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International Clinical Trials

Strategic Interaction

Approaching ‘eClinical’ as a new philosophy for clinical trial management, Ian O’Shaughnessy at ICON Clinical Research believes that with the correct strategy the transition to eClinical trials can be managed effectively

The adoption of internet technology and electronic media to support clinical research and the management of clinical trials has been one of the most significant changes in the pharmaceutical industry over the last five years. A new way of working, commonly termed ‘eClinical’, has emerged based on technologies that enable electronic data capture (EDC). While the pace of this change is accelerating, the significant challenge of managing the transition to eClinical trials still remains at the operational level within organisations.

MANAGING INDUSTRY ATTITUDES AND PERCEPTIONS

Across the clinical research industry, misconceptions – primarily among those who have not been directly impacted by its use – have affected the early implementation of eClinical, and, in order to make the transition a successful one, significant education is required to address such perceptions. The first misconception to address is the belief that eClinical as a business approach should be driven purely by technology specialists and data managers. The second is that eClinical and EDC are merely technological solutions rather than an entirely new way of conducting clinical trials that will impact on all those involved. However, implemented in its entirety, eClinical marks a significant, if not complete, change in the approach to conducting clinical research trials.


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Ian O’Shaughnessy is a Project Manager in Data Management at ICON Clinical Research in Ireland. He has worked in the industry for 10 years and has been with ICON since 2002, working in both data management and database programming. He currently leads a team of data managers working on eClinical Trials. Ian was educated at Trinity College Dublin where he was awarded a Bachelor of Arts with Honours in Genetics in 1996. In 1999, he obtained a Postgraduate Diploma in Business Studies and Information Technology.
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

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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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