Re-Tooling the Development Environment
Andrew Smith
To make step-change improvements to the whole drug development landscape, it is as much the landscape itself that must be re-engineered as the companies operating in it. This has been widely acknowledged and many countries, regions and organisations are trying to re-tool their development environments accordingly. Many of these initiatives have already been reported in CRfocus, but this article brings them together to present a whistle-stop tour of some of the most important re-tooling projects, to shed some light on where global clinical development is going, and how soon we might get there.
Tim Ewbank
Harten Group’s sixth annual survey canvassed executives’ views of the issues currently facing the industry in 2008. It compared their forecast for 2007 with how the year played out in reality, surveying over 600 executives in pharmaceutical and biotech companies (divided roughly four to one respectively) in December 2007. Tim Ewbank presents some of the most interesting results.
Angus E Donald HonFICR
Angus Donald reports on the current status of the regulatory environment in the USA and help bridge gaps which may harmonise clinical trials and allow for mutual recognition. He looks at the Food and Drug Administration Amendments Act of 2007, which sets out the strategic priorities for the FDA over the next 5 years.
Ten Things You Need to Know About…
Frank Bretz & Werner Brannath
The second item of 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 adaptive designs, which are thought be some to hold the key to more efficient and effective studies.
National Update
Mary Mumford RICR
What brings nearly 100 ICR members from as far afield as Wiltshire and Belfast to a Scottish Forum meeting in Edinburgh? In November 2007, the answer was to find out what MHRA inspectors are finding during their inspections. Mary Mumford was there…
Andrew Rose RICR
Due to the limited numbers of paediatric studies that have been conducted in the past, the National Institute for Health Research Medicines for Children Research Network has recently been created to improve the co-ordination, speed and quality of randomised controlled trials and other well designed studies of medicines for children and adolescents. Andrew describes the work of the MCRN, and how it can help your paediatric studies.
Viewpoint
Andrew Smith
Andrew discusses the current popularity of transparency and registries, and wonders whether the same idea might be applied to the authors of papers in medical journals.
Prof. development
Andrew Smith
The evening of February 28th was the culmination of a competition that had been going on for over a year, to find the best clinical research professionals in the world. At a ‘black tie’ dinner at the luxurious InterContinental Hotel on London’s Park Lane, over 400 clinical researchers came together to celebrate their excellence, and to see which of them would walk away with the prestigious PharmaTimes Clinical Researcher of the Year awards. Andrew Smith reports…
Regular update
Susan Ollier MICR
Susan Ollier presents ICR’s 2008 European Conference, and explains how a meeting on “winning strategies for Europe” could actually benefit everyone.
