Design and Endpoints of Clinical Trials in Hepatocellular Carcinoma
Harvard University · National Institutes of Health · +8 more institutions
Abstract
The design of clinical trials in hepatocellular carcinoma (HCC) is complex because many patients have concurrent liver disease, which can confound the assessment of clinical benefit. There is an urgent need for high-quality trials in this disease. An expert panel was convened by the American Association for the Study of Liver Diseases to develop guidelines that provide a common framework for designing trials to facilitate comparability of results. According to these guidelines, randomized phase 2 trials with a time-to-event primary endpoint, such as time to progression, are pivotal in clinical research on HCC. Survival remains the main endpoint to measure effectiveness in phase 3 studies, whereas time to…
Citation impact
- FWCI
- 63.23
- Percentile
- 100%
- References
- 70
Authors
11- JMJosep M. LlovetCorresponding
Harvard University, National Institutes of Health, Massachusetts General Hospital, Icahn School of Medicine at Mount Sinai, Mayo Clinic in Arizona, University of Pisa, University of Pittsburgh, Saint Louis University, University of Toronto, Office of Disease Prevention
- AMAdrian M. Di Bisceglie
University of Pisa, Saint Louis University, Massachusetts General Hospital, Harvard University, National Institutes of Health, University of Pittsburgh, Icahn School of Medicine at Mount Sinai, Office of Disease Prevention, Mayo Clinic in Arizona, University of Toronto
- JBJordi Bruix
University of Toronto, University of Pittsburgh, National Institutes of Health, Massachusetts General Hospital, University of Pisa, Saint Louis University, Office of Disease Prevention, Icahn School of Medicine at Mount Sinai, Mayo Clinic in Arizona, Harvard University
- BSBarnett S. Kramer
Massachusetts General Hospital, Office of Disease Prevention, University of Pittsburgh, Icahn School of Medicine at Mount Sinai, University of Toronto, Mayo Clinic in Arizona, National Institutes of Health, Harvard University, University of Pisa, Saint Louis University
- RLRiccardo Lencioni
Icahn School of Medicine at Mount Sinai, National Institutes of Health, University of Pisa, Massachusetts General Hospital, Office of Disease Prevention, Saint Louis University, University of Toronto, Harvard University, University of Pittsburgh, Mayo Clinic in Arizona
Topics & keywords
- Medicine
- Clinical endpoint
- Clinical trial
- Surrogate endpoint
- Clinical study design
- Sorafenib
- Oncology
- Internal medicine