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


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