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