Drug development is one of the most competitive and unforgiving industries in the world. As such, pharmaceutical and biotechnology companies are constantly striving to cut costs and boost efficiency when it comes to developing new products.
Outsourcing the clinical trial process to a team abroad has been embraced by the industry as a method of saving time and money while gaining access to large patient bases. The outsourcing process is, however, complex, requiring a great deal of communication and management expertise to maintain standards and achieve results.
Here, Chris Lo talks to Larry Burnstein, senior director of clinical research at biotechnology company Genzyme Corporation, about his experience of outsourcing and how to get the most out of research teams in such diverse countries as Russia, China, India and Brazil.
Burnstein will be making a presentation at the September 2010 Outsourcing in Clinical Trials Northeast conference in Boston.
Chris Lo: What is Genzyme's experience of outsourcing clinical trials?
Larry Burnstein: Genzyme outsources many of its trials, both from a functional service provider model as well as global outsourcing to one of its preferred providers. We outsource both in a functional service model as well as total outsourcing.
CL: What countries are particularly promising when it comes to outsourced clinical trials?
LB: I guess there are different approaches, but if you're looking for patients that are naive (have not received particular treatments) that make better candidates for trials, you're looking at countries like India and China, which have fairly large patient populations.
Certainly people are looking at Brazil and other Latin American countries – besides Brazil there is Argentina and Mexico, which offer some great opportunities. And then of course there's Russia which also has a fairly large patient population and offers some unique opportunities to treat naive patients. So I think those are some of the areas that people are looking at now.
It's not unusual to have global trials where there are 20 or 30 countries involved. Some go to countries that they believe are necessary for approval, as well as getting patients. Some may prefer Italy or Germany over Russia or some other countries because they may have a larger population of certain types of patients. It's those criteria and the size of the patient population in those countries that really drive where people go.
CL: Can you talk about the sponsor / provider relationship when it comes to outsourcing clinical trials?
LB: I think what most people don't focus on are the relationships that are necessary to make the programme successful. There are certainly challenges in data management and clinical monitoring and getting drugs into countries – I think those are really important challenges for a trial and they often impact how the project gets completed, as well as things like site selection and patient recruitment.
I think little time is given to how well the team is doing on a regular basis in terms of dealing with these issues and effectively working through problems that they may be having, as opposed to the sponsor saying, "You're responsible for this; you've got to fix it." People should be saying, "How are we going to work together to get these things fixed and what is the best way to sort out these issues, in a non-threatening, collaborative way?"
CL: What is the best way of ensuring that an outsourced CRO is qualified to carry out the necessary trials?
LB: A lot of it goes to the staff they have involved, that are committed to the programme – their expertise, experience and how long they've been working in that therapeutic area. Some areas are not as critical as others, but there are some where we really need to have people who have been working in those areas for a while. But I really think it comes down to their level of experience. Also, you need to create an environment on the team that allows people to disagree if they don't think a decision is made correctly.
CL: How do you go about striking the balance between achieving cost savings and maintaining high standards?
LB: It's a tough one .For the mid-size biotech to the large pharma companies, what they try to do is micro-manage the CRO by having very similar staff to their company looking at what the CRO is doing. So they're outsourcing it and then they're spending time either micro-managing or getting involved in issues that you should let the CRO resolve because they are responsible for that activity. There's still a lot of that going on and I think some companies may be better at it than others, but I think that this requires a different type of approach to dealing with your CROs.
CL: So is it important to regularly visit and assess the performance of CROs as trials are progressing, or do you prefer to give researchers some breathing space after a contract is awarded?
LB: What you need to do is establish some metrics that you can easily pull out and look at together to see how well they're doing. There are some simple metrics that one can use – the number of deviations a site has, the number of queries they have, how responsive they are. But it's important for the sponsor and the CRO to agree on what those metrics are going to be and how they are going to be tracked and managed.
CL: The perception of any outsourcing process is often that quality is sacrificed to achieve value – what has your experience been with outsourced clinical trials? Do you think you've achieved the same quality with outsourced trials as you would have if you were doing them yourselves?
LB: I think what happens, and why it's very difficult for us to move away from more oversight of the CRO, is that we don't see the level of quality that we would expect if we were doing the trial ourselves. I think that's why there's some angst in terms of outsourcing. These need to be discussions you have with your partner in terms of how you're going to control and manage that.
CL: How important is it for a CRO to be transparent when it comes to ethical concerns like exploitation of the local patient base?
LB: I think it's very concerning. Because at the end of the day, what we don't want to happen is for those things to reflect negatively on Genzyme. So they need to work with the same ethical standards that we would use for bringing patients into trials, how they are treated and how they are evaluated and the reasons for participating in the trial. We would be very concerned if ethical standards weren't being vigorously employed. Ethics have to be not only from a patient enrolment point of view, but also in terms of ensuring that the positions are ethical and there's a high level of quality review going on to make sure the data is robust. Those things need to be in place.
The Outsourcing Clinical Trials Northeast conference will take place on 29-30 September in Boston, Massachusetts.
Clinical Trial Supply Asia will take place on 14-15 September in Singapore.