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Cell‐Free Artificial Liver Support: Design of Appropriate Clinical Studies
Author(s) -
Bernal William,
Wendon Julia
Publication year - 2006
Publication title -
therapeutic apheresis and dialysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.415
H-Index - 53
eISSN - 1744-9987
pISSN - 1744-9979
DOI - 10.1111/j.1744-9987.2006.00360.x
Subject(s) - medicine , clinical trial , clinical study design , intensive care medicine , research design , randomized controlled trial , medline , risk analysis (engineering) , medical physics , pathology , social science , sociology , political science , law
The clinical use of cell‐free liver support devices is dependent upon proof of safety and efficacy in clinical trials. The current published data to support their use is limited in both quantity and quality. In most studies, the methodology is such that the effects of these devices are difficult to establish with certainty. Bias might be introduced by the use of uncontrolled studies, and in randomized controlled trials limited size, poorly matched control groups or medical therapy or the use of clinically inappropriate endpoints might be important. Guidelines are now available to provide a framework for the design and execution of such trials, specifically to minimize the systematic errors that are frequently present and that might result in biased estimates of treatment effects. In the present review, the limitations of current studies are discussed and suggestions made as to the design and conduct of future clinical trials.