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International Clinical Trials
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Given that much of the world is
facing the challenge of a third wave
(France, Germany, Japan, Korea,
Spain) or even still the first wave
(India, the US), it requires a degree
of ‘blue-sky thinking’ to contemplate
what a post-COVID-19 world will
look like – even though the first
vaccines are now being widely
administered to populations outside
the clinical trial setting in several
countries (including the UK and the
US). As with any prediction, unless
one is either lucky, a gifted visionary,
or, indeed, both, the further into the
future one goes, the less accurate
the forecast is likely to be. With that
caveat, I would like to suggest a few
themes that I think it is reasonable
to expect will feature in this new,
post-pandemic landscape – which
I will place, a tad optimistically
perhaps, in the first half of 2022.
In order to reach this position, there
will have to be an effective vaccine
– or, rather more likely, several
effective vaccines – which will have
been administered to very many
people in most of the world. This is
likely to have a significant impact
on pharmacovigilance globally, both
in terms of the number of reports,
which will foreseeably arise from
the vaccine’s administration itself,
and because most, if not all, other
reports of (suspected) adverse drug
reactions will necessarily involve the
COVID-19 vaccine(s) as concomitant
medication(s).
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Dr Thomas Leigh is the Head of the medical
group within patient safety solutions atCovance. He leads a global team of over
180 physicians and specialist nurses in key
locations across the US, Europe, and Asia,
that provide expert medical input as part of
a comprehensive safety offering to sponsors
around the world through their products’
entire lifecycles, encompassing clinical trial
and post-marketing/post-approval safety, for
drugs, devices, and combination products.
Before joining Covance in 2012 as a Safety
Physician, Tom worked for the MHRA, the UK
Regulatory Authority, as a Medical Assessor
and Unit Manager within the Vigilance & Risk
Management of Medicines Division (VRMM).
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News and Press Releases |
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Evonetix Appoints Colin McCracken as Chief Executive Officer
Cambridge, UK, 13 June 2022: EVONETIX LTD (‘Evonetix’), the
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Executive Officer with immediate effect. Colin’s appointment will
support the next phase of the Company’s development and the
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White Papers |
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The Promise and Challenge of Adaptive Design in Oncology Trials
Medpace
Clinical oncology trials are more complex and time consuming than those
in any other therapeutic area and failure rates are frustratingly high.
Given the urgent need for new oncologic therapies, sponsors are eager to
find more effective ways to conduct clinical research.
Incorporating adaptive design methodologies into clinical trials can
reduce costs and enhance efficiency while maintaining trial integrity.
They can also reduce the number of patients on placebo and
sub-therapeutic doses. In light of this promise, regulatory bodies have
created guidelines supportive of adaptive design.
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