Articles published in Clinical Research focus http://www.icr-global.org/crfocus_articles.rss On March 7th, John Dalli, Member of the European Commission for Health and Consumer Policy gave the following speech at an event in Brussels. In the speech, he makes several strong points about the future of the Clinical Trials Directive and how many of the criticisms that have been levelled at it over the past decade will be addressed in a Regulation, to be put before the European Parliament in the coming months. We report the full text of this speech with permission of Commissioner Dalli's office. http://www.icr-global.org/crfocus/2012/23-1/future-of-the-eu-clinical-trials-directive/ 10674 Wed, 14 Mar 2012 12:26:41 GMT 20120314122641 Wed, 14 Mar 2012 12:10:48 GMT 20120314121048 Wed, 14 Mar 2012 12:26:41 GMT 2012031412122641 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Few would disagree that study globalisation, proportional risk adaptation, bureaucracy busting, and more efficient processes are necessary components for the pharmaceutical industry to meet society's demands for faster, cheaper medicines while also satisfying their investors' demands for return on investment. However, some suggest our collective focus on getting drugs to market quicker may inadvertently compromise patient safety. The authors explore whether global study data is truly transferable to local p http://www.icr-global.org/crfocus/2012/23-1/cheaper-faster-safer/ 10669 Thu, 19 Apr 2012 11:53:11 GMT 20120419115311 Tue, 13 Mar 2012 12:29:54 GMT 20120313122954 Thu, 19 Apr 2012 11:53:11 GMT 2012041911115311 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Last summer, I had the honour to join the Board of Directors of The Institute of Clinical Research. In this column, I'd like to introduce myself and tell you a little of my vision for our profession and ICR's role within it. http://www.icr-global.org/crfocus/2012/23-1/introduction-personal-vision/ 10649 Fri, 09 Mar 2012 12:15:47 GMT 20120309121547 Thu, 08 Mar 2012 11:09:19 GMT 20120308110919 Fri, 09 Mar 2012 12:15:47 GMT 2012030912121547 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Even without realising it, reading CRfocus contributes to your Continuing Professional Development (CPD). This month's quiz tests your understanding and recollection of topics explored in the October issue of CRfocus. In a change to previous quizzes, we have now moved to a process of self-marking when the answers are published in the following issue of CRfocus. http://www.icr-global.org/crfocus/2012/23-1/cpd-quiz/ 10639 Tue, 06 Mar 2012 12:10:28 GMT 20120306121028 Tue, 06 Mar 2012 12:04:29 GMT 20120306120429 Tue, 06 Mar 2012 12:10:28 GMT 2012030612121028 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Jane Tucker is an independent consultant and trainer, most recently specialising in risk assessment and management. She presents ICR's training courses on Risk Management Principles, Study Level Risk Management and Risk-Based Monitoring. In this interview, she discusses How to decide what level of monitoring to do at which site, what industry has to gain from risk-based monitoring and what is changing to enable it to become part of the mainstream of clinical development. http://www.icr-global.org/crfocus/2012/23-1/understanding-risk-based-monitoring/ 10638 Tue, 06 Mar 2012 12:01:54 GMT 20120306120154 Tue, 06 Mar 2012 11:53:08 GMT 20120306115308 Tue, 06 Mar 2012 12:01:54 GMT 2012030612120154 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Informed consent for clinical research is both very simple and very complex. The principle is clear that a competent adult must be given adequate information and give their consent before taking part in a clinical trial. But how much information is adequate, how should written information be balanced with explanation and discussion, and how can the requirement for standardised documentation accommodate individual participants' differing questions and concerns? Perhaps more importantly, is the increasing l http://www.icr-global.org/crfocus/2012/23-1/consent-information-language/ 10637 Tue, 06 Mar 2012 11:49:23 GMT 20120306114923 Tue, 06 Mar 2012 11:34:47 GMT 20120306113447 Tue, 06 Mar 2012 11:49:23 GMT 2012030611114923 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Within the pharmaceutical industry, we are slowly but surely coming into line with the streamlining and efficiencies we once simply observed in other industries. Personal development is all about taking yourself outside of your comfort zone. Doing this leads us to feel a greater sense of achievement in the day-to-day activities we describe as work. Sandy Prasad explains why taking personal control of your own development is essential, and offers some tips to start you on your journey. http://www.icr-global.org/crfocus/2012/23-1/your-future-in-your-hands/ 10636 Tue, 06 Mar 2012 11:31:08 GMT 20120306113108 Tue, 06 Mar 2012 11:25:39 GMT 20120306112539 Tue, 06 Mar 2012 11:31:08 GMT 2012030611113108 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus Much has been made of the performance gap between Western Europe and other regions in terms of clinical trial approvals, start-up and patient recruitment. While other parts of the world have demonstrated explosive growth in recent years, the EU has at least started to redress the balance, with benchmark data on study approval, site initiation and patient recruitment to target all now improving compared with a few years ago. However, a new study published by the Center for the Study of Drug Development at Tu http://www.icr-global.org/crfocus/2012/23-1/the-other-performance-gap/ 10635 Tue, 06 Mar 2012 11:23:05 GMT 20120306112305 Tue, 06 Mar 2012 11:20:23 GMT 20120306112023 Tue, 06 Mar 2012 11:23:05 GMT 2012030611112305 http://www.icr-global.org/crfocus/ Andrew Smith Page CRfocus_page CRfocus