Articles published in Clinical Research focusFollowing a recent comparison survey conducted by CK Clinical, which researched the attitudes of jobseekers in the pharmaceutical industry in January compared to that of July 2009, it seems respondents generally feel the wider economy is on the mend. However, at grassroots level, employees in the pharmaceutical industry are starting to feel the bite of the recession. Catherine Gutsell interprets the results of the survey.http://www.icr-global.org/crfocus/2009/20-12/employee-confidence-survey/Tue, 22 Dec 2009 11:05:08 GMTMon, 21 Dec 2009 16:54:56 GMTTue, 22 Dec 2009 11:05:08 GMT6329The Clinical Trial Administrator Special Interest Group (CTA SIG) is proud to announce the launch of a CTA Manual, written for CTAs by CTAs, to serve as a centralised reference document for CTAs throughout the industry. This document contains essential background information, covering topics such as the structure of a typical clinical department, industry-related acronyms, some of the key roles and responsibilities of a CTA and a snapshot of relevant areas of clinical research and its processes.http://www.icr-global.org/crfocus/2009/20-12/cta-manual/Mon, 21 Dec 2009 16:39:19 GMTMon, 21 Dec 2009 16:35:27 GMTMon, 21 Dec 2009 16:39:18 GMT6328Questions submitted to the ICR GCP Forum are sometimes discussed by the Steering Group between meetings, and in the case of this query, relating to the informed consent and safety reporting issues raised by the partner of a clinical trial subject becoming pregnant, the team thought that it would be beneficial to share their thoughts with readers of CRfocus rather than wait until the next Forum meeting.http://www.icr-global.org/crfocus/2009/20-12/gcp-discussion/Mon, 21 Dec 2009 16:30:57 GMTMon, 21 Dec 2009 16:27:02 GMTMon, 21 Dec 2009 16:30:57 GMT6326A clinical research freelancer’s life can be a bit solitary at times, so the annual ICR Freelance Forum provides a much-appreciated opportunity for freelancers to socialise and network with colleagues, and to learn from each other and from invited speakers. This year’s forum took place on November 3rd at the ICR headquarters in Bourne End. Topics reported by Danielle include records management, MHRA inspection of freelancers, surrogate biomarkers and the impact of clinical research networks.http://www.icr-global.org/crfocus/2009/20-12/freelance-forum/Mon, 21 Dec 2009 16:20:55 GMTMon, 21 Dec 2009 16:16:52 GMTMon, 21 Dec 2009 16:20:55 GMT6325We present our regular index of all articles published in CRfocus during 2009. Nearly 100 articles have covered a wide variety of topics throughout this year. Under difficult trading conditions, we have taken the opportunity to increase the proportion of editorial pages by around 10% so as a reader you are getting more concentrated value from your ICR membership. Don’t forget, one of the many benefits of ICR membership is that you also have full access to our online archive, containing almost every article http://www.icr-global.org/crfocus/2009/20-12/2009-article-index/Wed, 16 Dec 2009 15:18:14 GMTWed, 16 Dec 2009 12:50:43 GMTWed, 16 Dec 2009 15:18:13 GMT6303A regular feature of the end of the year in Clinical Research focus is our ‘crystal ball’ article, in which ‘movers and shakers’ and other key observers look into the future to tell us what they expect, or hope, to see changing over the coming years.http://www.icr-global.org/crfocus/2009/20-12/aspirations-expectations/Wed, 16 Dec 2009 12:39:14 GMTWed, 16 Dec 2009 12:24:38 GMTWed, 16 Dec 2009 12:39:14 GMT6302David Gillen is Head of Medical for the Pfizer Primary Care Business Unit covering Europe, Canada, Australia and New Zealand. Until last year, he was UK Medical Director. He is a member of the Editorial Advisory Board of the British Medical Journal and also serves on sub-committees of the ABPI, NICE and UKCRC. We discuss health technology assessment, the role of medics in the pharmaceutical industry and how the UK should look to specialise and become more entrepreneurial.http://www.icr-global.org/crfocus/2009/20-12/interview-david-gillen/Mon, 07 Dec 2009 16:59:36 GMTMon, 07 Dec 2009 16:52:53 GMTMon, 07 Dec 2009 16:59:35 GMT6263It’s been a tough year. As Janette Benaddi says in her column, most of us are slogging through to the end of 2009 battered and bruised by the economic turbulence, the accelerating strategic shift in where clinical research is being conducted and, more insidiously, the feeling of uncertainty that all of us are feeling as a result of these factors. Still, it is also important to recognise that there have been some positive developments in the sector, some of which will continue to have an impact long after thhttp://www.icr-global.org/crfocus/2009/20-12/highlights-of-2009/Mon, 07 Dec 2009 16:49:35 GMTMon, 07 Dec 2009 16:42:43 GMTMon, 07 Dec 2009 16:49:35 GMT6262As 2009 draws to a close, many of us will no doubt find ourselves looking back over the past 12 months and assessing how our lives and work have evolved. Some of us are perhaps a little confused, battered and bruised with the instability that has been around us both personally and at work. That said, for some of us it might have been the best year yet; I do hope that the latter is