home > ict > spring 2016 > editorial comment
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!

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.


Print this page
Send to a friend
Privacy statement
News and Press Releases

CPhI China opens with analysis pointing to a surge in growth in 2019

Shanghai, 23rd May 2019: New analysis released ahead of CPhI & P-MEC China (#CPhIChina and #PMECChina) – co-organized by Informa Markets, CCCMHPIE, and Shanghai Sinoexpo Informa Markets – forecasts that China will continue to grow strongly through 2019/20, thanks in part to a marked improvement in its global reputation.
More info >>

White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.


Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >>

Industry Events

Multimodal 2019

18-20 June 2019, NEC, Birmingham, UK

Now in its twelfth year, Multimodal is the UK and Ireland’s premier freight transport, logistics and supply chain management event.  Shippers and cargo owners attend to improve their businesses; by finding ways of moving their products more efficiently and by meeting new suppliers. 
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement