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CRfocus 20(12) - December 2009

CRfocus 20(12) front cover

This is the Table of Contents of Clinical Research focus 20(12) issue for December 2009.

Future of Clinical Research

High Aspirations & Mixed Expectations: Assessing the Future of Clinical Research

Compiled by Andrew Smith

A 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.

2009 in review

Some ICR Highlights of 2009: Message from the Chair

Janette Benaddi MICR CSci

Janette looks back at what ICR has done over the past 12 months and talk about some of the highlights of this year. Although it has been a difficult year for ICR, with the recession impacting some areas of our organisation, there have been many highlights and I feel as we go into a new year it is these successes that we should be celebrating.

Clinical Research Highlights of 2009

Andrew Smith

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 this recession is gone and forgotten.

2009 Article Index

We 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 published in CRfocus since 2001, now amounting to well over 700 articles. We also present our editorial themes for 2010, from Offshoring and Early phase to Governance of research and the potential for “EU Directive 2.0”.

Features

To File or Not to File... & Other Questions: ICR Freelance Forum

Danielle Jacobs

A 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.

GCP Discussion: Pregnancy of Research Subject’s Partner

Nicky Dodsworth MICR CSci & the ICR GCP Forum Steering Group

Questions 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.

Don’t Panic, It’s Not All That Bad! Employee Confidence Survey

Catherine Gutsell

Following 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.

People

A British Medic in Global Big Pharma: An Interview with David Gillen

Interviewed by Andrew Smith

David 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. An audio version of the complete interview, including additional material not covered in this transcription, is available from the CRfocus website (www.crfocus.org).

Prof. development

Launch of the ICR Clinical Trial Administrator Manual: Written for CTAs by CTAs

Rebecca Garland & Judi Eaton

The 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.

Regular update

It's Not All Work, Work, Work…

Compiled by Andrew Smith

We take a festive look at the lighter side of clinical research, including Christmas carols adapted for use by clinical research professionals and “Ten things we wouldn’t want to receive from Secret Santa at the departmental Christmas Party”.


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