CRfocus: Table of Contents of June 2009 issue

CRfocus 20(06) – June 2009

This is the Table of Contents of Clinical Research focus 20(06) for June 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.In previous years, we have endeavoured to publish reports on all conference sessions in this issue. However, due to constraints on page space and available reporters, we have decided to publish a balanced selection of reports in print, with others (and extended versions of printed reports) becoming available here during June.

Conference photo-gallery

Photos uploaded during the meeting, plus many additional images

Plenary sessions

Lively Debates & Votes:Day One Plenary Sessions

• Niall Dickson, Prof. Karol Sikora, Prof. Nick Bosanquet, Francis Crawley & Colin Miller FICR CSci
• Reporter: Suheila Abdul-Karrim MICR Csci

Pharma 2020: VirtualR&D

• Kate Moss
• Reporter: Andrew Smith

Lively Debates & Votes: Day Two Plenary Sessions [online only, coming soon]

Sharing knowledge

Off-Shoring in ClinicalResearch [extended version, online only]

• Prof. David Jefferys & Paul Wathall MICR
• Reporter: Wendy Tomlinson MICR

Stem Cells: Current Advances & Applications

• Prof. Peter Andrews & Prof. Malcolm Alison
• Reporter: Jane Pelly MICR Csci

Contracts in Global ClinicalTrials

• Rebecca Sergeant & Sarah Watts
• Reporter: Judit Varkonyi-Sepp MICR Csci

Electronic Data Capture (EDC): Issues & Practical Solutions [online only, coming soon]

The A-Z of Adaptive Study Design [online only, coming soon]

Fundamentals of PIPs [online only, coming soon]

Therapeutics

Oncology Care in the Future [extended version, online only]

• Prof. Angus Dalgleish, Prof. Nicholas James, Prof. Jonathan Waxman & Prof. Will Steward
• Reporter: Shethah Morgan MICR Csci

The Heart of Cardiology

• Dr Mike Mullen & Dr Marcus Flather
• Reporter: Sue Jackson RICR

The Heart of Cardiology [extended version, online only coming soon]

Organ Transplantation: Past, present & future [online only, coming soon]

Raising standards

The Impact of theDeclaration of Helsinki

• Eva Nilsson Bagenholm MD & Bev Holt MD
• Reporter: Rachael Winter RICR

Quality & Productivity:Can You Have Both?

• Alison Messom MICR & Andrew Borrisow
• Reporter: Wendy Tomlinson MICR

Evidence for Good Quality:The Hidden Cost of Inspection

• Prof. Richard Gray & Joan Perou HonFICR
• Reporter: Suheila Abdul-Karrim MICR Csci

International Inspections [online only]

• Fergus Sweeney & Gunnar Danielsson
• Reporter: Judit Varkonyi-Sepp MICR CSci

Putting a Price on Patient Value [online only, coming soon]

Inspectors: Why Do They Do It? [online only, coming soon]

Developing professionals

Medical Devices Workshop [online only, coming soon]

Image in Business: It’s Personal [online only, coming soon]

Project Management Workshop [online only, coming soon]

Leadership Workshop [online only, coming soon]

Regular updates

Session Reports from theICR Annual Conference: Message from the Chair

• Janette Benaddi MICR Csci

CRfocus: Contents of December’s issue (vol. 19 no. 11)

Apologies that this is appearing a few weeks late, because of the illness through much of December, leading up to the Christmas break. December’s issue of CRfocus (vol. 19 no. 11) was published on December 8th 2008, and included the following articles. Members of The Institute of Clinical Research are able to click through these links to read the full text of the articles.

Future of Clinical Research

The Future of Clinical Research: Predictions & Hopes from Across the Clinical Research Community

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.

Feature

Are We Speaking the Same Language?: ICR Project Management Forum

Tanya Palmer MICR

In our business- and technically-focused work environments, we often fail to take into account the impact of culture, either through oversight or simply due to a lack of training. This forum aimed to give us the tools to put this right, and Tanya reports…

What Every Freelancer Should Know! ICR Freelance Forum

Helen Glenny HonFICR Csci

Helen Glenny reports from November’s meeting of the ICR Freelance Forum, which discussed tax status, GCP and FDA inspections, pharmacovigilance and a regulatory update

The Who, What, When, Where & How of Investigator Site Training: ICR Trainers’ Forum

Sue Matthews MICR

The ICR Trainer’s Forum showed excellent attendance, with 85 enthusiastic participants turning up on October 8th, to listen and discuss as well as participate in a workshop on investigator site training within clinical research. Clearly, this was a subject of interest and importance with representatives from pharmaceutical companies, CROs, NHS and academia attending.

Stem Cell Research & Neurodegenerative Diseases: ICR Innovative Medicines Forum

Frances Sanders RICR & Rosalyn Forsey RICR

The second Innovative Medicines SIG forum of 2008 addressed the topic of stem cell research and its potential for use in the treatment of neurodegenerative diseases. The meeting provided an excellent insight into the fascinating and complex world of stem cells.

Partnership in Clinical Trials: Conference Report

Andrew Smith

The “Partnerships in Clinical Trials” took place in Berlin on November 5th and 6th, to discuss issues related to the globalisation and outsourcing of clinical research. This report presents highlights of some of the sessions, based on live coverage of the meeting on the CRfocus blog.

People

Breaking the Mould: An Interview with Neelam Patel

Andrew Smith interviews Neelam Patel, Clinical Operations Manager at Lilly UK. They discuss her unique career path, innovation in the way Lilly is conducting clinical research, the challenges of resourcing studies and the evolving role of the CRA.

Professional development

Book Review: Are You Thinking of a Career in Regulatory Medical Writing

Reviewed by Samantha Hamilton

Book Review: A Quick Guide to Clinical Trials For People Who May Not Know it All

Reviewed by Joy Dummer MICR,  Jessica Giles & Lynda Golightly RICR

“If You Raise the Water Level, Everybody’s Boat Floats!” Increasing the Talent Pool Resourcing Clinical Trials

Linda Powell & Greg Holt

There is no shortage of examples illustrating creative methods of attracting and retaining skilled staff in today’s challenging marketplace. As candidates are required to ‘hit the ground running’, competition between companies is fierce to entice experienced clinical research professionals. Linda and Greg discuss…

Regular update

Benefits for ICR Members… and Who Else? – Message from the Chair

Susan Ollier MICR

Susan Ollier discusses who benefits from ICR’s existence, and suggests that it’s not just us, the members. In improving the conduct of clinical research, we are delivering public benefit, and perhaps we are too reticent about communicating this.

CRfocus 2008 Article Index

Ask Suzanne Watt about stem cell research…

Next week I’ll be interviewing Suzanne Watt, Head of Stem Cell & Immunotherapies at the UK National Blood Service. We’ll be talking about the issues around collecting and using stem cells and their implications for clinical research. The interview will be posted as an mp3 on the CRfocus website (www.crfocus.org) and selected portions published in a forthcoming issue of Clinical Research focus.

If you’d like to suggest a question or topic for discussion, please let me know by lunchtime on Monday, August 11th.