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International Clinical Trials

Comment from the Editor

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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