Clinical trials in every therapeutic area have become increasingly complex. In two ViB events held in June 2009, the first in Brussels focusing on trials in the central nervous system and the second held in Washington that discussed supply challenges, the importance of designing a watertight trial was stressed time and again.
When clinical trials are outsourced, defining clear aims, boundaries and desired results becomes vital. These challenges will be discussed in full at the ViB Outsourcing in Clinical Trials East Coast conference in Boston 30 September–1 October 2009.
Solace Pharmaceuticals executive director and development projects leader Kevin Pojasek says after working for a venture capital firm he helped Solace to focus on new insights into pain biology. With $15m of private backing and with previous head of European development for Pfizer Eliot Forster as its CEO, the business began focusing predominantly on one novel therapy, hoping to break the mould of what has gone before.
After signing a deal with a major pharmaceutical firm for the drug and setting up UK and US bases, Solace Pharmaceuticals' search for a suitable contract research organisation (CRO) to conduct a global Phase IIa neuropathic pain programme began. Natalie Coomber caught up with Pojasek to discuss how the firm went about managing its outsourcing relationship.
Natalie Coomber: How did you choose the partners to work with when it came to developing the clinical trials?
Kevin Pojasek: As a small company with one clinical-stage asset contributing the predominance of our value, it was critical to get our CRO relationships right from the start. We spent several months making sure we managed the partner selection appropriately.
Part of the framework that we use is specification-led contracting. We approach a group with clear aims and outcomes for the final work product to establish an upfront understanding of what we want to achieve. We then rely on the group's expertise to develop and implement a plan for achieving our desired outcome.
Obviously cost was an important factor in our CRO selection process, although at the end of the day we didn't choose the cheapest partner. We needed a group that really understood us as a business and how we differ from other biopharma companies.
The experience and personalities of the actual project team members working on our study were also a critical factor in our decision making.
NC: Did you choose one full-service CRO or a series of different contractors?
KP: A full-service provider is great for a small company. However, if it is an amalgamation of individual providers that have been cobbled together over the years, you really have to assess whether there is a reasonably good set of experiences across the different teams contributing to the study.
We looked at more piece-meal providers which would allow us to choose the best in a given clinical trial support area or geography and put them together ourselves. While this was attractive from a cost perspective, it was going to be cumbersome for our team to work with numerous individual providers in this fashion.
In the end we chose a full-service CRO, INC Research, along with a couple of peripheral providers that can conduct additional analyses for us. This way, the meat of the study in terms of patient recruitment, monitoring and data management all sits under one umbrella.
NC: What timeframe are you working towards?
KP: After starting in January 2009, we recruited around 150 subjects globally in six months. Historically, it has been challenging to recruit neuropathic pain subjects so we were pleased to finish a month ahead of schedule against our already aggressive timelines.
NC: Where did you recruit your subjects from?
KP: Due to access to an open IND, we recruited just over half our subjects in the US. The other half are split between from Russia, Germany and India; countries that all came back strong from our original feasibility assessments.
We view India in particular as an opportunity for future clinical development because of the access to a large patient population, increasingly efficient regulatory and ethics committee processes and, of course, the well-known cost advantage. In our ongoing trial, we contracted five Indian sites to get our feet wet. If everything goes well, we would certainly look to add more sites there in future.
NC: Did you employ an incentive scheme to encourage INC Research to stick to specific deadlines?
KP: We did look at implementing a milestone-based payment structure but decided collectively that clinical trials contain too many intangibles to assign specific dates to significant cash milestone payments. Instead we developed a transparent relationship and strong team collaboration that has led to us meeting or beating our timelines. We also have had very good senior management visibility within INC Research that allows for a rapid escalation path when something goes awry.
NC: Do you think such a lack of clear goals can be a problem pharmaceutical companies will come across when managing their relationships with CROs?
KP: I believe a common mistake for a sponsor occurs when they don't think through exactly what they would like to achieve with a clinical study and why. Without this clarity of thinking it's impossible to work with CROs through specification-led contracting.
I also believe it's important to consider the CRO operations team as an extension of the sponsor team. Having a transparent relationship provides the context for difficult decisions and requests and makes it more likely that the CRO team will go the extra mile for your study. Too often CRO teams are looked down on by the sponsor, which can often result in a less than ideal outcome.
NC: How do you think the practice of carrying out clinical trials has developed around the world?
KP: Clinical trials have quickly evolved from single sites with one investigator to massive global undertakings. Clinical development continues to become more complicated and expensive, leading to a barrier to entry for biopharma start-ups wanting to get involved in running meaningful clinical studies. With that said, the larger scale of clinical trials allows for more rapid recruitment than in the past. It really comes down to balancing efficiency with scale and cost.
There has also been an increasing emphasis on safety from global regulatory agencies. This is forcing sponsors to add larger safety assessments to their late-stage development or post-marketing plans, further increasing the overall cost of clinical trials.
NC: Is there enough business to support the number of established CROs?
KP: My guess is that there will be more and more consolidation in the CRO arena, especially given the global economic downturn. Hopefully this will lead to more efficient organisations if companies can address their weaknesses by merging with complementary groups.
Big pharma companies are also becoming leaner organisations which, in the development arena, could certainly lead to more clinical outsourcing. I would also expect to see an increasing number of biopharma start-ups tackling outsourced clinical development as the economy begins to recover.