Health economics
Alan Jones
NICE’s growth pains continue to be watched assiduously by many outside the UK. This was particularly the case over much of 2007, when the House of Commons Health Select Committee (HSC) held its second inquiry into NICE. Alan Jones examines the results of their inquiry, the Government’s response and what all this might mean for readers of CRfocus.
Feature
Andrew Smith
The 20th DIA EuroMeeting had a broad scope, discussing strategic issues in clinical research alongside statistical, regulatory and other aspects of the wider drug development process. In contrast with the ICR conference, the DIA meeting took less of a view of practical matters related to individual study sites, making the meeting an interesting complement to our own meeting. Andrew Smith presents some of the conference sessions…
Ten Things You Need to Know About...
Medical Devices
ICR Medical Devices SIG
The third article in a series in which experts provide introductions to topics that are becoming increasingly important, and that clinical research professionals will need to know more about in the coming years. The authors discuss medical devices, which have some subtle and significant differences from the clinical trial process in pharmaceuticals.
National update
Emma Fountain MICR & Sine Littlewood
Can industry collaborate with the emerging UK Clinical Research Networks (UKCRN) to achieve high recruiting and excellent quality clinical research, making the UK a more valuable contributor to international studies? The authors present a case study where involving a network ‘turned around’ the UK arm of a global study, and suggest how this type of collaboration could be made even more effective in future.
Professional development
Broaden Your Horizons: Report from the ICR CTA Workshop
Judi Eaton
Judi reports on the most recent workshop in the “Maximise Your Potential” series for clinical trial administrators, covering an overview of research ethics, a comparison of different roles at the study site and sessions on communication and pro-activeness.
Appraisal: An Effective Tool for Professional Development
Joseph Chiesa FICR & Barbara Williamson
An appraisal gives the opportunity to reflect on personal role and how effectively it has been played. The retrospective analysis of what went well and what needs to be improved can often be used to identify how specific improvements could be made. Taking a more prospective view, an appraisal can identify training and development needs, and also help to project what the staff member will be doing in a given period of time so that appropriate development can be planned. The authors describe how to give an effective appraisal.
Viewpoint
Andrew Smith
A recent review has found that a growing number of oncology studies have been stopped early for benefit, with the data being used to support marketing applications. For a successful treatment, this widens the group of patients who could benefit while reducing total study costs and accelerating the drug to market. However, this also increases demands on the statistical robustness of the study. Andrew Smith surveys this ethical, scientific and commercial minefield.
People
Introducing the New Directors of ICR
Tina-Jane Adams MICR & Helen Springford MICR
Two members of ICR were elected to the Board of Directors at last month’s Annual General Meeting. Each of those members, Tina-Jane Adams and Helen Springford tells us about their background in clinical research, how they came to be involved with ICR, and some of the ideas and goals for their terms of office on the Board.
Recruiting & Retaining Great Clinical Research Professionals
An Interview with Linda Christmas
Linda Christmas, Executive Vice President Resourcing Solutions at Chiltern, discusses the state of clinical research staffing and the recruitment market, and the challenges of building, developing and retaining an excellent team.
Regular update
Susan Ollier MICR
Susan Ollier gives her update from the ICR Board of Directors, reiterating the importance of feedback, comments and suggestions from throughout the ICR membership.
