Optimising site performance
Clive Jenkins FRQA
It could be argued that confirmation of the accuracy of data is the most important aspect of clinical research. Yet analysis of over 400 investigator audits identified SDV deficiencies in over 75%. Clive Jenkins suggests changes to study design and conduct to improve the standard of SDV.
CRAs Can Take the Lead: Tips for CRAs to Lead Improvement in Site Performance
Iain Searle MICR
Whose job is it to optimise the performance of a clinical research site? Is it fair to judge CRAs on the performance of their sites? Iain Searle discusses things that a CRA can do, that can have an impact on site performance.
Research ethics
Is Consent Enough? Issues in Patient Safety and Data Protection
Prof. Hazel Biggs
Hazel discusses the role of consent in clinical research and suggests that, in many respects, UK law is imperfect in protecting the rights of research participants and promoting autonomy and does little to enforce ethical best practice.
Ethical Science is Best Seen at the Micro Level
Stephen Humphreys
Stephen argues that ethical opinion is a “non-science” and attempts to explain divergences of opinion amongst ethics committees and their members. He also suggests a way in which researchers can aid the same committees to reach their determinations in a manner that also assists the researcher.
Feature
NICE conference report
Alan Jones
Alan presents his regular report from the NICE conference, at the end of a watershed year, what with the controversy over Herceptin, winning the judicial review over the Alzheimer’s disease drugs, more risk-share schemes and the second House of Commons Health Select Committee Inquiry.
People
The Media in Communication of Scientific Fact, Conjecture & Risk
Claire Bithell
Claire will be giving the keynote address at ICR’s Annual Conference. In this interesting interview, she gives prospective delegates an idea of what to expect from this interesting, informative and challenging session.
Viewpoint
Drug Development Isn't a 'Perfect' Market
Andrew Smith
Andrew Smith thinks that the recent EU anti-trust enquiry into the pharmaceutical sector might be looking for the wrong thing, in the wrong place.
Regular update
Call for Nominations to the ICR Board of Directors
John Hooper
ICR is your organisation, and John Hooper calls for nominations, by February 15th, for the one vacant seat on the ICR Board of Directors.