the case for many of you.http://www.icr-global.org/crfocus/2009/20-12/icr-highlights-of-2009/Mon, 07 Dec 2009 16:38:47 GMTMon, 07 Dec 2009 16:35:42 GMTMon, 07 Dec 2009 16:38:47 GMT6261How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharmaceutical industry and the patient? “Personalised medicine” is a current buzzword, but what does it actually mean? Some say it has the potential to affect the entire landscape of our healthcare system over the next ten to 20 years. Abel Ureta-Vidal explores http://www.icr-global.org/crfocus/2009/20-11/personalised-medicine/Wed, 25 Nov 2009 11:43:29 GMTTue, 24 Nov 2009 10:24:09 GMTWed, 25 Nov 2009 11:43:29 GMT6177The Institute of Clinical Research is pleased to announce that its 31st Annual Conference and Exhibition, with an overall theme of “Science, Society and Economics: Shaping the Future of Clinical Research”, will once again include a poster session. In this brief introduction to the 2010 competition, we present some highlights from the 2009 competition and invite you to submit an abstract for a poster at this year’s event. You can submit your poster abstract for consideration using the online form at www.icr-http://www.icr-global.org/crfocus/2009/20-11/conference-posters/Wed, 25 Nov 2009 11:42:36 GMTWed, 25 Nov 2009 10:57:14 GMTWed, 25 Nov 2009 11:42:35 GMT6194Working with partner companies to define, execute and deliver a clinical research project can be a challenge at the best of times. So what is it that sets successful projects apart from those that struggle to get started or lose focus during their execution? Recent ‘project fractures research’ into this topic reveals that the root causes of project failure (or significant variance) don’t lie in the project management methodologies or structure. The root causes actually lie in the people factors, such as howhttp://www.icr-global.org/crfocus/2009/20-11/project-fractures/Wed, 25 Nov 2009 11:40:41 GMTWed, 25 Nov 2009 11:15:27 GMTWed, 25 Nov 2009 11:40:40 GMT6195Paul Thompson is Director of Business Development and Susan Ollier HonFICR CSci is Director of UK Operations at QED Clinical Services. Many readers of CRfocus will know Susan better as Chair of ICR until she reached the end of her term at this year’s AGM, but she also ran a consultancy which recently merged with QED Clinical Services. We discuss the company’s franchise business model, the importance of cultural fit and the importance of commercial and operational innovation in the CRO sector.http://www.icr-global.org/crfocus/2009/20-11/cro-interview/Wed, 25 Nov 2009 10:47:06 GMTWed, 25 Nov 2009 10:37:03 GMTWed, 25 Nov 2009 10:47:03 GMT6190Resilience is the ability to stay balanced and to bounce back quickly from setbacks and adversity. Resilient people stay committed and increase their efforts when the going gets tough. Some people are born naturally more resilient than others, but anyone can improve their resilience through effective awareness and training. This article will give you ten simple ideas for becoming more resilient to the ever-changing world around you and reassure you that a key aspect of being resilient is knowing that althouhttp://www.icr-global.org/crfocus/2009/20-11/being-resilient/Wed, 25 Nov 2009 10:33:26 GMTWed, 25 Nov 2009 10:23:34 GMTWed, 25 Nov 2009 10:33:26 GMT6187Christopher Colombus, Kevin and Perry, men from Mars and women from Venus were all mentioned at the ICR forum on ‘A Marriage Made in Heaven or Grounds for Divorce: Exploring the interface between Project Management, Data Management and Statistics.’ This forum took the form of a debate on the motion “The data management and statistics functions are well managed by project management”. Following the formal debate, there was plenty of time for discussion between the speakers and audience. Sarah reports…http://www.icr-global.org/crfocus/2009/20-11/project-management-vs-data-management/Tue, 24 Nov 2009 10:41:12 GMTTue, 24 Nov 2009 10:34:17 GMTTue, 24 Nov 2009 10:41:11 GMT6179Arguably the world’s foremost debating chamber, the Oxford Union was the scene of this annual event, which always addresses contentious issues for the pharmaceutical industry. The Motion for this year’s debate was: “This house believes that there is an unacceptable conflict of interest when pharma conducts trials on its own drugs”. Les Rose was there, and presents the main arguments for and against the motion, and reveals the (not unexpected) result of the evening’s vote.http://www.icr-global.org/crfocus/2009/20-11/pharmatimes-oxford-debate/Tue, 24 Nov 2009 10:29:20 GMTTue, 24 Nov 2009 10:09:29 GMTTue, 24 Nov 2009 10:29:19 GMT6175It is impossible for anyone to replicate the direct experience of all our members, not having worked in every sector. However, as Janette explains, she tries to understand the major issues affecting you and encourage you to become more involved yourself as opportunities arise for influencing the shape of clinical research. It is always interesting to learn that the challenges we face are often similar despite our diverse therapeutic fields and specialisations.http://www.icr-global.org/crfocus/2009/20-11/varied-interlinked-challenges/Tue, 24 Nov 2009 09:52:26 GMTTue, 24 Nov 2009 09:51:14 GMTTue, 24 Nov 2009 09:52:25 GMT6173