation":[{"name":"Division of Healthcare Sciences Center for Clinical Research and Management Education Dresden International University Dresden Germany"},{"name":"Medical Affairs Department Celltrion Healthcare Italy srl Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2682-5583","authenticated-orcid":false,"given":"Federico","family":"Moro","sequence":"additional","affiliation":[{"name":"Laboratory of Acute Brain Injury and Therapeutic Strategies, Department of Neuroscience Istituto di Ricerche Farmacologiche Mario Negri IRCCS Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frederick","family":"Fasslrinner","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I University Hospital Carl Gustav Carus Technische Universit\u00e4t Dresden Dresden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annahita","family":"Sedghi","sequence":"additional","affiliation":[{"name":"Department of Neurology University Hospital Carl Gustav Carus Technische Universit\u00e4t Dresden Dresden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miluska","family":"Bromley","sequence":"additional","affiliation":[{"name":"Division of Healthcare Sciences Center for Clinical Research and Management Education Dresden International University Dresden Germany"},{"name":"Universidad Cientifica del Sur Lima Peru"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timo","family":"Siepmann","sequence":"additional","affiliation":[{"name":"Division of Healthcare Sciences Center for Clinical Research and Management Education Dresden International University Dresden Germany"},{"name":"Department of Neurology University Hospital Carl Gustav Carus Technische Universit\u00e4t Dresden Dresden Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,7,7]]},"reference":[{"key":"e_1_2_14_2_1","unstructured":"World Health Organization.Fact sheet cancer.https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/cancer. 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