Industry Trends From A Twenty Year CRO Veteran

By Rob Wright, Chief Editor, Life Science Leader magazine

Steve Powell is the EVP for PRA, a global clinical research organization (CRO) providing service through all phases of clinical development, which has supported 3,100 clinical trials in more than 80 countries. Powell has over 20 years of CRO and Pharma/Biotech industry experience with a primary focus in operational management and business/system development. Prior to joining PRA he held several leadership positions across the health care and CRO industries. Powell took time out of his schedule to meet with Clinical Leader to provide his executive level insights into present and future industry trends.

Clinical Leader (CL): What are some of the challenges that you see taking place within the clinical market over the next couple of years?
Powell: I think what we've seen in the marketplace in the last couple of years, and will continue, is a lot of focus on how we can do trials differently. I think the way the trial paradigm has changed over that time period needs to be addressed. This is my 21^st year at a contract research organization (CRO) and some of the aspects of how we do trial design hasn't changed in that life cycle. But what we have seen in the last couple of years is a real acceleration in how to tie processes and technology together much more tightly. In what was traditionally a very conservative market, we are now seeing the adoption of technology sitting much happier with a lot of customers, obviously a big focus within our organization as well. What we are starting to see is the aggregation of information, which was siloed before in many organizations. The visualization of that data in one place and really everybody that I've talked to, in terms of the technology environments, pharma companies, multiple CROs of all sizes, are all looking into this integration strategy and how they can utilize their data to drive a much more efficient clinical trial process. The old way of doing it costs a lot of money and takes a lot of time. Based on where we are and the financial dynamics of the market this can't continue. The investment is really heavy on bringing those systems together, utilizing the data that everybody has within their walls, trying to create some predictive capabilities off of that information, and then providing a seamless approach to data access, to both customers and ultimately to our site staff, to maintain patient safety on the trials we run and also to run much more efficient trials.

CL: What has been key to the acceleration you describe and the un-siloing of data?
Powell: I think the acceleration points have come from two places. Firstly, the technology development is a lot stronger and a lot more accessible now. We also see that as the model has changed for large pharma, even in biotech with financial access being much more difficult to do, then people have to do things differently, whereas before, over the last fifteen plus years, we were quite happy to move along like we were doing it. People are much more focused on trying to do things differently, utilizing technology to the best of their ability, because the financial dynamics have to change. We cannot spend a billion dollars in ten years on every single trial to have it fail in the last two or three years of its development. You need to make decisions much earlier in the process. You need to make those decisions with a much higher degree of accuracy than before, and that's where the data aggregation and the data information is much more prevalent. Rather than the group of people making subjective statements like, "I think this drug is going to do this or isn't going to do that," now it's hard fact. It has to be early on, has to be integrated and has to be delivered in the standard way. I think that's where we're seeing the acceleration come from.

The second question, on the silo end, it really has just developed out of the growth of some organizations. When the area focuses on one area, like clinical operations focuses on the site and the maintenance of data from there, it moves down the chain to data management, bio statistics, medical record publishing, and what we need to see is all of that data aggregation come together. What we're starting to see is companies looking at the old structures and definitions of people's roles and tasks within a clinical trial, and starting to erode some of the barriers that existed between certain functions and certain groups. That is driven by technology as well, whereas before, in a paper-based world ten years ago, the only people who saw the full case book was either the clinical research assistant (CRA) or the data management person, but never the same version of it. Now, you're starting to see, through electronic data capture (EDC) applications or the aggregation of data in a corporate environment, anybody can access that information and can make transactions within the systems that they're working on. If you start to take those roles, which were very independent before in many organizations and blend them together, we have less hand-offs, which is where the normal points of failure are. We have much more visibility into the full process of a trial, rather than just in different segments, and with that then, we can drive different process and efficiency change, which ultimately makes a financial impact on projects and the delivery timelines that we're working to.

