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2009 Article Index

Compiled by Andrew Smith

Keywords

Article index, CRfocus, ICR updates, Miscellaneous, National updates, People, Process & quality, Professional development, Regulatory & ethics, Therapeutics

 

This has been a strong year for Clinical Research focus, coping with the difficult business climate, both in the broader economy and in the clinical research sector in particular. 


We have published nearly 100 articles on a wide variety of topics throughout this year. It would be folly to deny that we have been struck, like every other publisher, by the difficult trading conditions, and this has led to about 100 fewer pages across the year. However, we have taken this 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.

In adition, we have also given you 35 pages of news (in print, on the ICR website and in fortnightly email bulletins) and our new lighter section “It’s Not All Work, Work, Work”. Almost all the feedback we receive from readers is been positive. Of course, we would love to learn more of what you think of your ICR members’ journal, both positive and (if we deserve it) negative. As usual for the last issue of the year, we have taken this opportunity to give you a complete overview of the subjects we have covered. You can also download this index from the CRfocus website (www.crfocus.org), along with annual indexes going back to 2001 and individual Tables of Contents (including abstracts) for each issue this year.

The grouping of the articles in this index has been somewhat arbitrary, and many of the articles would fit into more than one category. Within each subject area, the articles are ordered chronologically and then by author. As we started doing in 2008, every article includes keyword classifications; these are the same keywords used on our Online Database of Information & kNowledge (ODIN), found via our website, so you can easily find related articles on topics that interest you.

Don’t forget, one of the many benefits of ICR membership is that you have full access to our online archive, containing almost every article published in CRfocus since 2001, now amounting to well over 700 articles. Our monthly CPD Quiz has also gone from strength to strength, helping you test your understanding and recall of topics discussed in earlier issues; you can measure your own performance and earn two CPD points for each quiz on which you score 70% or better… and also enter our prize draw to win a bottle of Champagne!

2009 article index

Regulatory & ethics

  • The Impact of the EU Clinical Trials Directive: Report from the ICREL Conference, Andrew Smith, 20(02) p25
  • Measuring the Impact of the EU Clinical Trials Directive: An Interview with Ingrid Klingmann, Ingrid Klingmann, 20(02) p31
  • Research Integrity vs Getting the Joke, Andrew Smith, 20(03) p6
  • Research Integrity: A European Perspective: EFGCP conference report, Andrew Smith, 20(04) p29
  • Strengthening Protection of Research Subjects: The 2008 Revision of the Declaration of Helsinki, John Poland FTOPRA, 20(05) p7
  • The Impact of the Declaration of Helsinki, Rachael Winter RICR, 20(06) p33
  • EudraCT Upgrades to Version 7, Andrew Smith, 20(07) p16
  • Still Relevant After All These Years? Should ICH GCP be Reviewed & Revised?, Compiled by Andrew Smith, 20(09) p7
  • GCP Discussion: Pregnancy of Research Subject’s Partner, Nicky Dodsworth MICR CSci & the ICR GCP Forum Steering Group, 20(12) p27

Process & quality

  • Ten Things You Need to Know About Phase I Clinical Trials, Harriet Wibberley MICR & the ICR Clinical Pharmacology SIG, 20(02) p34
  • Adjust the Focus on Recruitment & Retention: Enabling CRAs to Develop & Implement Site-Specific Plans, Sherry Armstrong-Wilkinson MICR, 20(03) p7
  • Exploring Patient Recruitment: NIHR Primary Care Research Recruitment Methods Group, Elaine Ward, Julia Miller & Brendan Delaney, 20(03) p11
  • Factors Driving the Evolution of Digital Outreach for Patient Recruitment, Gaynor Anders, Mary Schwarz & Jake Perez, 20(03) p15
  • Real World Data: An Important Addition to Your Late Phase Development Plans, Samantha Marshall, 20(03) p27
  • Investigating Serious Non-Compliance: Planning & Conducting For-Cause Audits, Nigel Crossland FICR Csci, 20(04) p19
  • Always Compete on Value; Never on Cost, Andrew Smith, 20(05) p6
  • Lost in Translation? Challenges in Preparing Participant Information for Multilingual Studies, Nicky Dodsworth MICR CSci & Efraim Roe, 20(05) p21
  • Pharma 2020: Virtual R&D, Andrew Smith, 20(06) p9
  • Off-Shoring in Clinical Research, Wendy Tomlinson MICR, 20(06) p16
  • Contracts in Global Clinical Trials, Judit Varkonyi-Sepp MICR Csci, 20(06) p23
  • Quality & Productivity: Can You Have Both?, Wendy Tomlinson MICR, 20(06) p36
  • Evidence for Good Quality: The Hidden Cost of Inspection, Suheila Abdul-Karrim MICR Csci, 20(06) p40
  • The Evolution of Outsourcing: Contract Management Coming of Age, Andy Parrett, 20(07) p7
  • CDISC European Interchange 2009: Conference Sketch, Adam Jacobs FICR CSci, 20(07) p19
  • Quality Assurance: Friend or Foe? A Survey, Jan Robinson MICR CSci, 20(07) p24
  • Writing Protocols: Collaboration & Compromise or Conflict & Confusion? ICR/EMWA Joint Symposium, Alex Dedman & Andrew Smith, 20(07) p25
  • International inspections, Judit Varkonyi-Sepp MICR CSci, 20(07) p33
  • Multinational Trials: A New Balance Point?, Andrew Smith, 20(10) p7
  • My Clinical Study is Over; What Happens to the Data? An Introduction to the Clinical Study Report, Emily Scott, 20(10) p21
  • Ten Things You Need to Know About Infusion Pumps for IV Delivery in Clinical Trials, Elena Skryabina, 20(10) p28
  • Challenges of Inter-Organisation Projects: What Factors Lead Towards Success?, Matthew Theobald, 20(11) p7
  • An Unacceptable Conflict of Interest? The PharmaTimes Great Oxford Debate, Les Rose FICR, 20(11) p22
  • A Marriage Made in Heaven or Grounds for Divorce: ICR Project Management Forum, Sarah Muller, 20(11) p31

