This is the Table of Contents of Clinical Research focus 20(09) issue for September 2009.
Feature
Compiled by Andrew Smith
ICH guideline E6 (ICH-GCP) is, along with the Declaration of Helsinki, arguably the most important document in clinical research. Since its adoption in 1996 (in Europe; 1997 in the USA and Japan), ICH GCP has been the ‘bible’ for CRAs, auditors and other clinical research professionals worldwide. However, the world of clinical research has moved on quite some way in the past 13 years. Following a remark made by a speaker at this year’s ICR Annual Conference, we wondered whether ICH E6 should be reviewed and potentially revised. We undertook a qualitative survey, asking all CSci and FICR members what elements of the guideline should be updated and/or what should be added that did not exist in 1996. We present some of the most interesting and provocative comments.
People
Rob Davie PhD MICR
Dr Robert Davie is Vice President and General Manager, Europe, for Clinical Development at Covance. In this interview with Andrew Smith, he talks about the current period of innovation in outsourcing arrangements, the challenges of long-term global partnerships between CROs and pharmaceutical companies, learning lessons from other industries, differences between ‘old’ and ‘new’ Europe and the ‘flattening’ of the world of developing medicines.
Stewart Hulse
Stewart Hulse is Director of Recruitment Services for Novella Clinical. In this brief interview with Max Golby, he discusses what has happened to the once-great well of monitoring expertise, and what has led new CRAs to chase the ladder of promotion as fast as employers will allow. He calls for better rewards for long-term CRAs to retain that expertise and points out that going freelance too early can actually be a career-limiting move.
National updates
Angus E Donald LLM HonFICR
In the latest in a series of letters from his new home in the USA, long-time ICR member Angus Donald reports on some of the significant changes around clinical research and healthcare in general that are taking shape in the first few months of the presidency of Barack Obama. The past few months have seen considerable changes in the landscape of pharmaceutical development in the US and indications suggest that these radical changes, both in administrative policy and litigation, will continue during the current administration. Angus discusses the changes in funding for basic medical research, including human embryonic stem cells, financial incentives for innovation, an expanded budget for the FDA, and closing loopholes on ‘exclusion payments’ on generics. He also goes into detail on the issue of pre-emption, and discusses the implications of the recent US Supreme Court ruling on
Wyeth v Levine.
Graeme Scott HonFICR CSci
The ICR Scottish Forum is now in its ninth year and it is clear from attendance figures that it continues to offer what ICR members want. A healthy 70 or so of us attended the forum’s February meeting to listen to Dr Clare Morgan, Dr Matthew Cooper and Dr Roma Armstrong tell us about the progress and performance of the Research Networks both North and South of the border. There was the usual opportunity for awkward questions and healthy debate. Graeme Scott presents this report, which is equally relevant for those of us working outside Scotland.
Prof. development
Polan Chetty & the ICR CRA Special Interest Group
When Polan Chetty and her colleagues in the ICR CRA Special Interest Group started writing this article, they tried to describe a typical week in the life of a Clinical Research Associate. However, any CRA will tell you that there is no such thing as a typical week. If you are hoping for a straight 9 to 5 job, you are not going to find it here. While the few days described are fictional, they are entirely realistic…
Viewpoint
Andrew Smith
The counter-balance to increasing constraints on NHS spending on pharmaceuticals comes in the form of various initiatives to make more of a contribution in terms of investment by the UK government in education and training, infrastructure and organisational processes. The latest of these is the Office of Life Sciences (OLS) Blueprint, which was published over the summer. The Blueprint sets out 12 key action points, expanded to 10 pages of specific policy measures, complete with timelines and budgets, of which the policy that will be of most interest to us is the “package of measures to improve the UK environment for clinical trials”. The Blueprint has been widely welcomed by industry and commentators alike. Andrew offers “two cheers” but also sounds a note of scepticism…
Regular updates
Janette Benaddi MICR Csci
This month, as many of us return from our summer vacations, Janette Benaddi shares more information on the demographics of the entire ICR membership. If you have had the opportunity to attend our Annual Conference you will have experienced at first hand the diversity of our members and will have perhaps been astounded by the different fields our members work in. As an Institute for professionals it is important we try our best to cater for all our members whether minority or majority. You may think that with such diversity in roles and affiliations this might be difficult. However, what is interesting to one group of members will often be interesting to others. We have recently adjusted the membership prices to more closely reflect the costs to serve our members and help to bring us more in line with other professional bodies. We are looking at new ways of serving the specialist groups and are constantly striving to improve our service offerings.
Compiled by Andrew Smith
Our regular look at the lighter side of clinical research, including some unlikely holiday destinations for clinical research professionals, some possible side effects we might not need to be quite so worried about, and “Ten news stories that weren’t covered by the world’s clinical research media”.
