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International Clinical Trials

Editorial Comment

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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