Therapeutics

  • Stem Cells: Current Advances & Applications, Jane Pelly MICR Csci, 20(06) p20
  • Oncology Care in the Future, Shethah Morgan MICR Csci, 20(06) p26
  • The Heart of Cardiology, Sue Jackson RICR, 20(06) p29
  • Organ Transplantation: Past, Present & Future (2), Ali Zataar MICR CSci, 20(07) p29
  • How Will Personalised Medicine Have an Impact on Clinical Trials?, Abel Ureta-Vidal, 20(11) p28

National update

  • Inside IRAS: ‘Real World’ Experiences with the Integrated Research Application System, Susannah Radford, 20(02) p7
  • Streamlining Device Study Contracts: A Model Agreement for Medical Technology Investigations Carried Out in NHS Trusts, Jill Dhell & Mark Lewis, 20(02) p13
  • Building Clinical Research Capability in Nottingham: An Interview with Brian Thompson & Darren Clark, Brian Thomson & Darren Clark, 20(02) p16
  • Health Technology Assessment in the UK & EU: NICE & EUnetHTA Conferences, Alan Jones, 20(03) p35
  • Local & National Perspectives on Streamlining R&D: ICR Scottish Forum, Mary Mumford RICR, 20(05) p29
  • OLS Blueprint: PICTf 2.0?, Andrew Smith, 20(09) p6
  • Changes Across the Pond: Barack Obama, Stem Cells, Incentives & Pre-emption, Angus E Donald LLM HonFICR, 20(09) p21
  • Net Benefits of Working with Networks? The ICR Scottish Forum, Graeme Scott HonFICR CSci, 20(09) p26
  • Managing Clinical Research in the UK: Survey & Conference, Andrew Smith, 20(10) p11

Prof. development

  • Ten Steps to a New You: Thoughts on Continuing Personal Development, Andrew Smith, 20(01) p5
  • Celebrating Excellence in Clinical Research: ICR’s First 100 Chartered Scientists, Compiled by Andrew Smith, 20(01) p14
  • Resourcing in Crisis? ICR Resourcing Forum, Max Golby, 20(01) p21
  • It’s Achievable: Balancing Higher Education with Work, Helen Dixon, 20(01) p26
  • Pharmacy as a Career in Clinical Research, Caroline Bedford MICR & Sheila Hodgson MICR, 20(02) p36
  • The Insider’s Guide to Being a Successful CRA/Monitor, Lynn Seeley MICR & Irene Lee MICR, 20(02) p41
  • Tools & Updates: CTA Workshop Report, Judi Eaton, 20(04) p35
  • Spice Up Your Interview Technique, Shanoo Singh, 20(05) p17
  • A Good Job, A Good Career: ICR Members’ Thoughts on Career Progression, Compiled by Andrew Smith, 20(08) p3
  • Trials & Tribulations of Monitoring: A Week in the Life of a CRA, Polan Chetty & the ICR CRA Special Interest Group, 20(09) p33
  • Study Management for Research Nurses: ICR Research Nurse Forum, Nicky Perry MICR, 20(10) p25
  • Virtual Learning in the Real World: ICR Tainers’ Forum, Iain Searle MICR CSci, Merryn Collard RICR & Jane Nathan RICR, 20(10) p33
  • ASM Posters: 2009 Entries & 2010 Submissions, Andrew Smith, 20(11) p17
  • 10 Things You Need to Know About... Being Resilient at Work, Helen Chapman, 20(11) p26
  • To File or Not to File... & Other Questions: ICR Freelance Forum, Danielle Jacobs, 20(12) p23
  • Launch of the ICR Clinical Trial Administrator Manual: Written for CTAs by CTAs, Judi Eaton, 20(12) p29
  • Don’t Panic, It’s Not All That Bad! Employee Confidence Survey, Jonathan Hart-Smith, 20(12) p31

