Big CROs become patient recruitment players

Big CROs become patient recruitment players
SCRIPT-09 November 2010
Jonathan Hare

Patient recruitment organisations are coming under increasing pressure from the modern multi-faceted global CRO. Jonathan Hare weights up the future of the PRO and how it can survive in today's strategic outsourcing environment.
The importance of patient recruitment to the clinical trials process is recognised both by sponsors and providers of all kinds of outsourced services, as are the advantages of having all aspects of a study performed by a single supplier. As CROs increasingly market themselves based on their own patient recruitment capabilities, and as sponsors form ever closer ties with their CRO partners, is the industry close to a tipping point that could see dedicated patient recruitment organisations (PROs) consigned to the history books?
There appears to be broad consensus that this is a critical time for the patient recruitment industry. In April last year, D Anderson & Co, one of the largest and most established PROs, joined seven other firms to form a new advocacy group, the PRO Steering Committee, to promote "greater collaboration and co-operation among PROs". This recognition of shared purpose between otherwise competing firms, reflected "several market trends which underscored the need for greater collaboration and co-operation among PROs", Dr Diana Anderson, D Anderson's founder, said at the time.
"I think the industry is at a crossroads," she told Scrip Clinical Research. "We're working together to see where we go together. There are some new dynamics appearing and the pharma industry is looking at where to put its dollars."
Chief among these new dynamics is the increasing scale and capabilities of the larger CROs, specifically in patient recruitment, which has put them in direct competition with PROs. "We are increasingly going head-to-head with CROs for business," said Dr Anderson, "as CROs are now pushing patient recruitment as a speciality. This business used to go to PROs, but now more and more of it goes to CROs." To give one example, "just one week ago we lost a client to a CRO as that client believed that it would be easier to stick with a single provider", Dr Anderson confided.
In the past, pharma companies usually took care of site selection and handled their own clinical trials, while patient recruitment work was often left to dedicated PROs. However, in recent years, the pharmaceutical industry's outsourcing drive has meant that almost a third of all clinical research is now performed by external service providers, dominated by a handful of giant CROs. Many of these have spent the past five years boosting their capabilities in the hope of becoming 'one-stop-shops'. With patient recruitment recognised as perhaps the most important bottleneck in drug development, and with the increasing size and complexity of trials, the evolution of such capabilities by the larger firms was a logical step.
"Although many smaller CROs still lack these capabilities, some of the very large firms now have equally large patient recruitment divisions," said Dr Anderson.
Of course, the size of top-tier CROs gives them other advantages in terms of patient recruitment. "Large global CROs especially are well positioned to meet the patient recruitment needs that sponsors have, since we have the full gamut of services in-house as well as the requisite reach into international markets," Dr Joe Avellone, corporate vice-president of operations for Parexel International, told Scrip Clinical Research. "At Parexel, we have developed the sophisticated use of patient databases and multi-media outreach to support those kinds of trials that would benefit from such outreach."

has the market changed?

According to Kenneth Getz, senior research fellow at the Tufts Centre for the Study of Drug Development, CROs have been eyeing the patient recruitment market for almost 15 years. Back in the 1990s, a number of the most established firms started making moves into this space by acquiring dedicated recruitment companies. Quintiles was first off the mark, with its purchase in 1997 of the communications firm Butler Clinical Recruitment. Others have since followed suit. However, Mr Getz did not consider these first forays as a success.
"A number of CROs started to rebrand to emphasise patient recruitment," Mr Getz told Scrip Clinical Research, "but it became apparent that the market was not yet ready. Drug companies used to hire service providers to perform single tasks and the task of CROs was not seen to include patient recruitment."
Things appear to have changed. "Nowadays, CROs are on the frontlines with the site," said Mr Getz. "They're trusted as partners by sponsors and because of this they now have the leverage to impact patient recruitment."
Recruitment is a specialised capability and difficult to develop autonomously. For this reason, Mr Getz suggests, CROs have increasingly been buying in this expertise, snapping up specialists from drug companies and PROs. Parexel and Kendle, for example, both appointed new patient recruitment executives last year, Parexel with the appointment of the former Merck & Co patient recruitment specialist, Lars-Olof Eriksson, who became vice-president of its Start-up and Accelerated Recruitment Team (START), and Kendle by hiring Jeffrey Zucker, formerly of Lilly and Merck & Co, as its new head of patient recruitment. If this process continues, Mr Getz reckons "we may see CROs actually buying up some patient recruitment firms in the near future".

why the shift?

