Clinical Research insights from CRfocus

Blogging for Clinical Research focus, the journal of The Institute of Clinical Research

Posts Tagged ‘stem cells’

Science, Society & Economics: Shaping the Future of Clinical Research: ICR 31st Anniversary Conference & Exhibition

Posted by Andrew Smith on March 29, 2010

It’s that time of year again: here at the ICR office, we are making the final preparations for our Annual Conference, which is just a few weeks away on April 19th and 20th. The conference is ICR’s flagship event, and a high point of the year for clinical research professionals. Delegates, speakers and exhibitors come to learn about and discuss the issues facing professionals in their work designing, managing and conducting clinical trials.

The past couple of years have been challenging for us all, in terms of time and budget to invest in our professional development and networking. We’ve listened to your feedback about previous ICR conferences, and have built on the changes we introduced last year to give you the best event possible, with a programme of relevant and informative sessions for all the diverse roles making up the ICR membership. The 2010 ICR conference makes it easier for you to reconnect with your profession, and create new opportunities for yourself and your company.

After several years in the centre of England, we are bringing the conference to London for the first time in its history. This recognises the fact that more than half our members live within a couple of hours of the city. The Hilton Metropole, a few minutes away from Paddington station, is within easy reach of national and international transport services, whether you’re coming by car, train or plane.

For the first time in nearly a decade, the conference will be held in the hotel where most of the delegates, speakers etc. are also staying. This meant that we were able to offer delegates who booked their places early preferential rates on their hotel reservations. You also have the benefit of being able to carry on discussing issues after the conference formally closes, at our networking drinks reception on the Monday evening, in the bar or over dinner, or even over a shared breakfast before the second day of the conference opens.

Another important change is that we’ve frozen delegate prices to remain at their 2009 levels, to help members in these challenging economic times. This makes the ICR conference even better value for money than other multi-stream conferences.

If you can only go to one conference…

This year, we have a varied selection of relevant, knowledgeable and experienced speakers to discuss the important issues facing us all. All of the topics to be discussed at this year’s conference will impact on the way you work now and in the future, either directly on indirectly. Whatever your role in clinical development, and whatever point you’re at in your career, it’s vital that you stay up-to-date with the latest developments and make your voice heard in the discussions about their implementation, impact and implications.

The overarching theme of the conference is that clinical research is influenced by both internal and external factors, with economics and politics often having as great an impact on the way we work to develop new treatments as developments in medical science and operating procedures. The interfaces between these areas will provide the clinical research community with its greatest challenges, and its greatest opportunities, over the coming years.

Plenary sessions: Personalised healthcare & Health economics

Plenary sessions on key topics will close each day’s proceedings.

In the first of these, speakers from AstraZeneca and Roche will look at personalised healthcare, certainly an indicator for the way many future medicines will be developed and studied. The technological, scientific and clinical advancements in pharmaceuticals R&D over the past decade has ensured that the concept of personalised healthcare is now rapidly becoming the practice of personalised healthcare, particularly in infectious disease and oncology. This important field has implications reaching into patient recruitment and informed consent, pricing and economics, biomarkers and companion diagnostics etc.

The second plenary session will close the conference with a detailed look at the economic evaluation of healthcare technologies, which is increasingly used to inform social choices about access to innovative treatments. This is a field where the UK leads much of global thinking. Professors Richard Lilford and Karl Claxton, both of whom are close to the development of these ideas and their practical application, will discuss which health technologies should be approved or covered for use, what price ought to be paid for such technologies and how much and what type of evidence is required to support coverage or approval. The changing health-economic landscape will have an increasing impact on which clinical development programmes take priority, how individual clinical trials are structured, and how additional kinds of information need to be collected and analysed.

Parallel sessions: From patient recruitment to research governance

There are too many exciting topics being covered in the 12 parallel sessions to discuss them all in detail, but here is a selection of sessions that are proving popular with early-registering delegates:

Dr Clare Morgan of the NIHR Clinical Research Network Coordinating Centre will review what the NIHR CRN is doing to improve reliability, including improving confidence around quality study feasibility assessment, access to a wider pool of committed investigators with dedicated, trained resource to support study delivery and proactive study performance management.

Gaynor Anders and Prof. Theo Raynor urge us to “think outside the box” about patient recruitment. Real progress is being made on several fronts of the challenge to meet the study participation needs of research programs. However, there is still a huge gap between those needs and the collective willingness and ability of patients to enrol in studies.

Mark Lewis MICR and Christine McGrath MICR will explore the challenges and tactics involved in applying policy-level initiatives in practice at individual Trusts, to enhance and streamline UK clinical research. They will also discuss how to improve the performance of individual R&D departments (in terms of quality, speed, added value etc.).

Another key update will come from Janet Wisely of NRES, who will discuss the latest developments in ethics review. She will look at the ongoing development of the IRAS application system, the 2009 pilot scheme in proportionate review, and the use of ethics advisers to help committees work more effectively by ensuring that proposals are well presented, with scientific referees’ reports if necessary.

Other sessions consider practical issues, such as the role of research nurses in the informed consent process, the changing clinical data requirements for medical devices, managing remote teams and the move towards risk-based inspections.

Full abstracts and speaker profiles for all conference sessions are available at www.icr-global.org/community/conferences/31st-annual-conference-exhibition.

Annual General Meeting: May 19th

The ICR Annual General Meeting has traditionally been an important part of the Annual Conference. However, as announced last month and clarified elsewhere in this issue, we have decided that this year’s AGM deserves more time and attention than it can easily be given alongside the conference. Instead, the AGM will be held at the ICR office in Bourne End, on May 19th, starting at 5pm. Further details will be published to members in due course.

More targeted exhibition

In addition to attending conference sessions and networking with your peers throughout the industry, many delegates also come to the conference to find out more about potential new suppliers, and the exhibition has always been an important addition to the ICR conference. This year’s exhibition is already sold out, and we are pleased to have the support of so many companies from throughout the clinical research sector.

However, after listening to your feedback over previous years about the balance of exhibiting companies and the sometimes overly intrusive attitudes of a few individual stand personnel, we have decided to reduce the size of the overall exhibition, and particularly the proportion of recruitment agencies that have been invited to exhibit. Along with our Exhibitors’ Code of Conduct, this means that you will be able to walk through the exhibition aisles without concerns, and decide without pressure which companies you’d like to talk to.

Make the most of your membership

As I write this piece, in March, many of you have already registered to attend the conference, and it is becoming obvious that several of the sessions will be well attended. If you are struggling to find the time (or the budget) to come to the full meeting, we are offering single-day conference passes at reduced rates.

As we hope you’ll agree, this year’s Annual Conference will have something for everyone: plenty to learn, plenty of business benefit, but also plenty for us all to enjoy. We are also offering special reduced rates for professionals working in academia or the public sector, and to full-time students. To reserve your place, simply fax back the form on the back of the conference flyer enclosed with this issue of CRfocus, or register online via the ICR website (www.icr-global.org/community).

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CRfocus: Table of Contents of June 2009 issue

Posted by Andrew Smith on June 3, 2009

CRfocus 20(06) – June 2009

CRfocus 20(06) front cover
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

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

Posted by Andrew Smith on January 2, 2009

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

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Ask Suzanne Watt about stem cell research…

Posted by Andrew Smith on August 7, 2008

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.

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