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International Clinical Trials
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It is always interesting to read articles looking at two different sides
of the same coin. In this issue, we have a paper from Jens Puhle at
8MAN which discusses how intellectual property is the lifeblood of the
pharmaceutical industry, and how the ability to keep data relating to
intellectual property hidden from rival organisations is essential in
this highly competitive world. Puhle warns that data theft caused by
hackers may be only one of the threats that companies should be aware
of, and that they should actually be looking closer to home. He reports
on GlaxoSmithKline and other businesses that have recently had employees
indicted for fraud, and discusses how strict access control and
monitoring of staff may be necessary to prevent the theft of research
data that could make or break a business.
The other side of this
coin is examined by Graham Donaldson at TRAC Services, with respect to
clinical trial data which the EMA is attempting to make much more
transparent – especially in regards to the new EU Clinical Trial
Regulation. He notes that releasing information about the development
and registration of medicines in the public domain is required to make
sure the regulatory process is trusted, and decision-makers are
well-informed. Thus, a balanced approach is necessary when discussing
disclosure of European medical research. The article also explores
various attitudes from regulatory authorities towards data transparency,
and highlights the EMA’s approach to moving forward.
A couple
of papers in this edition look at different aspects of oncology and
clinical trials to develop drugs in that indication. Dr Don Gabriel of
United BioSource Corporation considers the implications of
pharmacogenetics – the study of individuals’ genetic variations on
clinical studies – and explains how these can relate to oncology in
particular. We are used to hearing that personalised medicine – now
perhaps more properly called precision medicine – is an ever-growing
area of interest, and essential to each individual’s genomic make-up.
The article discusses how pharmacogenetics is redefining the approach to
drug development, especially in oncology with relation to diagnosis and
classification, treatment regimes and posttreatment monitoring of
patients.
Dr Martin Lachs at ICON investigates a more practical
aspect of running clinical trials in cancer patients. He observes that
few patients in both the US and the UK have access to clinical trials
or, perhaps more accurately, avail themselves of the opportunity to take
part in them. He believes that the relationship between investigators
and service providers is crucial in running successful trials, and looks
at many of the aspects of the process of running the study – including
scientific, structural, financial and cultural aspects – before
examining the role CROs can play in a trial.
Finally, I would
like to highlight the paper by Dr Graham Wylie at MRN, who discusses the
fact that paediatric trials have become considerably more common as a
result of governmental and regulatory pressures. He notes that these
trials present a huge challenge from both scientific and ethical points
of view. A specific aspect of the trial methodology is the increasing
use of home healthcare services, and he examines how these may be
increasingly applied in running paediatric trials in the future, as
patient experience becomes an ever-more important factor.
I hope you enjoy the rest of the magazine and will consider contributing an article yourself!
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News and Press Releases |
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