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European Pharmaceutical Contractor

EDC: Quo Vadis?

To write about EDC in the year 2002 is a somewhat ambiguous enterprise. From a technical viewpoint, a proselyte of this still relatively new technique can be proud of the currently almost exploding number of publications on this topic, which makes him wonder what has been left to write about. On the other hand there are points which can't be stressed often enough, together with the need to take into account all the novelties in this fast-changing environment. From an economic and philosophical point of view, especially after the downturn of the so-called 'new economy' and the recent unpleasant revelations on 'creative accounting' in major companies, the need for positive information regarding the future of this industry is greater than ever. YES, Internet and information technology will revolutionise the clinical research industry, BUT they'll do it at different speeds and in different ways than may have been anticipated some two years ago.

EDC: the market

The market for software and services related to clinical trial processes is worth US$874 million, is growing at 17 per cent a year and will reach US$1.49 billion by 2004 (1). There is apparently a market of remarkable size, reflecting the worldwide interest in this form of clinical data management.

A multitude of different systems and solutions can be distinguished: proprietary systems, developed either by big (multinational) pharmaceutical corporations or contract research organisations (CROs) for their own purposes; 'off-the-shelf' solutions offered by software providers; tailor- made systems of medium-sized CROs, developed in conjunction with web programmers; adapted statistical software systems... a situation characteristic of a pioneering period. Each of these solutions has its distinguishing features.


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By Dr Thomas Bart, Managing Director of eCR e-Clinical Research GmbH

Dr Thomas Bart is Managing Director of eCR e-Clinical Research GmbH. He studied Communication Science and National Economy at the Technical University of Berlin and Medicine at the University of Tübingen, graduating in 1989. His clinical experience is primarily in cardiology, with a specialisation in ECG and ABPM (ambulatory blood pressure monitoring).

In 1991 he joined F. Hoffmann-La Roche, Switzerland, to work in different roles in pharmaceutical marketing and clinical research. From 2000 to 2001 he was Medical Director of Boomerang Pharmaceutical Communications, a French agency developing web-based communication programmes for pharmaceutical companies. In addition to his engagement at e-Clinical Research, Thomas is an independent consultant to the pharmaceutical industry.

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Dr Thomas Bart
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4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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