The Dublin-based contract research organisation (CRO) is planning to dramatically boost the number of workers it has in this field in Europe from one to 75 over the next year, to match its number of operational staff in the US.
The company plans to achieve this via organic growth, along with the acquisition of a European firm similar to US-based firm Ovation, which it bought in July 2006, Jeffery Trotter, vice president of Icon Clinical Research's Lifecycle Sciences Group, told Outsourcing-Pharma during an interview at the annual US Drug Information Association (DIA) meeting in Atlanta.
Since acquiring Ovation, ICON has had the ability to run observational research programmes internally without having to outsource them to external third party providers, as well as pitch for larger studies that it had previously been unable to, said Trotter.
ICON has now absorbed Ovation fully into the company and has just announced the creation of a new business unit dedicated to observational research, called the Life Cycle Sciences group.
Until recently, all its observational business was coming from US clients, where Ovation was already established in the market place.
However, over the last few months ICON has managed to gain attention within Europe and has signed up 10 new clients.
"Our European business development teams are now seeing a lot of opportunities," said Trotter.
"Ever company is now showing interest in what is happening with their products post-registration in the real world and needs to [or should] document this."
Observational research is usually carried out in the form of a large, uncontrolled research study (a patient registry), designed to capture data on what is happening to patients when a drug is used in the 'real world.'
They are carried out post marketing approval, as a regular Phase IV study, although they are run differently to a Phase IV trial as they are less exploratory and hypothetical in design.
By gaining a dedicated observational research division, ICON has joined the ranks of the five out of the top ten CROs that have "robust capabilities" in this area. There are also a handful of niche non-global players kicking around in this field, although Trotter believes that over the next few these companies will be "snapped up" by larger firms looking to gain this internal capability.
"There are not many of these companies to go around and so those that exist are hot property," he said.
According to Trotter, the number of observational research programmes is expected to double or triple within the next three to five years, and the market is growing at a compound annual growth rate in the mid-to late teens.
"In the last two to three years the number of mandatory observational research studies has increased, while some are voluntarily being done at the discretion of the pharmaceutical sponsor," he said.
"Regulatory bodies are now also increasingly asking drug manufacturers to complete patient registries as they are now recognising the benefits that such data bring to scientific understanding of their drugs, whilst still accepting their limitations."
Other reasons companies are now choosing to run such trials include attempts to gain a new indication, or gain a commercial, marketing or reimbursement advantage through new cost-effectiveness, quality of life, efficacy, safety or tolerability data being accrued.
"Companies are spending a lot of money commercialising their products so if they can do it in a different way then this is better," said Trotter.
"Patient registries may be able to use a different approach to the way the site is set up, recruitment and monitoring is carried out and the data collected, for example. In this way they can often be done much more cost- and time-effectively than typical Phase IV trials."
Speaking on the challenges in this field, Trotter said that it can be difficult to bring together parts of organisations that are not used to working together, i.e. clinical research and marketing.
Such studies also require a mindset change, because it is a new concept to many firms and their first instinct is to try and thrown a patient registry into a typical clinical trial template, but it just doesn't fit, Trotter added.
Meanwhile, Western Europe may not be the last stop for the firm in the near future.
"We are seeing a geographical shift in these trials from being US-centric to global, particularly for orphan diseases," said Trotter.
"We have been particularly active in Eastern Europe, especially Poland, Lithuania and the 'stans - these are a continued area of growth for us."