Articles published in Clinical Research focusThere are many valuable research tools all ICR members can access through our website, and this piece is intended to help you use them more effectively. Helena walks through an example of reporting on all new drugs undergoing development in type II diabetes, using information tools available free to members through the ICR website.http://www.icr-global.org/crfocus/2008/19-7/information-corner-intelligence-data/Fri, 04 Jul 2008 17:37:51 GMTFri, 04 Jul 2008 17:30:25 GMTFri, 04 Jul 2008 17:37:51 GMTrestricted2425Near the start of Andrew’s presentation, he stated that studies conclude with mantra “more research is needed” so frequently it is commonly used as a humorous catch-phrase. While this is good news for those of us in the business of delivering this research, Andrew explored the current state of evidence-based medicine (EBM), suggesting that the ‘ideal’ of systematic reviews of multiple randomised controlled trials (RCTs) had been allowed to become the enemy of the ‘good’, discussed the issues and challenges http://www.icr-global.org/crfocus/2008/19-7/conference-evidence-based-medicine/Fri, 04 Jul 2008 17:25:06 GMTFri, 04 Jul 2008 17:21:36 GMTFri, 04 Jul 2008 17:25:06 GMTrestricted2424Australia and New Zealand are two of the least populated industrialised countries in the world. They share a heritage but are increasingly circumspect and pragmatic in looking at world events in health regulation. These were the starting messages of Adrian Bootes’ interesting presentation, which demonstrated how different, yet similar, their clinical research environment is to that of the UK. Adrian gave a huge amount of detail in his presentation, only some of which can be summarised here.http://www.icr-global.org/crfocus/2008/19-7/conference-australia-new-zealand/Fri, 04 Jul 2008 17:19:31 GMTFri, 04 Jul 2008 17:14:29 GMTFri, 04 Jul 2008 17:19:31 GMTrestricted2423Dr Louise Wood is Head of Innovation and Industry R&D Relations in the Research and Development Directorate of the Department of Health for England. She talks to us about the recent developments in the UK clinical research environment, driving transformational change across a diverse set of organisations and bringing together the “two cultures” of industry and the NHS for successful collaboration.http://www.icr-global.org/crfocus/2008/19-7/interview-louise-wood/Fri, 04 Jul 2008 17:11:23 GMTFri, 04 Jul 2008 16:53:53 GMTFri, 04 Jul 2008 17:11:23 GMTrestricted2420With so many technological and regulatory changes in recent years, it is easy to overlook the importance of individual and team performance in timely delivery of clinical trials. Paul and Tania present a short survey of the perceptions of individual team members to assess the importance of non-technical aspects of performance in both successful and unsuccessful trials.http://www.icr-global.org/crfocus/2008/19-7/performance-morale/Fri, 04 Jul 2008 16:50:44 GMTFri, 04 Jul 2008 16:28:39 GMTFri, 04 Jul 2008 16:50:44 GMTrestricted2417February 27th 2008 saw the first joint symposium held by the European Medical Writers Association (EMWA) and the Institute of Clinical Research (ICR). Nearly 100 members of the two professional organisations gathered in London to discuss the ethics and best practice of publishing clinical trials. Nancy and Andrew were there…http://www.icr-global.org/crfocus/2008/19-7/publishing-clinical-trials/Fri, 04 Jul 2008 16:21:29 GMTFri, 04 Jul 2008 16:07:26 GMTFri, 04 Jul 2008 16:21:29 GMTrestricted2413Andrew is cautious of being too critical of the recent announcement of a deal on the voluntary scheme to replace the Pharmaceutical Pricing Regulation Scheme (PPRS). However, it is certainly not the value-based pricing system many had hoped for. He ponders whether it could be a stop-gap while a more sophisticated system is developed, or a simple price cut, squandering the opportunity to improve on the current ‘blunt instrument’.http://www.icr-global.org/crfocus/2008/19-7/pprs-or-value-based-pricing/Fri, 04 Jul 2008 16:05:26 GMTFri, 04 Jul 2008 15:57:03 GMTFri, 04 Jul 2008 16:05:26 GMTrestricted2411This month saw the graduation of the first group of ICR/Cranfield Health students on the Clinical Research MSc course. On June 6th, Susan Ollier was a guest at a packed graduation ceremony at Cranfield University in Bedfordshire, UK. Her congratulations (and ours) go to all our graduates and especially to prize-winners Bridget Juniper and Javier Moreno Farre.http://www.icr-global.org/crfocus/2008/19-7/graduation-time/Fri, 04 Jul 2008 15:54:02 GMTFri, 04 Jul 2008 15:47:34 GMTFri, 04 Jul 2008 15:54:02 GMTrestricted2409ICR was elected a licensed body of the Science