Quintiles is considering setting up at least two more Prime Sites in
the UK to make the most of what it regards as a still fertile
environment for clinical trials.
The US-based biopharmaceutical services company established the first
of its international network of Prime Sites at Queen Mary, University
of London in 2007.
The company recently gave a further vote of confidence to the UK as a
key location for clinical research by investing in a clinical research
facility – part of the new William Harvey Heart Centre – at the same
site.
Quintiles also has its European headquarters in Bracknell, UK, a Phase
I clinical research facility at Guy’s Hospital in London and a
laboratory and office facility in Edinburgh, Scotland. That amounts to
a total staff of more than 2,000 in the UK market, notes Lindy Jones,
Quintiles’ global head of integrated site services.
Recruitment growth
The UK is “of significant interest to us”, Jones says. While there has
been talk in industry of declining patient recruitment in this market,
it has not been Quintiles’ experience, she points out.
In 2008, the UK’s contribution to total patient recruitment by
Quintiles worldwide was 0.7%. By 2009 it had reached 0.9%, in 2010 it
was 1.4%, and in the year to date 2011 it is 2.2%.
This is at least partly a testament to the success of the Queen Mary
Prime Site in raising the profile of clinical research in the NHS and
enhancing the infrastructure for clinical trials.
Jones describes the site as “very much a collaborative” effort between
Quintiles, Queen Mary, University of London and Barts and The London
NHS Trust.
The initiative originally involved embedding a Quintiles operational
head – James Brooks – within the Trust to “carry the flag for clinical
research at Trust level”. This played a “pivotal role” in bringing some
commercial awareness and strategy to the site, Jones notes.
The new clinical research facility in the William Harvey Heart Centre
will enable the Prime Site at Queen Mary to continue expanding its
contribution to clinical research in the UK, she adds. This chimes with
a national trend towards opening up clinical trials to patients.
“The [clinical research] unit underpins the Trust’s ability to continue
to enhance that offering to patients, both Quintiles research and
non-Quintiles research,” Jones comments. At the same time, Quintiles
does prioritise the Prime Site in terms of the clinical studies it
conducts on behalf of the biopharmaceutical industry.
At the moment it has 50 studies “at one stage or another” within Queen
Mary. Quintiles trials at the site will range from Phase I to Phase IV
and across the spectrum of disease areas.
Dramatic change
In Jones’ view, the UK environment for clinical trials has “changed dramatically” over the last year to 18 months.
“We believe as an organisation that the environment in the UK has
opened up far more to clinical research than we’ve probably seen in the
preceding eight to ten years. I think [it’s] government recognition and
interest – and good intent. The UK remains for us a key market.”
In terms of the local culture and opportunities for change, “in many
ways it’s down to the industry and people like ourselves really to
match the willingness and intent that we’re seeing in the environment,”
Jones says.
Quintiles will be backing up that commitment with more investment in
the UK. Jones regards the Queen Mary site as a “showcase” for the Prime
Site programme worldwide.
“We will probably be looking to bring on an additional two, maybe three
more Prime Sites in the UK,” she adds, noting that Quintiles also has a
“very strong” Partner Site programme in the UK market.
Approval times
There are still some obstacles to conducting clinical trials with
maximum effectiveness in the UK, such as R&D approval times, Jones
acknowledges. “Fundamentally it still takes six to nine months overall
to get [a trial] active in the UK,” she comments.
“If we could bring the UK sites up in three to four months – the way it
used to be – then that’s an additional five or six months to recruit
patients when you’re competing on a global platform.”
Moreover, investigative site contracting in the UK is still “fairly
cumbersome”, despite guidance from the Association of the British
Pharmaceutical Industry, and is subject to additional reviews from as
many as three parties, Jones observes.
Ultimately, she argues, “the more we partner” – with the NHS and clinical investigators – “the more successful we are”.
If both parties can be more aligned in their objectives and “a bit more
strategic” in discussing pipeline opportunities for clinical trials,
everyone can benefit in a climate where patients “are feeling gradually
more empowered” to want to make informed choices, Jones points out.
“And obviously a lot of the cutting-edge clinical research opens up
options and choices for patients that without that simply wouldn’t be
available.”
