Biomedical Engineering Reference
In-Depth Information
about the future safety, efficacy and quality of the therapy, neither will they
enable researchers fully to appreciate the long-term change in quality of
life. extrapolations of data gathered during trials will allow some long-term
prognoses, but these will always contain a degree of uncertainty. The actual
long-term effects can only be judged during the follow-up process. as has
been pointed out by the national institute for clinical excellence (nice)
for one of the few well researched clinical applications of tissue engineered
products - autologous cartilage implants - the use of these products has to
be considered as part of an ongoing clinical trial, because of uncertainties
about the long-term effectiveness and the potential adverse effects of the
procedure. a similar argument could be applicable to BTePs.
one could consider the trial as an integrated part of the chain of production,
testing and application of BTePs. This approach allows us to integrate various
findings. Information gathered from clinical trials and from the post-clinical
trial phase can lead to an adjustment of the culture conditions of the BTeP
in order to provide a better adapted BTEP for the specific application. It
might therefore be useful to think of BTePs as 'therapies under control' or
of 'technology under investigation' (Wasiak
et al.
, 2006). This also implies
that governance of post-trial events needs to be established (Trommelmans
et al
., 2007b).
16.6 Access to therapy
16.6.1 Introduction
if BTePs eventually become available for therapy, their actual application
will not solely depend on the clinical evidence but also on other factors,
including the evaluation of the economic viability of these products (mcateer
et al
., 2007) and their reception by end users, both surgeons and patients.
These products will unquestionably be very expensive, which implies that
the decision to apply them will also have repercussions for health care
organisations (Bock
et al
., 2003). Besides the economic aspects, the ethical
(and political) issue of the just distribution of health care is at stake. if we
want to uphold the principle that those most in need of a specific treatment
should be able to get it, whatever its cost and regardless of the patient's
financial resources, we will have to apply some reimbursement strategy.
But the presence of living, donated cells in BTePs again adds new ethical
issues on top of the already difficult exercise of determining who will have
access to these BTePs.
16.6.2 Biological perspectives
The access of the individual patient to a compatible BTEP will depend first
and foremost on the availability of compatible cells for their construction