Why buy the expertise when you can rent services from existing providers? Clearly, the rise of the CRO in recent years is a salutary lesson that sometimes it is easier and more effective to outsource work to specialists than to build and maintain an internal capability.
However, it appears that it is overwhelmingly pharma companies that use the services of PROs, with very little business being passed down from CROs. Dr Anderson should be ideally placed to comment, but she said that her company had never received any business directly from a CRO. Of the patient recruitment work undertaken by D Anderson, 75% comes directly from the pharma company with no CRO involvement – usually from big pharma companies handling their own clinical trials – and of the remaining 25% of business where a CRO is involved, the company is still hired by and reports to the sponsor.
D Anderson has never marketed its services directly to CROs. "In fact, we have had only one small job in all our years directly from a CRO and that was for our more creative media and marketing services," said Dr Anderson. She points to a fundamental conflict of interest. "CROs are hired to find sites and recruit patients, and if CROs try and outsource their recruitment needs, the pharma sponsor may question the amount they are paying them."

specialist knowledge

Dedicated patient recruitment firms have never been under such pressure. However, this does not mean that dedicated PROs need to resign themselves to shutting up shop.
Paradoxical as it may seem, the glut of work for CROs may actually prove to be a positive. Although global CROs with large-scale recruitment divisions have typically not outsourced work to PROs in the past, passing off the responsibility for recruitment for at least some of their projects may become a strategic possibility in the future, as these CROs find themselves tied into long-term strategic partnerships with big drug firms, leaving many oversubscribed.
Secondly, the more specialist capabilities of PROs are likely to remain difficult to replicate. "I think there's room for them, even if only as providers of more speciality or niche services," Mr Getz remarked. "The PROs have a lot more expertise in things like recruitment initiatives and placing advertising, and these are extremely specialised capabilities."
Importantly, while mainstream advertising agencies can work with CROs to replicate many of their functions in more developed countries, this is unlikely to be the case in emerging economies. So, success for dedicated PROs in the near future may lie with their specialist knowledge of patient recruitment in countries outside of the US and Western Europe. "You can go to a normal advertising agency in mature markets and replicate many capabilities, but in emerging markets it is a different story," Mr Getz said. "I imagine these markets are where a good deal of the current business of PROs is migrating."
Perhaps most heartening for PROs is the fact that the industry has no uniform approach to outsourcing. Different sectors outsource in different ways and large firms behave differently from small firms. While big pharma may be happy to offload the running of its trials entirely to a CRO, "small drug firms are still happy to go to several small providers", said Mr Getz.
Ryan McGuire, author of a recent study "Clinical Trial Patient Recruitment: Accelerate Enrolment, Increase Retention and Reduce Costs", from Cutting Edge Information, told Scrip Clinical Research that "based on our data there is no indication that long-term contracts between sponsors and CROs will squeeze patient recruitment vendors out the picture".
"Most of the outsourcing decisions are specific to a company's strategic approach. Some companies are interested in turnkey solutions for clinical development. If that is the case then the patient recruitment vendor may not get a significant piece of the pie. At the same time a long-term contract may not incorporate the patient recruit portion of the process. Some companies prefer to have specialised expertise handle the different aspects of development, such as drug safety, patient recruitment, site management, etc. In these cases, patient recruitment vendors will continue their relationship with sponsor organisations," he said.
While there has been much talk of competition, is it possible that CROs and PROs might be able to work together? It might seem that the smaller CROs would benefit most from taking advantage of dedicated recruitment experts. While large global CROs may not typically outsource work to PROs, "smaller CROs do work with PROs more often, for trials requiring high patient volumes, especially in the US", commented Parexel's Dr Avellone.
However, D Anderson has reportedly been approached by "several large CROs" for frank discussions on how using the services of PROs could possibly benefit the ability of these firms to perform clinical trials. While nothing has yet come of this ("they feel it's a competitive situation and that they could use their budget differently", Dr Anderson said), it raises encouraging possibilities that could have benefits for both parties.
Whatever the future holds for dedicated patient recruitment firms, the formation of the PRO Steering Committee shows that they believe they still have a place in the industry. In Dr Anderson's own words: "PROs need to step up and prove that they can do it better. It is a touchy subject and we do not want to alienate CROs, but our business requires that we establish ourselves as the recruitment experts."
Jonathan Hare is the assistant editor of Scrip Clinical Research.