People

  • Our 100th Chartered Scientist: An Interview, Graham Belgrave MICR Csci, 20(01) p18
  • Championing Clinical Research in High Places: An Interview, Lord Howe, 20(01) p24
  • Planning for Success in Patient Recruitment: An Interview, Missy Orr, 20(03) p20
  • A Career Championing UK Clinical Research: An Interview, Richard Tiner, 20(05) p25
  • Why You Should Care About the Innovative Medicines Initiative: An Interview, Jackie Hunter (interviewed by Edward Blair MICR), 20(07) p21
  • A Leader of CRO Innovation & Growth: An Interview, Rob Davie PhD MICR, 20(09) p17
  • Where Have All the Career CRAs Gone? An Interview, Stewart Hulse, 20(09) p31
  • Exploring an Innovative CRO Business Model: An Interview, Susan Ollier HonFICR CSci & Paul Thompson, 20(11) p19
  • A British Medic in Global Big Pharma: An Interview, David Gillen, 20(12) p19

ICR updates

  • Lively Debates & 70s Flares: Message from the Chair, Susan Ollier MICR Csci, 20(01) p4
  • Raising Big Issues in High Places: Message from the Chair, Susan Ollier MICR Csci, 20(02) p5
  • So Long, Farewell, Auf Wiedersehen, Goodbye…: Message from the Chair, Susan Ollier MICR Csci, 20(03) p5
  • Essential Updates & Lively Debates: ICR Annual Conference Preview, Compiled by Andrew Smith, 20(03) p33
  • Our Institute, Our Future: Message from the Chair, Janette Benaddi MICR Csci, 20(04) p5
  • Uncertainty & Opportunity: Message from the Chair, Janette Benaddi MICR Csci, 20(05) p5
  • Session Reports from the ICR Annual Conference: Message from the Chair, Janette Benaddi MICR Csci, 20(06) p5
  • The Board of Directors: Who Are They & What Do They Do? Message from the Chair, Janette Benaddi MICR Csci, 20(07) p5
  • Make the Most of ICR Online, Andrew Smith, 20(08) p9
  • It’s All About You: Our Members! Message from the Chair, Janette Benaddi MICR Csci, 20(09) p5
  • Fit For the Future: Message from the Chair, Janette Benaddi MICR Csci, 20(10) p5
  • The Challenges We Face: Varied But Interlinked: Message from the Chair, Janette Benaddi MICR Csci, 20(11) p5
  • Some ICR Highlights of 2009: Message from the Chair, Janette Benaddi MICR Csci, 20(12) p5
  • 2009 Article Index, Compiled by Andrew Smith, 20(12) p35

Miscellaneous

  • Unthinkable!, Andrew Smith, 20(02) p6
  • Consolidation or Sea Change?, Andrew Smith, 20(04) p6
  • What a Difference a Year Makes: Survey of Executive Confidence, Tim Ewbank, 20(04) p7
  • Maintaining a Positive Outlook: Survey of Jobseekers, Jonathan Hart-Smith, 20(04) p11
  • Book Review: “The Trouble with Medical Journals”, Reviewed by Debbie Early MICR, 20(04) p26
  • Devices, Drugs, Directives & Directors, John Kolthammer HonFICR, 20(05) p33
  • Lively Debates & Votes: Day One Plenary Sessions, Suheila Abdul-Karrim MICR Csci, 20(06) p6
  • Book review: “Trial by Fire: Lessons from the History of Clinical Trials”, Reviewed by Debbie Early MICR, 20(10) p31
  • Clinial Research Highlights of 2009, Andrew Smith, 20(12) p6
  • High Aspirations & Mixed Expectations: Assessing the Future of Clinical Research, Compiled by Andrew Smith, 20(12) p7

2010 editorial themes

In closing CRfocus for 2009, it is also worth reiterating a general call for papers and expert reviewers. Topics that we are particularly looking to cover in 2010 include:
  • Career development supplement ( January)
  • Therapeutic updates (February)
  • Biotech development (March)
  • Offshoring/globalisation (April)
  • Early phase innovation (May)
  • Medical devices ( June)
  • Annual Conference reports ( July)
  • Career development supplement (August)
  • Governance of research (September)
  • EU Directive 2.0? (October)
  • Paediatrics (November)
  • The future of clinical research (December)

Clinical Research focus is always keen to publish papers by members of the Institute, so if you have a ‘burning desire’ to write on any topic (even if you feel you lack the experience of writing for publication), please contact me.

The CRfocus Editorial Advisory Board, International Correspondents and I are proud of the work we have done for you this year. We’re looking forward to being able to explore even more exciting topics for you in 2010, and to watching some of the ideas discussed in this issue as they develop over the coming months.

Finally, I would like to take this opportunity, on behalf of all of us on the CRfocus Editorial Advisory Board, and in the Institute office, to wish you a Merry Christmas and a happy, and productive, New Year.

 

Andrew Smith (andrew.smith@crfocus.org) is Editor of Clinical Research focus.

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