观察研究
重症监护医学
随机对照试验
混淆
临床试验
不利影响
医学
肝细胞癌
癌症
梅德林
金标准(测试)
临床研究设计
精密医学
疾病
内科学
病理
政治学
法学
作者
Giuseppe Cabibbo,Ciro Celsa,Lorenza Rimassa,Ferrán Torres,Jordi Rimola,Roman Kloeckner,Jordi Bruix,Calogero Cammà,María Reig
标识
DOI:10.1016/j.jhep.2024.01.018
摘要
Randomized controlled trials (RCTs) represent the gold standard for evidence generation across all areas of medicine and especially in the oncology field, as they allow unbiased estimates of treatment effect without confounders. Observational studies have many problems that could reduce their internal and external validity. However, large prospective (well-conducted) observational real-world studies (RWS) can detect the occurrence of rare adverse events or monitoring for long-term adverse events. Impact of Real Word Data (RWD), which refers to data generated from routine, standard care of patients, and real-world ‘evidence’ (RWE), which is the evidence generated from RWD represent an open challenge.Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumor burden but also to the severity of underlying chronic liver disease. Moreover, advances in systemic therapies for HCC have increased the complexity of HCC patient management.Aim of this review article is to provide an overview of the benefits and limitations of different study designs, particularly focusing on RCTs and observational studies, to address important and not fully resolved questions in HCC research.
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