This is the Table of Contents of Clinical Research focus 20(05) for May 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.
Features
Strengthening Protection of Research Subjects: The 2008 Revision of the Declaration of Helsinki
John Poland FTOPRA
The Declaration of Helsinki was developed to underpin the ethical conduct of human clinical research. Eight years after its previous major update, which prompted two clarifications on contentious points, the Declaration was revised late in 2008 after a process lasting nearly 2 years. John Poland provides a detailed view of the latest revisions, which have provoked mixed responses from regulatory, ethics and clinical communities.
Lost in Translation? Challenges in Preparing Participant Information for Multilingual Studies
Nicky Dodsworth MICR CSci & Efraim Roe
An increasing number of studies are being performed in parts of the world whose first language is not English. There are challenges in translation and communicating science in a multilingual world dominated by the de facto language of English. Nicky and Efraim look at the issues surrounding translation of the patient information and informed consent forms.
People
A Career Championing UK Clinical Research: An Interview
Richard Tiner
Richard Tiner steps down as Medical Director of the Association of the British Pharmaceutical Industry (ABPI) at the end of May, after nearly 13 years in the post. Over that time, he has been a prominent speaker at ICR events, and was the first person we interviewed for CRfocus. As he prepares to move on, he reflects on the changes in the UK clinical trials landscape since the mid-1990s, in which he has been instrumental.
National update
Local & National Perspectives on Streamlining R&D: ICR Scottish Forum
Mary Mumford RICR
Mary reports on the October 2008 meeting of the ICR Scottish Forum. At the meeting, Dr Janet Messer, Deputy Director of the NHS R&D Forum, gave an overview of the initiatives to integrate and streamline R&D activities throughout the NHS, while Brian Rae, R&D Manager of the Greater Glasgow & Clyde NHS Trust, spoke about the successes and challenges in developing world-class clinical research structures in one of the most health-challenged regions of the UK.
Professional development
Spice Up Your Interview Technique
Shanoo Singh
Being interviewed can be a nightmare. Interviewing skills have been rapidly and continuously changing over the past decade. Having been both a candidate and an interviewer on many occasions, Shanoo reaches out to everyone, particularly those seeking their next strategic positions, and offers some tips on how to perform at your best in an interview situation.
Viewpoint
Always Compete on Value; Never on Cost
Andrew Smith
When the economic upturn comes, the individuals, organisations and indeed countries that will be best placed to succeed will be those that have continued developing through the lean times. As an industry, we’ve become very good at working costs out of our processes. However, focusing solely on this risks neglecting importance of creating additional value for companies, shareholders and society as a whole. The relative risk of trying to leap ahead through strategic innovation is actually lower now than in ‘boom’ years, those that innovate and survive will secure their place at the forefront of the industry for a generation.
Devices, Drugs, Directives & Directors
John Kolthammer HonFICR
To recognise that our new Chair of the ICR Board of Directors has a background in medical device development, John Kolthammer, former CEO of ICR, offers a respectful and somewhat light-hearted reminiscence to draw attention to the some of the interesting issues that have always been present at the interface between pharmaceuticals and medical devices.
Regular update
Uncertainty & Opportunity: Message from the Chair
Janette Benaddi MICR Csci
Janette inspires us to remain optimistic and look harder than we have ever done for opportunities, despite any current financial insecurities or media-fuelled gloom. To add personal despondency to this will surely reduce our individual ability to cope, and will probably also make the wider recession both longer and deeper. It’s challenging to look on the bright side, but she believes that there is a bright side for many of us, if we care to search for it.
It’s Not All Work, Work, Work…
Compiled by Andrew Smith
Our regular look at the lighter side of clinical research, including “Ten innovations that won’t add value to sponsors, shareholders or society” and engaging with patients in language that is a bit more “street”…
