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International Clinical Trials
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The Ebola crisis in West Africa – the worst outbreak of this lethal
virus in history – continues to unfold, endangering the lives of local
populations and international health workers. Clinical trials are
currently ongoing for a number of different vaccines, which could make a
dramatic difference, but no breakthrough can be expected for many
months.
It is therefore appropriate for ICT to consider
vaccine trials in this edition, with Robert Lins of SGS Life Science
Services examining the use of adjuvants. These agents boost the
immunogenicity of modern vaccines that are often derived from
recombinant or synthetic antigens.
The choice of adjuvant can be
critical to a vaccine's success; however, this adds to the complexity
of the development process and leads to a host of challenges for
scientists and clinicians at all stages of the pipeline. Unfortunately,
as Lins points out, adjuvants can also add to the safety issues of
vaccines used in early human trials. But, as in the case of Ebola and
possibly other diseases that have only as yet been partially studied,
openness of discussion with experts in the field will be absolutely
essential.
Vaccines are also among the topics covered by Ann
Neuer of Medical deScriptions in her analysis of how electronic data
records – or eSource – is reinventing data collection. The elimination
of paper documentation allows for more accurate and faster data capture,
and this may be particularly appropriate in geographical areas lacking
in infrastructure and connectivity, such as the tropical regions where
vaccine trials often take place.
The author exemplifies this in a
case study of a vaccine for tuberculosis in Africa where there was a
significant lowering of barriers to conducting clinical research in
isolated locations where the disease prevails. eSource can equally be
applied in neurology and dermatology studies, as Neuer highlights.
Indeed, this technology – encouraged by regulatory agencies – holds much
promise to speed the development of vitally needed therapies.
Elsewhere,
Claire Sears and Elisa Cascade from DrugDev talk about a different, but
nonetheless crucial, type of data – that which applies to investigative
sites. This data is key in the early step of selecting and evaluating
sites. The difficulty for clinical trial organisations is one of
integrating data from multiple, disparate sources. This may require
sharing and collaborating on investigatorfacing activities by companies
carrying out trials.
The evaluation of investigative sites is
just one aspect of a feasibility study, and Graham Wylie at the Medical
Research Network wonders if we have got it all wrong when it comes to
this kind of assessment. He argues that a major rethink is needed to
address resources in the running of trials. This whole issue is
complicated by the increased accessibility of digital data which can now
enable companies to locate and recruit patients directly via social
media, rather than through sites.
Sharing data about
investigative sites is one aspect of the TransCelerate BioPharma
initiative launched in 2012. Other aspects of this non-profit effort are
explored by David Allen from ADAllen Pharma in his take on comparator
drug supply. He warns that the mechanisms for acquiring comparator drugs
are currently inefficient, unpredictable, and can lead to substantial
delays – both in a clinical study and the eventual availability of the
drug to patients in need.
As with many of the preceding years,
2014 was a challenging one for CROs and sponsors. Perhaps, with closer
collaboration between companies themselves, the increasing maturity of
strategic alliances, and the greater involvement of regulatory agencies,
this new year may be a little easier for everyone in our industry.
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