Quintiles plans more Prime Sites in UK
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.
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.
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.
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.”