The February 2006 issue of Clinical Research focus has just been
published. For more information, visit www.crfocus.org

Private Data, Public Opinions
In their recent report, 'Personal data for public good: Using health
information in medical research', the Academy of Medical Sciences
warns that long-term medical research projects are "increasingly
inhibited by inappropriate constraints on the use of personal health
data". In contrast, in June 2005 the British Medical Association
reported survey results in which "81% were worried about
accessibility [of personal medical data] by people other than the
healthcare professionals providing their care". Can this dichotomy
ever be resolved?

Development of Biosimilar {*filter*}
Traditionally the pharmaceutical industry has had two major divisions:
large, well-funded 'innovator' companies with the resources to
develop and market new compounds, and smaller 'generics' companies
who provide low-cost copies of patent-expired products. The last twenty
years has seen an explosion of 'biotechs' feeding a new market
derived from recombinant protein technology. Now, as these products
begin to emerge from patent protection, companies and regulators are
both thinking hard about a fourth sector based on a new generation of
'biosimilar' proteins.

Issues in Clinical Research Involving Genetics (Part 1)
In the first of a two-part series exploring current issues in clinical
research involving genetics, members of ICR's Genetic Research
subcommittee look at pharmacogenetics and pharmacogenomics, sample
banking and the role of genetics in diagnostic testing.

CTMS Procurement: The Seven Deadly Sins
Clinical Trial Management Systems (CTMS) help improve trial management
processes and better manage costs. However, the author has identified
seven 'deadly procurement sins' surrounding CTMS. Executives that
fail to consider these issues could find that the CTMS does not meet
their needs and does not optimise the benefits that the technology
could offer their organisation.

Access to Medline & Global Health
The information services available from ICR continue to develop. We are
pleased to announce that all members of ICR now have free access to two
important health databases, Medline and Global Health. Helena
Korjonen-Close, ICR Information Services Officer, explains...

Inspecting Training Records
The Institute's last Trainers' Forum in 2005 aimed to deal two very
active and topical subjects at once: inspections and of training. More
specifically, the meeting considered inspection of training records. It
hit the target, as over forty members squeezed into the Marlow office
to participate in an interactive and challenging session. Gareth Hayes
reports...

Book review: Clinical Trials - A Practical Guide to Design, Analysis,
and Reporting