title: Methodological assessment of HCC literature.
abstract: Despite the fact that the hepatocellular carcinoma (HCC) represents a major health problem, very few interventions are available for this disease, and only sorafenib is approved for the treatment of advanced disease. Of note, only very few interventions have been thoroughly evaluated over time for HCC patients compared with several hundreds in other, equally highly lethal, tumours. Additionally, clinical trials in HCC have often been questioned for poor design and methodological issues. As a consequence, a gap between what is measured in clinical trials and what clinicians have to face in daily practice often occurs. As a result of this scenario, even the most recent guidelines for treatment of HCC patients use low strength evidence to make recommendations. In this review, we will discuss some of the potential methodological issues hindering a rational development of new treatments for HCC patients.
authors.affiliation: Clinical Trials Unit, National Cancer Institute of Naples, Naples, Italy. gennaro.daniele@usc-intnapoli.net
authors.forename: G
authors.initials: G
authors.lastname: Daniele
authors.forename: N
authors.initials: N
authors.lastname: Costa
authors.forename: V
authors.initials: V
authors.lastname: Lorusso
authors.forename: J
authors.initials: J
authors.lastname: Costa-Maia
authors.forename: I
authors.initials: I
authors.lastname: Pache
authors.forename: M
authors.initials: M
authors.lastname: Pirisi
mesh_terms: D015706:Bibliometrics; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D023381:Endpoint Determination; D019317:Evidence-Based Medicine; D006801:Humans; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D011237:Predictive Value of Tests; D012107:Research Design; D012307:Risk Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: hepatocellular carcinoma; methodology; observational studies; randomized, clinical trials; sorafenib