Celeste Cagnazzo, Marco Basiricò, Federica Palermo, Franca Fagioli
{"title":"Observational studies - The Cinderella of the Italian research system.","authors":"Celeste Cagnazzo, Marco Basiricò, Federica Palermo, Franca Fagioli","doi":"10.1177/03008916231166469","DOIUrl":null,"url":null,"abstract":"<p><p>Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance of this type of studies, Italian researchers have had to face many obstacles over the years, mainly due to ambiguous definitions and to a complex but at the same time incomplete legislation. The regulatory adjustments to the European Regulation 536/2014 have further complicated the operating and operational framework, making observational research a real \"Cinderella\" of the Italian system.</p>","PeriodicalId":23349,"journal":{"name":"Tumori","volume":" ","pages":"524-528"},"PeriodicalIF":3.1000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Tumori","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/03008916231166469","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/4/8 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 1
Abstract
Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance of this type of studies, Italian researchers have had to face many obstacles over the years, mainly due to ambiguous definitions and to a complex but at the same time incomplete legislation. The regulatory adjustments to the European Regulation 536/2014 have further complicated the operating and operational framework, making observational research a real "Cinderella" of the Italian system.
期刊介绍：
Tumori Journal covers all aspects of cancer science and clinical practice with a strong focus on prevention, translational medicine and clinically relevant reports. We invite the publication of randomized trials and reports on large, consecutive patient series that investigate the real impact of new techniques, drugs and devices inday-to-day clinical practice.
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