Council in October 2007, making it the only organisation permitted to award Chartered Scientist (CSci) status to clinical research professionals. Half-way through the first year of this new way to recognise the expertise of members, the authors reflect on the benefits of CSci designation.http://www.icr-global.org/crfocus/2008/19-7/chartered-scientist-csci/Fri, 04 Jul 2008 15:44:54 GMTFri, 04 Jul 2008 15:29:31 GMTFri, 04 Jul 2008 15:44:54 GMTrestricted2405Communicating in Clinical Research & Networking Laid Barehttp://www.icr-global.org/crfocus/2008/19-6/networking-laid-bare/Thu, 03 Jul 2008 16:56:49 GMTThu, 03 Jul 2008 16:51:59 GMTThu, 03 Jul 2008 16:56:49 GMTrestricted2388Reputation of the Pharmaceutical Industry: The Role of Communications & People in Researchhttp://www.icr-global.org/crfocus/2008/19-6/reputation/Thu, 03 Jul 2008 16:49:45 GMTThu, 03 Jul 2008 16:43:44 GMTThu, 03 Jul 2008 16:49:45 GMTrestricted2387In our international news section this month, we report the decision of the US Food & Drug Administration (FDA) to amend its regulation 21CFR312 on the acceptance of foreign clinical studies not conducted under an investigational new drug (IND) application as support for an IND or application for marketing approval for a drug or biological product in the USA. This new rule marks a further distancing from the text of the Declaration of Helsinki.http://www.icr-global.org/crfocus/2008/19-6/fda-vs-helsinki/Thu, 03 Jul 2008 16:39:37 GMTThu, 03 Jul 2008 16:36:45 GMTThu, 03 Jul 2008 16:39:37 GMTrestricted2386Communication in Clinical Research: Challenges in a Complex Worldhttp://www.icr-global.org/crfocus/2008/19-6/keynote-address/Thu, 03 Jul 2008 16:34:31 GMTThu, 03 Jul 2008 13:41:57 GMTThu, 03 Jul 2008 16:34:31 GMTrestricted2371Forward Planning in the ICR Boardroomhttp://www.icr-global.org/crfocus/2008/19-6/forward-planning-in-the-icr-boardroom/Thu, 03 Jul 2008 16:30:55 GMTThu, 03 Jul 2008 16:25:09 GMTThu, 03 Jul 2008 16:30:55 GMTrestricted2384Communicating the Human Side of Science & Technologyhttp://www.icr-global.org/crfocus/2008/19-6/closing-address/Thu, 03 Jul 2008 16:23:14 GMTThu, 03 Jul 2008 16:20:11 GMTThu, 03 Jul 2008 16:23:14 GMTrestricted2383Can industry collaborate with the emerging UK Clinical Research Networks (UKCRN) to achieve high recruiting and excellent quality clinical research, making the UK a more valuable contributor to international studies? The authors present a case study where involving a network ‘turned around’ the UK arm of a global study, and suggest how this type of collaboration could be made even more effective in future.http://www.icr-global.org/crfocus/2008/19-5/collaboration-with-the-stroke-research-network/Thu, 03 Jul 2008 13:18:01 GMTThu, 03 Jul 2008 12:56:58 GMTThu, 03 Jul 2008 13:18:01 GMTrestricted2364The 20th DIA EuroMeeting had a broad scope, discussing strategic issues in clinical research alongside statistical, regulatory and other aspects of the wider drug development process. In contrast with the ICR conference, the DIA meeting took less of a view of practical matters related to individual study sites, making the meeting an interesting complement to our own meeting. Andrew Smith presents some of the conference sessions…http://www.icr-global.org/crfocus/2008/19-5/dia-euromeeting-highlights/Thu, 03 Jul 2008 12:53:01 GMTThu, 03 Jul 2008 12:46:38 GMTThu, 03 Jul 2008 12:53:01 GMTrestricted2362The UK’s National Institute for Health and Clinical Excellence (NICE) is a child of New Labour and was born in April 1999. Bruised from a few falls (including legal challenges!), it is now growing up into a “strapping young lad”. It has particularly proud parents and NICE’s growth pains continue to be watched assiduously by many outside the UK. This was particularly the case over much of 2007, when the House of Commons Health Select Committee (HSC) held its second inquiry into NICE. Here we examine the resuhttp://www.icr-global.org/crfocus/2008/19-5/nice-has-grown-up/Thu, 03 Jul 2008 12:44:01 GMTThu, 03 Jul 2008 12:30:52 GMTThu, 03 Jul 2008 12:44:01 GMTrestricted2360A recent review has found that a growing number of oncology studies have been stopped early for benefit, with the data being used to support marketing applications. For a successful treatment, this widens the group of patients who could benefit while reducing total study costs and accelerating the drug to market. However, this also increases demands on the statistical robustness of the study. Andrew Smith surveys this ethical, scientific and commercial minefield.http://www.icr-global.org/crfocus/2008/19-5/dont-stop/Tue, 06 May 2008 09:00:00 GMTThu, 24 Apr 2008 15:44:18 GMTThu, 03 Jul 2008 12:43:31 GMTrestricted1892