Biomedical Engineering Reference
In-Depth Information
wake of the thalidomide disaster, FDA legislation was amended
again in 1962 so that efficacy came to be included as a mandatory
component of the drug approval process (Borchers et al., 2007). The
randomized controlled clinical trial was subsequently established as
the gold standard of both efficacy and safety required by the FDA
over the next decade (Borchers et al., 2007).
The use of clinical trials has had a long and complex history in
twentieth-century medicine. The scientific and ethical provenance of
clinical trials has been challenged on a range of issues. Some of these
include:
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the randomization and structure of clinical trials (Avins, 1998);
the value of doing clinical trial research (Wells, 1999);
the ethics of using placebos (Carpenter et al., 2003);
the nature of informed consent (Corrigan, 2003);
access to experimental drugs (Epstein, 1995);
concern for the protection of vulnerable populations (Fisher, 2009);
the influence of drug companies on clinical trial research
(Healy, 2004);
the professionalization of clinical trial subjects (Abadie, 2010);
compensation for participants who experience adverse reactions
(Barton et al., 1995); and
the globalization of clinical trials research (Petryna, 2006).
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While the social, political and cultural contexts of the clinical trial
often raise more questions than they answer, for the FDA approval
process it is the main route through which safety and efficacy for a
new product can be established.
Some of the safety concerns associated with hESC research are the
potential for cancer-formation produced by hESC transplants, issues
about the possible uncontrollable differentiation of hESCs once
implanted, whether the animal studies done so far provide enough
reliable evidence of the potential impact on human subjects, how the
resultant cells will be identified
in vivo
and what forms of monitoring
are most appropriate for subjects participating in research (Baker,
2008). In particular, there are some indications that hESCs are more
prone to tumor formation than adult stem cells (Hentze et al., 2007).