CL: What do you see as being key to being innovative?
Powell: In the phase 2, 3 and late-phase area, everybody was focused on the underlying commodity system, so looking at clinical trial management systems (CTMS) and what EDC systems do you use, and which e-pro provider did you utilize? How were you providing data sets at the end of the study? I think what we're starting to see with people that we work with, when we have a sponsor that really doesn't have that infrastructure themselves, is don't worry about what the underlying commodity systems are. Worry about the data presentation that you're going to get and the deliverables of standard data sets that you're going to get at every single point during the study that you can access and review. What we're focused on, then, is the integration capabilities that are starting to create the integration fabric across organizations, that's where the key focus is. Don't worry about the underlying systems. There are plenty of good systems out there. They all pretty much do the same things. I think we are past the days where functionality of an EDC system or CTMS system was what everybody was looking at. It's now almost a given that they all do roughly the same thing. There are obviously some that are better than others, and that's why we have market leading positions. But underneath it all, for us, we're trying to say to both our customers and our users internally, we want you to not even have to understand what the underlying commodity systems are. We want you to work at a higher level where the data is accessed for you, without having to drill down into each individual system and seeing the full-picture of how a trial and data is coming together.

CL: What do you see as being the next big game changer in this industry?
Powell: I think the acceleration point has started somewhat in the U.S. in terms of access to public patient data. We're now seeing stronger moves around social media and people driving their own capabilities. We do predominantly oncology work and high-end central nervous system (CNS). We now have patient advocacy groups that are really driving clinical trials. The analogy is, before, we would build a site and they would come. Now it's a case of we identify a site where the population of people are. Through community access, through social media, through advocacy groups, we're now starting to drive where we need to put sites, rather than creating sites and having patients drive towards them. I think that's one area that we're going to see big changes to. I think the other area is direct from patient data. We've seen some examples recently of siteless trials. Now, we know they're in late phase, but the more data that we can pull directly from a patient through direct communication, direct device interaction, then obviously, the need to check that data is eliminated and the number of review steps that we're working on. I think we're seeing a drive towards much more focused, scientific review of a protocol that it's really doable by looking at the patient population and seeing if it really exists before we set off on a multi-million dollar trial path,. By using social media, publicly available data, and then marrying it together with our trial performance information. We're starting to see a much more focused move towards collection of data using cellphone technology, to device-delivered data directly from patients. You're never going to get away from some of the more serious oncology-based studies, but for collection of all data from society, I think we'll start to see a blend that will help in the streamlining of the processes in the next couple of years.

CL: Can you elaborate a little bit on how that mindset has changed on patient advocacy groups?
Powell: Predominantly, five, ten years ago, the advocacy groups were higher-level groups who were almost demanding things with regards to a more silent group of patients that you never really heard directly from. You would have a few individuals that would try and drive. Now you've seen the mass of people really driving through social media what they want, that they're interested, they're out there looking for trials, they want to understand what's available to them rather than being told, "This is your easiest options." We've talked to a couple of groups that analyse the data that people blog, and the information they write is amazing. We've now seen some pretty sophisticated tools that are able to digest that information through word recognition, to piece together all those patient profiles and population bases. I wouldn't go as far as epidemiology of what's going on, but it really is getting closer. The patients are driving it.

I think that it's almost that the pyramid has turned 180 degress. Whereas advocacy before was a small group at the top and a lot of silent underneath, now it seems to be a lot of vocal at the bottom, and in huge numbers, driving up the demand and seeking that information themselves, rather than relying on one or two people to represent them. I think we'd also like to see people who want to keep their personal data a lot closer to them. We've seen a couple of failures with regards to personal health records, with Microsoft Healthvault and Google health and things like that, but that is coming. We're seeing more and more of that and how we as industry can start to access that data is really going to be a game changer. It's not tomorrow, but I think in the next five to ten years, while we'll see some of the aggregation of our trial clinical records cut from sites, I think we'll see a much stronger push from patient-held information with regards to their records and information. The marrying of those two things together is really where we're going to have a big effect on clinical trial development.